DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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.
Claim 16 is 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 16 recites the limitation "a first electrode" in line 3. The antecedent basis for this limitation is confusing, since it’s unclear how/whether it is related to the previously-recited ‘electrodes’. Appropriate correction is required.
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(s) 1-7, 11, 12, 14, and 17-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Koop, U.S. 2022/0022952 (hereinafter Koop).
Regarding claim 1, Koop discloses (note paragraph 87; fig. 3B) an irreversible electroporation (IRE) system, the IRE system comprising: processing circuitry configured to: select a first set of electrodes positioned to produce a first electric field in a first direction in a region of tissue of a patient; select a second set of electrodes positioned to produce a second electric field in a second direction in the region of tissue; and transmit a first IRE pulse to at least one electrode of the first set of electrodes to cause the at least one electrode of the first set of electrodes to produce the first electric field and transmit a second IRE pulse to at least one electrode of the second set of electrodes to cause the at least one electrode of the second set of electrodes to produce the second electric field, wherein the first IRE pulse and the second IRE pulse are transmitted by the processing circuitry to necessarily control an electric field gradient along a path within the region of tissue.
Regarding claim 2, Koop discloses (note paragraph 87; fig. 3B) an IRE system wherein the first IRE pulse is different than the second IRE pulse such that the first electric field has a different ‘level of strength’ than the second electric field (e.g., at different locations due to different field orientations).
Regarding claim 3, Koop discloses (see above) an IRE system wherein the processing circuitry is further configured to: transmit a non-IRE test pulse (note paragraph 102) to at least one of the group consisting of the first set of electrodes, the second set of electrodes, and a third set of electrodes to cause the at least one of the group consisting of the first set of electrodes, the second set of electrodes, and the third set of electrodes to generate a third electric field (note paragraph 76); receive, from at least one of the group consisting of the first set of electrodes, the second set of electrodes, the third set of electrodes, and a fourth set of electrodes, electrical signals indicative of the third electric field (note paragraphs 67-68); and map electrical activity within the region of tissue based on the electrical signals indicative of the third electric field (note paragraphs 67-68).
Regarding claim 4, Koop discloses (see above) an IRE system wherein at least one electrode of the at least one of the group consisting of the first set of electrodes, the second set of electrodes, the third set of electrodes, and the fourth set of electrodes is capable of being located external to the patient. It should be noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 5, Koop discloses (see above) an IRE system wherein the processing circuitry is configured to transmit the non-IRE test pulse, receive the electrical signals, and map the electrical activity at one or both of a time before and a time after an ablation procedure is performed on at least part of the region of tissue (note paragraphs 102 and 67).
Regarding claim 6, Koop discloses (see above) an IRE system further comprising a graphical user interface that includes a video display configured to receive and display a map of the electrical activity within the region of tissue onto a rendering of a patient anatomy that includes the region of tissue (note paragraph 68).
Regarding claim 7, Koop discloses (see above) an IRE system wherein a first catheter includes the first set of electrodes and the second set of electrodes (note fig. 2A).
Regarding claim 11, Koop discloses (see above) an IRE system wherein the processing circuitry is configured to control the first IRE pulse and the second IRE pulse to cause the electric field gradient to reach a target electric field gradient, wherein the target electric field gradient corresponds to an electric field strength above a threshold throughout the region of tissue (note paragraph 99).
Regarding claim 12, Koop discloses (see above) an IRE system wherein the first direction, the second direction, or both the first direction and the second direction are capable of being selected to align with a polarization direction associated with polarizable cells of the region of tissue. It should be noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 14, Koop discloses (note abstract and paragraph 87; fig. 3B) an irreversible electroporation (IRE) system, the IRE system comprising: processing circuitry configured to: select a first set of electrodes positioned in a first area in proximity to a target region of tissue to be ablated; select a second set of electrodes distributed over a second area; determine a first IRE pulse to be applied to at least one electrode of the first set of electrodes to ablate the target region of tissue in proximity to the first set of electrodes at least partially using a first electric field emitted by the at least one electrode of the first set of electrodes; determine a second IRE pulse to be applied to at least one electrode of the second set of electrodes to cause the at least one electrode of the second set of electrodes to emit a second electric field to interact with the first electric field in ablating the target region of tissue; and selectively apply the first IRE pulse to the at least one electrode of the first set of electrodes and the second IRE pulse to the at least one electrode of the second set of electrodes.
Regarding claim 17, Koop discloses (see above) an IRE system wherein the processing circuitry is further configured to determine a target electric field gradient to provide an electric field strength above a threshold throughout a specified volume of the target region of tissue; and wherein the processing circuitry is configured to select the first set of electrodes and the second set of electrodes and selectively apply the first IRE pulse and the second IRE pulse to cause an electric field gradient throughout the specified volume of the target region of tissue to reach the target electric field gradient (note paragraph 99).
Regarding claim 18, Koop discloses (see above) an IRE system wherein the at least one electrode of the second set of electrodes is capable of being positioned with respect to a position of the at least one electrode of the first set of electrodes in order to produce a combined electric field in a direction aligned with a polarization direction associated with polarizable cells of the target region of tissue, wherein the combined electric field is produced by a combination of the first electric field and the second electric field. It should be noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 19, Koop discloses (see above) an IRE system wherein the processing circuitry is further configured to: transmit a non-IRE test pulse (note paragraph 102) to at least one of the group consisting of the first set of electrodes, the second set of electrodes, and a third set of electrodes (note paragraph 76); receive electrical signals responsive to the non-IRE test pulse from at least one of the group consisting of the first set of electrodes, the second set of electrodes, the third set of electrodes, and a fourth set of electrodes (note paragraphs 67-68); and map the electrical signals onto a rendering of a patient anatomy that includes the target region of tissue that is displayable on a video monitor (note paragraphs 67-68).
Regarding claim 20, Koop discloses (see above) an IRE system wherein the processing circuitry is configured to transmit the non-IRE test pulse, and receive and map the electrical signals, after the target region of tissue is at least partially ablated (note paragraphs 102 and 67-68).
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.
Claim(s) 8-10 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Koop in view of Neal, U.S. 2018/0071014 (hereinafter Neal).
Regarding claims 8-10 and 13, Koop discloses (see above) an IRE system comprising a catheter having multiple sets of electrodes thereon. However, Koop fails to explicitly disclose a system comprising other electrode/catheter configurations, such as a multi-catheter configuration wherein each catheter has a respective set of electrodes thereon, or a configuration comprising a first catheter with a set of electrodes thereon and an external second set of electrodes. Neal teaches a similar IRE system comprising a variety of different electrode/catheter configurations, including: a single catheter configuration having electrodes thereon that communicate with each other, a multi-catheter configuration having electrodes thereon that communicate between the catheters, and a configuration comprising a catheter having electrodes thereon that communicate with an external electrode (note paragraph 60). It is well known in the art that these different electrode/catheter configurations are widely considered to be interchangeable (as can be seen by Neal). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have modified the system of Koop to comprise any of the electrode/catheter configurations taught by Neal. This is because this modification would have merely comprised a simple substitution of interchangeable electrode/catheter configurations in order to produce a predictable result (see MPEP 2143). Regarding claims 9 and 10, Koop in view of Neal teaches a system that would have been capable of performing the claimed function. It should be noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Claim(s) 15 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Koop in view of Rick, U.S. 2007/0167942 (hereinafter Rick).
Regarding claims 15 and 16, Koop discloses (see above) an IRE system comprising processing circuitry that is configured to control/adjust the electrodes based on feedback. However, Koop fails to explicitly disclose processing circuitry that is configured to adjust electrode impedance based on desired current in order to avoid an overcurrent condition. Rick teaches (note abstract) a similar system comprising processing circuitry that is configured to adjust electrode impedance based on desired current in order to avoid an overcurrent condition (note paragraphs 23-25). This design is utilized in order to maintain a low current density (see above), thereby resulting in increased safety. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have modified the system of Koop to comprise processing circuitry that is configured to adjust electrode impedance based on desired current, in order to avoid an overcurrent condition and increase safety.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS ANTHONY GIULIANI whose telephone number is (571)270-3202. The examiner can normally be reached Mon - Fri 9:00-5:00.
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/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794