DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Status of the Claims
The current office action is made responsive to claims filed 11/10/2025.
Acknowledgement is made to the cancellation of claims 1-12.
Any claims listed above as cancelled have sufficiently overcome any rejections set forth in any of the prior office actions.
Any claims listed above as withdrawn have been withdrawn from further consideration by the examiner, as these claims are drawn to a non-elected invention.
Claims 13-29 are pending. A complete action on the merits appears below.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 13-15, 17-19, 22, and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Demarais (US 20070135875 A1).
Regarding claim 13, Demarais teaches a method for ablation of a target tissue area ([0028]- [0029]), comprising:
inserting a catheter ([0038]) comprising at its distal end at least one positioning element ([0049]- [0051], [0074]- [0075]), at least one port ([0074]) proximate the at least one positioning element configured to deliver thermal energy, and at least one electrode ([0074]) proximate the at least one positioning element configured to generate an electric field to cause electroporation;
deploying the distal end proximate the target tissue area ([0075]);
applying a combination of thermal energy from the at least one port and an electrical field from the at least one electrode ([0046]).
Regarding claim 14, Demarais teaches the method of claim 13, wherein thermal energy is applied before applying the electrical field ([0038]).
Regarding claim 15, Demarais teaches the method of claim 13, wherein thermal energy is applied at the same time that the electrical field is applied ([0051], [0061], [0073]).
Regarding claim 17, Demarais teaches the method of claim 13, wherein a temperature of the target tissue area is raised to greater than 40°C for more than 1 second ([0029]- [0031], [0092]).
Regarding claim 18, Demarais teaches the method of claim 13, wherein a temperature of the target tissue area is raised to greater than 40°C and less than 1000C for more than 1 second ([0029]- [0031], [0092]).
Regarding claim 19, Demarais teaches the method of claim 13, wherein a temperature of the target tissue area is lowered to less than 25°C and greater than -200°C for more than 1 second ([0029]- [0031], [0092]).
Regarding claim 22, Demarais teaches the method of claim 13, wherein thermal energy is applied for a duration between 1 second and 30 minutes ([0031]).
Regarding claim 25, Demarais teaches the method of claim 13, wherein a temperature of the target tissue area is altered within five minutes of applying the electrical field ([0031], [0033]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Demarais (US 20070135875 A1) in view of Kadamus (US 20170007324 A1).
Regarding claim 16, Demarais teaches the method of claim 13.
However, Demarais fails to specifically teach the method wherein thermal energy is applied after applying the electrical field.
Kadamus teaches a known system and method for ablating patient tissue (Abstract, [0008]).
Kadamus further teaches providing a tissue neutralizing fluid such as warming or cooling fluid after providing ablation ([0165]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the use of tissue neutralizing fluids, as is taught by Kadamus, into the method for ablating and applying thermal energy to patient tissue as is taught by Demarais, to produce the predictable result of ablating and neutralizing tissue, as is taught by Kadamus, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Claim 20-21, 23, and 26-29 are rejected under 35 U.S.C. 103 as being unpatentable over Demarais (US 20070135875 A1) in view of Palero (US 20180133469 A1).
Regarding claim 20, Demarais teaches the method of claim 13.
Demarais fails to teach the method wherein a temperature of the target tissue area is raised to greater than 1000C for less than 1 second.
Demarais does however teaches the neuromodulation as occurring through a variety of mechanism including ablation wherein the temperature may be above 45 0C for ablative thermal injury ([0029], [0074], [0102]). This temperature threshold to conduct neuromodulation is further discussed as being a function of duration ([0032], [0035]).
Palero discusses ablation as occurring when the tissue is heated sufficiently to cause vaporization which occurs at temperatures higher than 100 0C ([0009]).
Palero further discusses the length of time required to produce a tissue ablation temperature, which is above 100 0C, this length of time being less than 1 second ([0117]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the known relationship between time and tissue temperature required to cause ablation, as is taught by Palero, into the method for ablating tissue, as is taught by Demarais, to produce the predictable result of thermally ablating tissue based on a known temperature and duration relationship, as is taught by Palero, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Regarding claim 21, in accordance with the above rejection of claim 13, Palero further teaches the method of claim 13, wherein a temperature of the target issue area is raised to greater than 110°C for less than 1 second ([0009], [0117]).
Regarding claim 23, in accordance with the above rejection of claim 13, Palero further teaches the method of claim 13, wherein electrical energy is applied for a duration of less than 1 second ([0117]).
Regarding claim 26, Demarais teaches the method of claim 13, wherein the thermal energy is applied to raise a temperature of the target tissue area to greater than 40°C and less than 1000C for more than 1 second ([0029]- [0031], [0092]).
In accordance with the above rejection of claim 13, Palero teaches the electric field being applied to raise a temperature of the target tissue area to greater than 1000C for less than 1 second ([0117]).
Regarding claim 27, Demarais teaches the method of claim 13, wherein the thermal energy is applied to lower a temperature of the target tissue area to less than 25°C for more than 1 second ([0029]- [0031], [0092]).
In accordance with the above rejection of claim 13, Palero teaches the electric field being applied to raise a temperature of the target tissue area to greater than 1000C for less than 1 second ([0117]).
Regarding claim 28, Demarais teaches the method of claim 13, wherein the thermal energy is applied to raise a temperature of the target tissue area to greater than 40°C and less than 1000C for more than 1 second ([0029]- [0031], [0092]).
In accordance with the above rejection of claim 13, Palero teaches the electric field being applied for electroporation for less than 1 second to cause an irreversible tissue change ([0117]).
Regarding claim 29, Demarais teaches the method of claim 13, wherein the thermal energy is applied to lower a temperature of the target tissue area to less than 25°C for more than 1 second ([0029]- [0031], [0092]).
In accordance with the above rejection of claim 13, Palero teaches the electric field being applied for electroporation for less than 1 second to cause an irreversible tissue change ([0117]).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Demarais (US 20070135875 A1) in view of Sharma (US 20190388133 A1).
Regarding claim 24, Demarais teaches the method of claim 13.
However, Demarais fails to teach the method wherein a pressure at the target tissue area is not increased above 5 atm.
Sharma teaches a device and method for ablating tissue by the delivery of an ablative agent (Abstract).
Sharma further teaching delivering the ablative agent to a pressure equal or less than 5 atm (Col. 5, Lines 40-55)
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the known pressure limit when delivering an ablative agent to patient tissue, as is taught by Sharma, into the method for ablating patient tissue by the delivery of a thermal fluid as is taught by Demarais, to produce the predictable result of ablating patient tissue within known limits, as is taught by Sharma, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Conclusion
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/L.R.L./Examiner, Art Unit 3794