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 amendment filed July 2nd, 2025 has been entered. Claims 1, & 23-24 are amended. Claims 2-3, 7, 9, 16-20, & 25-27 are canceled. Claims 28-31 are new. Claims 1, 4-6, 8, 10-15, 21-24, & 28-32 remain pending (see below objection).
Response to Arguments
Applicant’s arguments with respect to claims 1, 4-6, 8, 10-15, 21-24, & 28-32 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; as necessitate by amendment.
Claim Objections
The numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not).
Misnumbered claims 29-31 have been renumbered to 30-32; currently there are two claims with the number 29; the second claim number 29 should be claim 30, and claim numbers 30-31 should be claim numbers 31-32. The examiner notes that hereinafter the first claim 29 will be referred to as claim 29, the second claim 29 will be referred to as claim 30, claim 30 will be referred to as claim 31, and claim 31 will be referred to as claim 32.
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 28-29 & 31-32 (see above objection) 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 28 recites “an active electrode assembly” and “a return electrode”; claim 1 introduces “an active electrode assembly” and “a return electrode”, therefore it is unclear if “an active electrode assembly” and “a return electrode” (of claim 28) are the same as or in addition to the “an active electrode assembly” and “a return electrode” (as introduced in claim 1), which renders the claim indefinite. For examination purposes, the examiner is considering them to be the same.
Claim 29 (the first claim 29) recites “an active electrode assembly” and “a return electrode”; claim 1 introduces “an active electrode assembly” and “a return electrode”, therefore it is unclear if “an active electrode assembly” and “a return electrode” (of claim 29) are the same as or in addition to the “an active electrode assembly” and “a return electrode” (as introduced in claim 1), which renders the claim indefinite. For examination purposes, the examiner is considering them to be the same.
Claim 31 (misnumbered claim 30) recites “a return electrode assembly” and “an active electrode”; claim 30 (second misnumbered claim 29) introduces “a return electrode assembly” and “an active electrode”, therefore it is unclear if “a return electrode assembly” and “an active electrode” (of claim 31) are the same as or in addition to the “a return electrode assembly” and “an active electrode” (as introduced in claim 30), which renders the claim indefinite. For examination purposes, the examiner is considering them to be the same.
Claim 32 (misnumbered claim 31) recites “a return electrode assembly” and “an active electrode”; claim 30 (second misnumbered claim 29) introduces “a return electrode assembly” and “an active electrode”, therefore it is unclear if “a return electrode assembly” and “an active electrode” (of claim 32) are the same as or in addition to the “a return electrode assembly” and “an active electrode” (as introduced in claim 30), which renders the claim indefinite. For examination purposes, the examiner is considering them to be the same.
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, 4-6, 8, 10-13, 15, 21, & 28-32 are rejected under 35 U.S.C. 103 as being unpatentable over Bakos et al. (US 20140039491 A1), hereinafter “Bakos”, in view of Behzadian (US 20050288663 A1), hereinafter “Behzadian”.
Regarding claim 1, Bakos discloses a surgical instrument comprising: a sheath configured to be inserted into a cavity of a patient's head ([0054]; Figure 4—element 40); and an ablation catheter disposed within the sheath, the ablation catheter comprising (i) a shaft defining a longitudinal axis and terminating at a distal tip ([0054]-[0055], [0064]-[0065], & [0067]; Figures 1 & 4—elements 18 & 28; with the shaft being the elongate member 18, which may be retracted and deployed relative to the sheath 40; the longitudinal axis being the longitudinal axis of the shaft 18; the distal tip being the distal portion of elongate member 18 extending distally of proximal electrode 22 and including tip 28), and (ii) a proximal electrode and a distal electrode disposed on the shaft ([0067] & [0068]; Figure 4—elements 22 & 21), the proximal electrode and the distal electrode being operable to deliver RF energy to tissue to thereby ablate the tissue ([0044] & [0060]), wherein (i) the distal tip operates as an electrode assembly ([0065]; Figure 4—element 28; the distal tip 28 may be configured to deliver electric current and may be an electrode) and one of the proximal electrode and the distal electrode operates as an active electrode assembly, and (ii) the other of the proximal electrode and the distal electrode operates as a return electrode ([0060]; the proximal electrode 22 and the distal electrode 21 may be operated in a bipolar mode; wherein the distal electrode 21 may have a first polarity and the proximal electrode 22 may have a second opposite polarity), the ablation catheter being selectively translatable relative to the sheath between a proximal retracted position in which the proximal electrode and the distal electrode are housed within the sheath to thereby prevent the proximal electrode and the distal electrode from radially expanding from a non-expanded state to an expanded state, and a distal extended position in which the proximal electrode and the distal electrode are exposed from the sheath to thereby permit the proximal electrode and the distal electrode to radially expand from the non-expanded state to the expanded state for contacting tissue ([0054]-[0055], [0061], [0064], & [0067]; Figures 1, 2, & 4—elements 22 & 21), the proximal electrode and the distal electrode each being selectively longitudinally translatable relative to each other along the shaft ([0067]; Figure 4—elements 22, 21, & “d”; the proximal electrode 22 and the distal electrode 21 may be slidably or theadably disposed on the elongate member/shaft 18 so that the distance “d” between the electrodes may be adjusted by advancing or rotating the electrodes relative to one another).
Bakos does not disclose the distal tip and the one of the proximal electrode and the distal electrode operates as the active electrode assembly.
Behzadian discloses an ablation catheter comprising a distal tip ([0027]; Figures 3A-3C & 6—element 22), a proximal electrode ([0027] & [0028]; Figures 3A-3C & 6—element 16), and a distal electrode ([0027]; Figures 3A-3C & 6—element 20); wherein the distal tip and the one of the proximal electrode and the distal electrode operates as the active electrode assembly ([0006], [0010], [0028], & [0033]; Figures 3B, 3C, & 6—element 16, 20, & 22; the bipolar generator is configured to create dissimilar polarity between three or more electrodes such that the total surface area of the electrodes with a high voltage polarity is unequal to the total surface area of the electrodes having a return polarity; the polarity of the three electrodes may be altered individually to create different current densities).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the electrode distal tip and the active electrode assembly, as disclosed by Bakos, to include wherein the distal tip and the one of the proximal electrode and the distal electrode operates as the active electrode assembly, as taught by Behzadian, as both references and the claimed invention are directed toward ablation catheters comprising a plurality of electrodes configured to operate in a bipolar mode. As disclosed by Behzadian, the polarity of the three electrodes may be individually altered such that the distal tip and one of the proximal electrode or distal electrode may operate as active electrodes while the other of the proximal electrode or distal electrode operates as a return electrode, this configuration creates dissimilar surface areas that allow for the current density and the electric field to be higher around the electrode with the return polarity, therefore resulting in lesion formation around the electrode with the return polarity ([0010], [0011], [0028], [0029], & [0033]-[0034]). 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 electrode distal tip and the active electrode assembly, as disclosed by Bakos, to include wherein the distal tip and the one of the proximal electrode and the distal electrode operates as the active electrode assembly, as taught by Behzadian, as such a modification would allow for the ablation device to create dissimilar electrode surface areas in order control the current density and lesion formation in tissue.
Regarding claim 4, Bakos in view of Behzadian disclose all of the limitations of claim 1, as described above.
Bakos further discloses the proximal electrode and the distal electrode comprising a resiliently biased and electrically conductive material ([0070], [0071], [0075], & [0081]; the electrodes may comprise expandable frameworks that include energy delivery surface and comprise superelastic materials).
Regarding claim 5, Bakos in view of Behzadian disclose all of the limitations of claim 4, as described above.
Bakos further discloses the proximal electrode and the distal electrode being resiliently biased radially outwardly relative to the longitudinal axis such that the proximal electrode and the distal electrode are configured to be radially compressed by the sheath when the ablation catheter is in the proximal retracted position, and such that the proximal electrode and the distal electrode are configured to resiliently radially expand from the non-expanded state to the expanded state in response to the ablation catheter translating from the proximal retracted position to the distal extended position ([0054]-[0055], [0061], [0064], [0067], [0081], & [0088]; Figures 1, 2, & 4—elements 22 & 21).
Regarding claim 6, Bakos in view of Behzadian disclose all of the limitations of claim 4, as described above.
Bakos further discloses the proximal electrode and the distal electrode have mesh configurations ([0070]-[0071], [0081], [0088], [0117]; Figure 22—element 20).
Regarding claim 8, Bakos in view of Behzadian disclose all of the limitations of claim 1, as described above.
Bakos further discloses the distal electrode being disposed on the distal tip such that at least a portion of the distal electrode is distal of the distal tip ([0054]-[0055], [0064]-[0065], & [0067]; Figures 1 & 4—elements 18, 21, & 28; the examiner is considering the distal tip to be distal portion of elongate member 18 extending distally of proximal electrode 22 and including tip 28; as the distal electrode 21 extends of the distal tip; it is the examiners position that at least a portion of the distal electrode 21 is distal of a portion of the distal tip).
Regarding claim 10, Bakos in view of Behzadian disclose all of the limitations of claim 1, as described above.
Bakos further discloses the distal tip comprising a rigid electrode ([0065]; Figure 4—element 28; the distal tip 28 may be configured to pierce tissue and anchor the device and may comprise an electrode; it is the examiners position that the electrode of the distal tip 28 would need to be sufficiently rigid in order to allow the distal tip 28 to pierce tissue and anchor the device).
Regarding claim 11, Bakos in view of Behzadian disclose all of the limitations of claim 1, as described above.
Bakos in view of Behzadian disclose (a) the surgical instrument of claim 1 (as described in the above rejection of claim 1).
Bakos further discloses a surgical system comprising: (b) an RF energy source operatively coupled with the proximal electrode and the distal electrode; the surgical instrument being operable to energize the proximal electrode and the distal electrode with RF energy from the RF energy source, the proximal electrode and the distal electrode being configured to deliver bipolar RF energy to tissue for ablating the tissue ([0044], [0054], [0058], [0060], [0067], & [0119]; Figure 1—element 11).
Regarding claim 12, Bakos in view of Behzadian disclose all of the limitations of claim 1, as described above.
Bakos further discloses the ablation catheter including a navigation sensor, the navigation sensor being operable to generate a signal indicating a position of the navigation sensor within a patient ([0065] & [0110]; the distal end 28 may include a sensor that is configured to provide feedback to the user regarding whether the device is at or near the target treatment site).
Regarding claim 13, Bakos in view of Behzadian disclose all of the limitations of claim 1, as described above.
Bakos further discloses a camera configured to visualize at least one of an anatomy of the patient's head or the proximal electrode and the distal electrode ([0114]; the ablation device may be employed in conjunction with an endoscope the endoscope may comprise a camera comprising a CCD; it is the examiner position that the camera of the endoscope would be capable of viewing at least one of an anatomy of a patient’s head of the proximal electrode and the distal electrode when used in conjunction with the ablation device).
Regarding claim 15, Bakos in view of Behzadian disclose all of the limitations of claim 13, as described above.
Bakos further discloses the camera being selectively actuatable between a distal extended position and a proximal retracted position relative to the proximal electrode and the distal electrode for selectively visualizing the anatomy of the patient's head and the proximal electrode and the distal electrode, respectively ([0055] & [0114]; the ablation device may be employed in conjunction with an endoscope that comprises a camera; the electrodes 21 & 22 may be advanced to deploy and expose the electrodes beyond the distal end of sheath 40 and endoscope).
Regarding claim 21, Bakos in view of Behzadian disclose all of the limitations of claim 1, as described above.
Bakos further discloses the proximal electrode and the distal electrode having cage configurations ([0070]-[0071], [0081], [0088], [0117]; Figure 22—element 20).
Regarding claim 28, Bakos in view of Behzadian disclose all of the limitations of claim 1, as described above.
Bakos further discloses wherein: the distal electrode operate as an active electrode assembly, and the proximal electrode operates as a return electrode ([0060]; the proximal electrode 22 and the distal electrode 21 may be operated in a bipolar mode; wherein the distal electrode 21 may have a first polarity and the proximal electrode 22 may have a second opposite polarity).
Bakos does not disclose wherein: the distal tip and the distal electrode operate as an active electrode assembly.
Behzadian teaches wherein the proximal electrode operates as the return electrode and wherein: the distal tip and the distal electrode operate as an active electrode assembly ([0006], [0010], [0028], [0029], [0033], & [0037]; Figures 3C & 6—element 16, 20, & 22; the bipolar generator is configured to create dissimilar polarity between three or more electrodes such that the total surface area of the electrodes with a high voltage polarity is unequal to the total surface area of the electrodes having a return polarity; the polarity of the three electrodes may be altered individually to create different current densities).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the electrode distal tip and the active electrode assembly, as disclosed by Bakos, to include wherein both the distal tip and the distal electrode operate as the active electrode assembly, as taught by Behzadian, as both references and the claimed invention are directed toward ablation catheters comprising a plurality of electrodes configured to operate in a bipolar mode. As disclosed by Behzadian, the polarity of the three electrodes may be individually altered such that the distal tip and the distal electrode may operate as active electrodes while the proximal operates as a return electrode, this configuration creates dissimilar surface areas that allow for the current density and the electric field to be higher around the electrode with the return polarity, therefore resulting in lesion formation around the electrode with the return polarity ([0010], [0011], [0028], [0029], [0033]-[0034], & [0037]). 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 electrode distal tip and the active electrode assembly, as disclosed by Bakos, to include wherein both the distal tip and the proximal electrode operate as the active electrode assembly, as taught by Behzadian, as such a modification would allow for the ablation device to create dissimilar electrode surface areas in order control the current density and lesion formation in tissue.
Regarding claim 29 (first claim 29), as best understood in view of the 112(b) rejection, Bakos in view of Behzadian disclose all of the limitations of claim 1, as described above.
Bakos further discloses wherein: the proximal electrode operate as an active electrode assembly, and the distal electrode operates as a return electrode ([0060]; the proximal electrode 22 and the distal electrode 21 may be operated in a bipolar mode; wherein the distal electrode 21 may have a first polarity and the proximal electrode 22 may have a second opposite polarity).
Bakos does not disclose the distal tip and the proximal electrode operate as the active electrode assembly.
Behzadian teaches wherein the distal electrode operates as the return electrode and wherein: the distal tip and the proximal electrode operate as the active electrode assembly ([0006], [0010], [0028], & [0033]; Figures 3B—element 16, 20, & 22; the bipolar generator is configured to create dissimilar polarity between three or more electrodes such that the total surface area of the electrodes with a high voltage polarity is unequal to the total surface area of the electrodes having a return polarity; the polarity of the three electrodes may be altered individually to create different current densities).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the electrode distal tip and the active electrode assembly, as disclosed by Bakos, to include wherein both the distal tip and the proximal electrode operate as the active electrode assembly, as taught by Behzadian, as both references and the claimed invention are directed toward ablation catheters comprising a plurality of electrodes configured to operate in a bipolar mode. As disclosed by Behzadian, the polarity of the three electrodes may be individually altered such that the distal tip and one of the proximal electrode or distal electrode may operate as active electrodes while the other of the proximal electrode or distal electrode operates as a return electrode, this configuration creates dissimilar surface areas that allow for the current density and the electric field to be higher around the electrode with the return polarity, therefore resulting in lesion formation around the electrode with the return polarity ([0010], [0011], [0028], [0029], & [0033]-[0034]). 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 electrode distal tip and the active electrode assembly, as disclosed by Bakos, to include wherein both the distal tip and the proximal electrode operate as the active electrode assembly, as taught by Behzadian, as such a modification would allow for the ablation device to create dissimilar electrode surface areas in order control the current density and lesion formation in tissue.
Regarding claim 30 (second claim 29; see above objection), Bakos discloses a surgical instrument comprising: a sheath configured to be inserted into a cavity of a patient's head ([0054]; Figure 4—element 40); and an ablation catheter disposed within the sheath, the ablation catheter comprising (i) a shaft defining a longitudinal axis and terminating at a distal tip ([0054]-[0055], & [0064]-[0065]; Figures 1 & 4—elements 18 & 28; with the shaft being the elongate member 18 that comprises a distal tip 28, which may be retracted and deployed relative to the sheath 40, and the longitudinal axis being the longitudinal axis of the shaft 18), and (ii) a proximal electrode and a distal electrode disposed on the shaft ([0067] & [0068]; Figure 4—elements 22 & 21), the proximal electrode and the distal electrode being operable to deliver RF energy to tissue to thereby ablate the tissue ([0044] & [0060]), wherein (i) the distal tip operates as an electrode assembly ([0065]; Figure 4—element 28; the distal tip 28 may be configured to deliver electric current and may be an electrode) and one of the proximal electrode and the distal electrode operates as a return electrode assembly, and (ii) the other of the proximal electrode and the distal electrode operates as an active electrode ([0060]; the proximal electrode 22 and the distal electrode 21 may be operated in a bipolar mode; wherein the distal electrode 21 may have a first polarity and the proximal electrode 22 may have a second opposite polarity), the ablation catheter being selectively translatable relative to the sheath between a proximal retracted position in which the proximal electrode and the distal electrode are housed within the sheath to thereby prevent the proximal electrode and the distal electrode from radially expanding from a non-expanded state to an expanded state, and a distal extended position in which the proximal electrode and the distal electrode are exposed from the sheath to thereby permit the proximal electrode and the distal electrode to radially expand from the non-expanded state to the expanded state for contacting tissue ([0054]-[0055], [0061], [0064], & [0067]; Figures 1, 2, & 4—elements 22 & 21), the proximal electrode and the distal electrode each being selectively longitudinally translatable relative to each other along the shaft ([0067]; Figure 4—elements 22, 21, & “d”; the proximal electrode 22 and the distal electrode 21 may be slidably or theadably disposed on the elongate member/shaft 18 so that the distance “d” between the electrodes may be adjusted by advancing or rotating the electrodes relative to one another).
Bakos does not disclose the distal tip and the one of the proximal electrode and the distal electrode operates as the return electrode assembly.
Behzadian discloses an ablation catheter comprising a distal tip ([0027]; Figures 3A-3C & 6—element 22), a proximal electrode ([0027]; Figures 3A-3C & 6—element 16), and a distal electrode ([0027]; Figures 3A-3C & 6—element 20); wherein the distal tip and the one of the proximal electrode and the distal electrode operates as the return electrode assembly ([0006], [0010], [0027], & [0033]; Figures 3A & 6—element 16, 20, & 22; the bipolar generator is configured to create dissimilar polarity between three or more electrodes such that the total surface area of the electrodes with a high voltage polarity is unequal to the total surface area of the electrodes having a return polarity; the polarity of the three electrodes may be altered individually to create different current densities).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the electrode distal tip and the return electrode assembly, as disclosed by Bakos, to include wherein the distal tip and the one of the proximal electrode and the distal electrode operates as the return electrode assembly, as taught by Behzadian, as both references and the claimed invention are directed toward ablation catheters comprising a plurality of electrodes configured to operate in a bipolar mode. As disclosed by Behzadian, the polarity of the three electrodes may be individually altered such that the distal tip and one of the proximal electrode or distal electrode may operate as return electrodes while the other of the proximal electrode or distal electrode operates as an active electrode, this configuration creates dissimilar surface areas that allow for the current density and the electric field to be higher around the electrode with the active polarity, therefore resulting in lesion formation around the electrode with the active polarity ([0010], [0011], [0027], & [0033]-[0034]). 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 electrode distal tip and the return electrode assembly, as disclosed by Bakos, to include wherein the distal tip and the one of the proximal electrode and the distal electrode operates as the return electrode assembly, as taught by Behzadian, as such a modification would allow for the ablation device to create dissimilar electrode surface areas in order control the current density and lesion formation in tissue.
Regarding claim 31, (misnumbered claim 30; see above objection), as best understood in view of the 112(b) rejection, Bakos in view of Behzadian disclose all of the limitations of claim 30, as described above.
Bakos further discloses wherein: the proximal electrode operate as a return electrode assembly, and the distal electrode operates as an active electrode ([0060]; the proximal electrode 22 and the distal electrode 21 may be operated in a bipolar mode; wherein the distal electrode 21 may have a first polarity and the proximal electrode 22 may have a second opposite polarity).
Bakos does not disclose the distal tip and the proximal electrode operate as the return electrode assembly.
Behzadian further teaches wherein the distal electrode operates as an active electrode and the distal tip and the proximal electrode operate as the return electrode assembly ([0006], [0010], [0027], & [0033]; Figures 3A & 6—element 16, 20, & 22; the bipolar generator is configured to create dissimilar polarity between three or more electrodes such that the total surface area of the electrodes with a high voltage polarity is unequal to the total surface area of the electrodes having a return polarity; the polarity of the three electrodes may be altered individually to create different current densities around different 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 electrode distal tip and the return electrode assembly, as disclosed by Bakos, to include wherein both the distal tip and the proximal electrode operate as the return electrode assembly, as taught by Behzadian, as both references and the claimed invention are directed toward ablation catheters comprising a plurality of electrodes configured to operate in a bipolar mode. As disclosed by Behzadian, the polarity of the three electrodes may be individually altered such that the distal tip and the proximal electrode may operate as return electrodes while the distal electrode operates as an active electrode, this configuration creates dissimilar surface areas that allow for the current density and the electric field to be higher around the electrode with the active polarity, therefore resulting in lesion formation around the electrode with the active polarity ([0010], [0011], [0027], & [0033]-[0034]). 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 electrode distal tip and the return electrode assembly, as disclosed by Bakos, to include wherein both the distal tip and the proximal electrode operate as the return electrode assembly, as taught by Behzadian, as such a modification would allow for the ablation device to create dissimilar electrode surface areas in order control the current density and lesion formation in tissue.
Regarding claim 32 (mis-numbered claim 31), as best understood in view of the 112(b) rejection, Bakos in view of Behzadian disclose all of the limitations of claim 30, as described above.
Bakos further discloses wherein: the distal electrode operate as a return electrode assembly, and the proximal electrode operates as an active electrode ([0060]; the proximal electrode 22 and the distal electrode 21 may be operated in a bipolar mode; wherein the distal electrode 21 may have a first polarity and the proximal electrode 22 may have a second opposite polarity).
Bakos does not disclose wherein: the distal tip and the distal electrode operate as the return electrode assembly.
Behzadian further teaches wherein the proximal electrode operates as an active electrode and wherein: the distal tip and the distal electrode operate as the return electrode assembly ([0006], [0010], [0027], & [0033]; Figures 3A & 6—element 16, 20, & 22; the bipolar generator is configured to create dissimilar polarity between three or more electrodes such that the total surface area of the electrodes with a high voltage polarity is unequal to the total surface area of the electrodes having a return polarity; the polarity of the three electrodes may be altered individually to create different current densities around different 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 electrode distal tip and the return electrode assembly, as disclosed by Bakos, to include wherein both the distal tip and the distal electrode operate as the return electrode assembly, as taught by Behzadian, as both references and the claimed invention are directed toward ablation catheters comprising a plurality of electrodes configured to operate in a bipolar mode. As disclosed by Behzadian, the polarity of the three electrodes may be individually altered such that the distal tip and the distal electrode may operate as return electrodes while the proximal electrode operates as an active electrode, this configuration creates dissimilar surface areas that allow for the current density and the electric field to be higher around the electrode with the active polarity, therefore resulting in lesion formation around the electrode with the active polarity ([0010], [0011], [0027], & [0033]-[0034]). 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 electrode distal tip and the return electrode assembly, as disclosed by Bakos, to include wherein both the distal tip and the distal electrode operate as the return electrode assembly, as taught by Behzadian, as such a modification would allow for the ablation device to create dissimilar electrode surface areas in order control the current density and lesion formation in tissue.
Claims 14 & 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Bakos in view of Behzadian and Saadat et al. (previously presented-US 20170231474 A1), hereinafter “Saadat”.
Regarding claim 14, Bakos in view of Behzadian disclose all of the limitations of claim 13, as described above.
Bakos does not disclose the camera being fixed to a distal end of one of the sheath or the ablation catheter.
Saadat teaches an expandable ablation catheter ([0096]; Figure 14A & 14B—element 1408/1410), comprising a camera configured to visualize at least one of an anatomy of the patient's head or the ablation elements ([0016], [0021], [0096]; Figure 14A & 14B—element 1401), the camera being fixed to a distal end of one of the sheath or the ablation catheter ([0097]; Figure 14A & 14B—element 1406).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the endoscope and camera, as disclosed by Bakos, to include the camera being fixed to a distal end of one of the sheath or the ablation catheter, as taught by Saadat, as both references and the claimed invention are directed toward expandable ablation catheters comprising cameras. As disclosed by Bakos, the ablation device may be employed in conjunction with an endoscope comprising a camera ([0114]). As disclosed by Saadat, an imaging assembly including a camera may be disposed in the vicinity of and connected to the ablation device via a coupler, the coupler keeps the camera attached to the ablation device but still allows particular movement of the camera relative to the ablation device so as to maintain a desired viewing angle or position with respect to the ablation device, the arrangement of the imaging assembly relative to the ablation device may aid in visualization and limit the invasiveness of using the device ([0021], [0025], & [0097]). 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 ablation device and the camera, as disclosed by Collins, to include the camera being fixed to a distal end of one of the sheath or the ablation catheter, as taught by Saadat, as such a modification would provide for a camera arrangement relative to the ablation device may aid in visualization and limit the invasiveness of using the device.
Regarding claim 22, Bakos in view of Behzadian disclose all of the limitations of claim 13, as described above.
Bakos does not disclose the camera being fixed to the shaft in a position proximal to the proximal electrode and the distal electrode.
Saadat teaches an expandable ablation catheter ([0096]; Figure 14A & 14B—element 1408/1410), comprising a camera configured to visualize at least one of an anatomy of the patient's head or the ablation elements ([0016], [0021], [0096]; Figure 14A & 14B—element 1401), the camera being fixed to the shaft in a position proximal to the ablation element ([0025, [0089], & [0097]; Figure 14A & 14B—element 1406).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the endoscope and camera, as disclosed by Bakos, to include the camera being fixed to the shaft in a position proximal to the ablation element, as taught by Saadat, as both references and the claimed invention are directed toward expandable ablation catheters comprising cameras. As disclosed by Bakos, the ablation device may be employed in conjunction with an endoscope comprising a camera ([0114]). As disclosed by Saadat, an imaging assembly including a camera may be connected to the ablation device via a coupler and disposed proximally from the ablation element, the coupler keeps the camera attached to the ablation device but still allows particular movement of the camera relative to the ablation device so as to maintain a desired viewing angle or position with respect to the ablation device, the arrangement of the imaging assembly relative to the ablation device may aid in visualization, limit the invasiveness of using the device, and minimize engagement with target tissue ([0021], [0025], [0097], & [0102]). 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 ablation device and the camera, as disclosed by Collins, to include the camera being fixed to the shaft in a position proximal to the ablation element, as taught by Saadat, as such a modification would provide for a camera arrangement relative to the ablation device may aid in visualization, limit the invasiveness of using the device, and minimize the camera’s engagement with tissue.
Regarding claim 23, Bakos in view of Behzadian and Saadat disclose all of the limitations of claim 22, as described above.
Bakos does not disclose the camera configured to extend radially beyond the proximal electrode and the distal electrode in the expanded state.
Saadat further teaches the camera configured to extend radially beyond the ablation element in the expanded state ([0016], [0027], [0096], & [0099]; Figure 14A & 14B—element 1404 & 1410; the imaging assembly is configured to be axially translated).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the endoscope and camera, as disclosed by Bakos, to include the camera configured to extend radially beyond the ablation element in the expanded state, as further taught by Saadat, as both references and the claimed invention are directed toward expandable ablation catheters comprising cameras. As disclosed by Bakos, the ablation device may be employed in conjunction with an endoscope comprising a camera ([0114]). As disclosed by Saadat, an imaging assembly including a camera may be connected to the ablation device via a coupler and disposed proximally from the ablation element, the coupler keeps the camera attached to the ablation device but still allows the imaging assembly to be axially translated to adjust the distance relative to the ablation element to a desired viewing position, the arrangement of the imaging assembly relative to the ablation device may aid in visualization, limit the invasiveness of using the device, and minimize engagement with target tissue ([0021],[0023], [0025], [0033], [0097], & [0099]). 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 endoscope and camera, as disclosed by Bakos, to include the camera configured to extend radially beyond the ablation element in the expanded state, as further taught by Saadat, as such a modification would provide for a camera arrangement relative to the ablation device may aid in visualization, limit the invasiveness of using the device, and allows for the imaging assembly to be axially translated to achieve a desired viewing position.
Regarding claim 24, Bakos in view of Behzadian and Saadat disclose all of the limitations of claim 15, as described above.
Bakos does not disclose the camera in the proximal position being configured to extend radially beyond the proximal electrode and the distal electrode in the expanded state for visualizing the anatomy of the patient's head.
Saadat teaches an expandable ablation catheter ([0096]; Figure 14A & 14B—element 1408/1410), comprising a translatable camera configured to visualize at least one of an anatomy of the patient's head or the ablation elements ([0016], [0021], [0096]; Figure 14A & 14B—element 1401); the camera in the proximal position being configured to extend radially beyond the ablation element in the expanded state for visualizing the anatomy of the patient's head ([0016], [0021], [0094], [0099]; Figure 14A & 14B—element 1404 & 1410; the imaging assembly is configured to be axially and vertically translated).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the endoscope and camera, as disclosed by Bakos, to include the camera in the proximal position being configured to extend radially beyond the ablation element in the expanded state for visualizing the anatomy of the patient's head, as taught by Saadat, as both references and the claimed invention are directed toward expandable ablation catheters comprising cameras. As disclosed by Bakos, the ablation device may be employed in conjunction with an endoscope comprising a camera ([0114]). As disclosed by Saadat, an imaging assembly including a camera may be connected to the ablation device via a coupler, the imaging assembly is configured to be axially and laterally translated to adjust the distance and height relative to the ablation element to a desired viewing position, the arrangement of the imaging assembly relative to the ablation device may aid in visualization, limit the invasiveness of using the device, and minimize engagement with target tissue ([0021],[0023], [0025], [0033], [0097], & [0099]). 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 endoscope and camera, as disclosed by Bakos, to include the camera in the proximal position being configured to extend radially beyond the ablation element in the expanded state for visualizing the anatomy of the patient's head, as further taught by Saadat, as such a modification would provide for a camera arrangement relative to the ablation device may aid in visualization, limit the invasiveness of using the device, and allows for the imaging assembly to be axially vertically translated to achieve a desired viewing position.
Conclusion
Accordingly, claims 1, 4-6, 8, 10-15, 21-24, & 28-32 are rejected.
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.
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/M.D.T./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794