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 .
A complete action on the merits of pending claims 1-35 appears herein.
Response to Arguments
Applicant’s arguments, see Remarks, filed 01/07/2026, with respect to the rejection(s) of claim(s) 1 under U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Reinders (US 9,198,592 B2) in view of Sinelnikov (US 2016/0374710 A1) in view of Vaska (US 2003/0028187 A1).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-27, and 33-35 are rejected under 35 U.S.C. 103 as being unpatentable over Reinders (US 9,198,592 B2) in view of Sinelnikov (US 2016/0374710 A1) in view of Vaska (US 2003/0028187 A1).
Regarding claims 1 and 35, Reinders teaches
an input-output device system; (Fig. 3A, Char. 320: input-output device system)
a memory device system (Fig. 3A, Char. 330: memory device system) comprising a non-transitory computer-readable storage medium (Col. 8, Line 65 – Col. 9, Line 3) and storing a program; (Col. 18, Line 65 – Col. 19, Line 3) and
a data processing device system (Fig. 3A, Char. 310: data processing device system) communicatively connected to the input-output device system and the memory device system, (Col. 18, Line 54 – Col. 19, Line 28) the data processing device system configured at least by the program at least to:
receive, via the input-output device system, location information (Col. 16, Lines 37-43: the sensed physical characteristic) indicating a plurality of locations in a bodily cavity (Col. 16, Lines 37-43: the sensed physical characteristics are used to determine surrounding tissues, such as valves/ostias) in response to movement of at least part of a transducer-based device in the bodily cavity; (Col. 16, Lines 37-43: The device would be moved into the sensed area)
determine, based at least on an analysis of at least part of the location information, target location information (Col. 16, Lines 37-43: the determined position/orientation of surrounding tissue relative to the device) indicative of a target location set relative to a first particular location of the plurality of locations in the bodily cavity; (Fig. 9 and Col. 56, Line 54 – Col. 57, Line 11 and Col. 16, Lines 46-49: the selected identified regions for ablation surrounding the bodily openings, ports or pulmonary vein ostia)
cause the transducer-based device to deliver particular tissue-ablative energy via a communicative connection between the input-output device system and the transducer-based device; (Fig. 9 and Col. 58, Lines 38-47)
Reinders, as applied to claim 1 above, is silent regarding the data processing device being configured to determine, based at least on an analysis of at least part of the location information, that at least a portion of the transducer-based device has reached a target location relative to the first particular location of the plurality of locations in the bodily cavity, the first particular location being a previous location of the part of the transducer-based device, and the target location defined at least in part by the target location information and belonging to the target location set; and that the ablation is in in response to the determination that at least the portion of the transducer-based device has reached the target location relative to the first particular location of the plurality of locations in the bodily cavity.
Sinelnikov, in a similar field of endeavor, teaches a transducer-based ablation system configured to determine, based at least on an analysis of at least of sensed physical characteristics of tissue, (nerve stimulation) that at least a portion of a transducer-based ablation device has reached an identified region for ablation relative to a first particular location of a plurality of locations in a bodily cavity, (Par. [0229]: an ultrasound signal that mechanically or thermally stimulates a nerve may be delivered without ablating tissue to confirm effective or safe aim of an ablation transducer prior to delivery of ablation energy) the identified region for ablation defined at least in part by the position/orientation of surrounding tissue relative to the device and belonging to the target location set; (the tissue/region targeted for ablation would be at least partially defined by the tissue surrounding said targeted tissue/region) and
cause, in response to the determination that at least the portion of the transducer-based device has reached the target location relative to the first particular location of the plurality of locations in the bodily cavity, the transducer-based device to deliver particular tissue-ablative energy. (Par. [0229]: Upon confirmation that the ablation transducer is properly aimed at a target tissue, said target tissue would be ablated via said ablation transducer)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Reinders, as applied to claim 1 above, to incorporate the teachings of Sinelnikov, and configure the system of Reinders to perform the position confirmation process of Sinelnikov. Doing so would minimize the risk of delivering ablative energy to tissue other than the target tissues designated for ablation.
The combination of Reinders/Sinelnikov, as applied to claim 1 above, is silent regarding the first particular location being a previous location of the part of the transducer-based device.
Vaska, in a similar field of endeavor, teaches an ablation device configured to locate previously formed ablation lesions so that subsequent lesions will merge with previously formed lesions to create a continuous lesion. (Par. [0020])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Reinders/Sinelnikov, as applied to claim 1 above, to incorporate the teachings of Vaska, and determine the target location based on a first particular location being a previously ablated location of the part of the transducer-based device. Doing so would allow for the device to easily for larger continuous ablation patterns, as suggested in Vaska. (Par. [0020])
Regarding method claim 34, the claim is rejected by the same or substantially the same rationale as applied to the rejection of apparatus claim 1, since operation of the prior art relied on to reject apparatus claim 34 would naturally result in the step of method claim 1 being satisfied.
Regarding claim 2, the combination of Reinders/Sinelnikov/Vaska, as applied to claim 1 above, teaches the data processing device system is configured at least by the program at least to determine, as at least part of the determination that at least the portion of the transducer-based device has reached the target location relative to the first particular location of the plurality of locations in the bodily cavity, that at least the portion of the transducer-based device has reached a target distance from the first particular location of the plurality of locations in the bodily cavity. (Vaska: Par. [0020]: The target distance would be a maximum distance required to form a continuous lesion with the previously ablated location – it is implicit that this feature be present in the Reinders/Sinelnikov/Vaska combination based on the rejection to claim 1 above.)
Regarding claim 4, the combination of Reinders/Sinelnikov/Vaska, as applied to claim 2 above, teaches the target location is a second particular location of the plurality of particular locations in the bodily cavity spaced by at least the target distance (the distance required to form a continuous lesion) from the first particular location of the plurality of locations in the bodily cavity. (Reinders: Fig. 9 and Col. 56, Line 54 – Col. 57, Line 11 and Col. 16, Lines 46-49 and Vaska: Par. [0020] – it is implicit that this feature be present in the Reinders/Sinelnikov/Vaska combination based on the rejection to claim 1 above.)
Regarding claim 5, the combination of Reinders/Sinelnikov/Vaska, as applied to claim 2 above, teaches the data processing device system is configured at least by the program at least to determine the target location as a second particular location of the plurality of locations in the bodily cavity in response to the determination that at least the portion of the transducer-based device has reached the target distance from the first particular location of the plurality of locations in the bodily cavity. (Reinders: Col. 48, Lines 43-48; and Vaska: Par. [0020] – it is implicit that this feature be present in the Reinders/Sinelnikov/Vaska combination based on the rejection to claim 1 above.)
Regarding claim 3, the combination of Reinders/Sinelnikov/Vaska, as applied to claim 1 above, teaches the target location information defines a target distance from the first particular location of the plurality of locations in the bodily cavity. (Vaska: Par. [0020]: In the event that a large continuous lesion is desired, the next tissue area to be ablated would define a maximum distance from the previously ablated first particular location required to form a single continuous lesion – it is implicit that this feature be present in the Reinders/Sinelnikov/Vaska combination based on the rejection to claim 1 above.)
Regarding claim 6, the combination of Reinders/Sinelnikov/Vaska, as applied to claim 1 above, teaches the portion of the transducer-based device that is determined to have reached the target location relative to the first particular location is the part of the transducer-based device that has moved. (the portion/part of the transducer-based device comprising transducers)
Regarding claim 7, the combination of Reinders/Sinelnikov/Vaska, as applied to claim 1 above, teaches the target location information (the determined position/orientation of surrounding tissue relative to the device) defines the target location set (the selected identified regions for ablation surrounding the bodily openings, ports or pulmonary vein ostia) as a plurality of possible target locations, each of the possible target locations spaced from the first particular location of the plurality of locations in the bodily cavity by a target radius. (Reinders: Col. 57, Lines 1-11; and Vaska: Par. [0020] – it is implicit that this feature be present in the Reinders/Sinelnikov/Vaska combination based on the rejection to claim 1 above.)
Regarding claim 8, the combination of Reinders/Sinelnikov/Vaska, as applied to claim 1 above, teaches the data processing device system is configured at least by the program at least to determine, as at least part of the determination that at least the portion of the transducer-based device has reached the target location relative to the first particular location of the plurality of locations in the bodily cavity, a presence of contact between the transducer-based device and a tissue surface in the bodily cavity. (Reinders: Col. 48, Lines 43-48)
Regarding claim 9, the combination of Reinders/Sinelnikov/Vaska, as applied to claim 8 above, teaches the data processing device system is configured at least by the program at least to cause the transducer-based device to deliver the particular tissue-ablative energy also in response to determining the presence of the contact between the transducer-based device and the tissue surface in the bodily cavity. (Reinders: Col. 48, Lines 43-48)
Regarding claim 10, the combination of Reinders/Sinelnikov/Vaska, as applied to claim 1 above, teaches the first particular location of the plurality of locations is a location of a previously ablated tissue region. (Vaska: Par. [0020] – it is implicit that this feature be present in the Reinders/Sinelnikov/Vaska combination based on the rejection to claim 1 above.)
Regarding claims 11 and 12, the combination of Reinders/Sinelnikov/Vaska, as applied to claim 1 above, teaches the first particular location is one of the plurality of locations in the bodily cavity corresponding to a previous delivery of tissue ablation energy by the portion of the transducer-based device prior to delivery of the particular tissue-ablative energy. (Vaska: Par. [0020] – it is implicit that this feature be present in the Reinders/Sinelnikov/Vaska combination based on the rejection to claim 1 above.)
Regarding claims 13 and 14, the combination of Reinders/Sinelnikov/Vaska, as applied to claim 1 above, teaches the data processing device system is configured at least by the program at least to determine that at least the portion of the transducer-based device has reached a target distance from a location of at least the part of the transducer- based device during a previous delivery of tissue ablation energy; wherein the portion of the transducer-based device is the part of the transducer-based device. (Vaska: Par. [0020]: In the event that a large continuous lesion is desired, there would have to be a distance range or a maximum distance from the previously ablated first particular location required to form a single continuous lesion – it is implicit that this feature be present in the Reinders/Sinelnikov/Vaska combination based on the rejection to claim 1 above.)
Regarding claim 15, the combination of Reinders/Sinelnikov/Vaska, as applied to claim 1 above, teaches the target location (Reinders: Fig. 9 and Col. 56, Line 54 – Col. 57, Line 11 and Col. 16, Lines 46-49: the selected identified regions for ablation surrounding the bodily openings, ports or pulmonary vein ostia) is a second particular location of the plurality of locations in the bodily cavity, the second particular location other than the first particular location. (Vaska: Par. [0020] – it is implicit that this feature be present in the Reinders/Sinelnikov/Vaska combination based on the rejection to claim 1 above.)
Regarding claim 16, the combination of Reinders/Sinelnikov/Vaska, as applied to claim 1 above, teaches the data processing device system is configured at least by the program at least to cause the transducer-based device to deliver the particular tissue-ablative energy at the target location in response to determining that at least the portion of the transducer-based device has reached the target location. (Sinelnikov: Par. [0229]: an ultrasound signal that mechanically or thermally stimulates a nerve may be delivered without ablating tissue to confirm effective or safe aim of an ablation transducer prior to delivery of ablation energy – it is implicit that this feature be present in the Reinders/Sinenlikov/Vaska combination based on the rejection to claim 1 above.)
Regarding claim 17, the combination of Reinders/Sinelnikov/Vaska, as applied to claim 1 above, is silent regarding the data processing device system is configured at least by the program at least to cause the transducer-based device to deliver the particular tissue-ablative energy via a discrete energy application set.
Sinelnikov, in a similar field of endeavor, teaches delivering a discrete energy application set. (Par. [0249])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Reinders/Sinelnikov/Vaska, as applied to claim 1 above, to further incorporate the teachings of Sinenlikov, and configure the data processing device system at least by the program at least to cause the transducer-based device to deliver the particular tissue-ablative energy via a discrete energy application set. Doing so would be a simple substitution of one set of energy parameters for another for the predictable result of delivery ablative energy to a target tissue to treat conditions such as atrial fibrillation.
Regarding claim 18, the combination of Reinders/Sinelnikov/Vaska, as applied to claim 17 above, teaches the discrete energy application set is configured to cause pulsed field ablation of tissue. (Sinelnikov: Par. [0151]: the carotid body and other desired target structures may be ablated using pulsed wave ultrasound – it is implicit that this feature be present in the Reinders/Sinenlikov/Vaska combination based on the rejection to claim 17 above.)
Regarding claim 19, the combination of Reinders/Sinelnikov/Vaska, as applied to claim 17 above, teaches the portion of the transducer-based device is a first portion of the transducer-based device, wherein the target location is a first target location, (Reinders: Fig. 9 and Col. 56, Line 54 – Col. 57, Line 11 and Col. 16, Lines 46-49: A portion of tissue in the ablation pattern contacting a first ablative transducer) and the discrete energy application set is a first discrete energy application set, (the ablative energy emitted from the first ablative transducer) and wherein the data processing device system is configured at least by the program at least to: determine, after at least the first portion of the transducer-based device has reached the first target location, and based at least on an analysis of at least part of the location information, that at least a second portion of the transducer-based device has reached a second target location relative to the first target location; (Sinelnikov: Par. [0229]: an ultrasound signal that mechanically or thermally stimulates a nerve may be delivered without ablating tissue to confirm effective or safe aim of an ablation transducer prior to delivery of ablation energy; The effective/safe aim determination would occur for all ablation transducers – it is implicit that this feature be present in the Reinders/Sinenlikov/Vaska combination based on the rejection to claim 1 above.) and cause, in response to determining that at least the second portion of the transducer-based device has reached the second target location relative to the first target location, the transducer- based device to deliver a second discrete energy application set via the communicative connection between the input-output device system and the transducer-based device. (Sinelnikov: Par. [0229]: Upon confirmation that the ablation transducer is properly aimed at a target tissue, said target tissue would be ablated via said ablation transducer – it is implicit that this feature be present in the Reinders/Sinenlikov/Vaska combination based on the rejection to claim 1 above.)
Regarding claims 20 and 21, the combination of Reinders/Sinelnikov/Vaska, as applied to claim 19 above, teaches wherein the second portion of the transducer- based device is the first portion of the transducer-based device, wherein the part of the transducer-based device is the second portion of the transducer-based device, which also is the first portion of the transducer-based device. (Reinders: Fig. 2)
Regarding claim 22, the combination of Reinders/Sinelnikov/Vaska, as applied to claim 19 above, teaches the data processing device system is configured at least by the program at least to: cause the transducer-based device to deliver the first discrete energy application set at the first target location in response to determining that at least the first portion of the transducer- based device has reached the first target location, and wherein the data processing device system is configured at least by the program at least to cause the transducer-based device to deliver the second discrete energy application set at the second target location in response to determining that at least the second portion of the transducer-based device has reached the second target location. (Sinelnikov: Par. [0229]: an ultrasound signal that mechanically or thermally stimulates a nerve may be delivered without ablating tissue to confirm effective or safe aim of an ablation transducer prior to delivery of ablation energy – it is implicit that this feature be present in the Reinders/Sinenlikov/Vaska combination based on the rejection to claim 1 above; The effective/safe aim determination would occur for all ablation transducers and the discrete energy delivery would occur after safe/effective aim is confirmed/ensured.)
Regarding claim 23, the combination of Reinders/Sinelnikov/Vaska, as applied to claim 19 above, teaches the data processing device system is configured at least by the program at least to cause the transducer-based device to deliver the first discrete energy application set during a first time interval, and to cause the transducer-based device to deliver the second discrete energy application set during a second time interval, (Reinders: Fig. 9 and Col. 58, Lines 38-47: The ablative energy delivered to tissue via the ablative transducers of Reinders would be delivered for a duration for each transducer, including at least a first and second duration for a respective first and second transducer) a duration of the second time interval being the same as a duration of the first time interval. (Absent a statement otherwise, one of ordinary skill in the art would assume the first and second durations to be the same)
Regarding claims 24 and 26, the combination of Reinders/Sinelnikov/Vaska, as applied to claim 19 above, teaches the first discrete energy application set includes one or more discrete energy applications, each delivering a first particular amount of energy, and the second discrete energy application set includes one or more discrete energy applications, each delivering a second particular amount of energy. (In the combination of Reinders/Sinelnikov/Vaska, as applied to claim 19 above, each transducer of Reinders would output a discrete energy application set with its own particular amount of energy.)
The combination of Reinders/Sinelnikov/Vaska, as applied to claim 19 above, is silent regarding the first discrete energy application set includes a different total number of discrete energy applications than the second discrete energy application set; and the second particular amount of energy different than the first particular amount of energy.
However, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified/controlled the duration/amount of ablative energy being delivered to the treated tissue for each transducer, such that the desired ablation pattern is achieved. (e.g. to compensate for differences in target ablation depth along the pattern or differing tissue characteristics for tissues contacting different transducers (thickness, composition, etc.))
Regarding claim 25, the combination of Reinders/Sinelnikov/Vaska, as applied to claim 19 above, teaches the first discrete energy application set includes one or more discrete energy applications, each delivering a first particular amount of energy, and the second discrete energy application set includes one or more discrete energy applications, each delivering a second particular amount of energy, (Reinders: Fig. 9 and Col. 58, Lines 38-47: The ablative energy delivered to tissue via the ablative transducers of Reinders would be delivered with an amount of energy, including at least a first and second amount of energy for a respective first and second transducer) the second particular amount of energy the same as the first particular amount of energy. (Absent a statement otherwise, one of ordinary skill in the art would assume the first and second amounts of energy delivered via a first and second transducer to be the same)
Regarding claim 27, the combination of Reinders/Sinelnikov/Vaska, as applied to claim 19 above, teaches each of the first discrete energy application set and the second discrete energy application set includes one or more respective particular discrete energy applications, (Reinders: Fig. 9 and Col. 58, Lines 38-47: The ablative energy delivered to tissue via the ablative transducers of Reinders would be delivered with an amount of energy, including at least a first and second amount of energy for a respective first and second transducer) the one or more respective particular discrete energy applications of the first discrete energy application set and the one or more respective particular discrete energy applications of the second discrete energy application set applied in an overlapping manner. (Reinders: Fig. 9 and Col. 56, Line 54 – Col. 57, Line 11 and Col. 16, Lines 46-49: There would be at least some overlap in energy delivery between the border of the ablation pattern created by the transducer delivering the first discrete energy application and the ablation pattern created by the transducer delivering the second discrete ablation pattern to form a continuous lesion)
Regarding claim 33, the combination of Reinders/Sinelnikov/Vaska, as applied to claim 1 above, teaches the particular tissue-ablative energy is energy delivered via pulsed field ablation.
Sinelnikov further teaches delivering ablative ultrasound energy in either a pulsed wave or continuous application. (Par. [0152])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Reinders/Sinelnikov/Vaska, as applied to claim 1 above, to further incorporate the teachings of Sinelnikov, and configure the particular tissue-ablative energy is energy delivered via pulsed field ablation or continuous application. Doing so would grant a user more control over energy delivery and provide more treatment/energy delivery options to said user.
Allowable Subject Matter
Claims 28-32 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
The following is a statement of reasons for the indication of allowable subject matter:
The prior art of record fails to explicitly teach all of the limitations of claim 27, and further teach “wherein each of the first discrete energy application set and the second discrete energy application set forms a respective part of a group of discrete energy application sets, each discrete energy application set in the group of discrete energy application sets configured to deliver a respective amount of energy insufficient to produce a transmural tissue lesion in the bodily cavity, and wherein the discrete energy application sets in the group of the discrete energy application sets are configured to collectively deliver energy sufficient to produce a transmural tissue lesion in the bodily cavity” of claim 28. Claims 29-32 would be allowable due to their respective dependencies on claim 28.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/N.S.B./Examiner, Art Unit 3794
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