DETAILED ACTION
Claims 1-12 are canceled. A complete action on the merits of pending claims 13-28 appears below.
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 .
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 Rejections - 35 USC § 103
Claims 13-19 and 21-28 are rejected under 35 U.S.C. 103 as being unpatentable over Mickelsen US 20170065339 in view of Dimmer US 20020193833.
Regarding claims 13, 25 and 28, Mickelsen teaches the system comprising: a treatment device including: an elongate body (Fig. 1 catheter 15) having a proximal portion and a distal portion defining a distal tip; a first electrode, the first electrode defining the distal tip; and a second electrode (Fig. 1 portion with electrodes 17); and an energy generator in communication with the treatment device (par. [0037]), the energy generator being programmed to: deliver biphasic charge-neutral pulses through the second electrode; deliver non-charge-neutral pulses between the biphasic charge-neutral pulses from the second electrode, the second electrode being configured to be an anodic electrode during the delivery of non-charge-neutral pulses (pars. [0077] and [0078] monophasic or biphasic and if the charges are biphasic they can be balanced or unbalanced and Fig. 13 where the middle negative pulse is the non-charge-neutral and the positive and negative are the biphasic pulses); and deliver pulsed energy through the first electrode one of concurrently with and independently from delivery of the non-charge-neutral pulses and the biphasic charge-neutral pulses (par. [0096] application of microwaves to lower the IRE threshold).
Mickelsen does not explicitly teach wherein each of the non-charge-neutral pulses imparts a charge and is one selected from the group consisting of a biphasic pulse including a direct current (DC) offset and an asymmetric biphasic pulse and wherein a waveform including the biphasic charge-neutral pulses and the non-charge neutral pulses between the biphasic charge-neutral pulses delivers a direct current (DC) offset to an area of tissue corresponding to each pulse of the non-charge neutral pulses.
Dimmer, in an analogous method, teaches using a DC offset in combination with bipolar pulses (claim 17). The DC offset can be applied before, during or after the biphasic pulse (par. [0066] and Fig. 7D). Fig. 7D shows the DC offset before, during, and after each biphasic pulse but as state in par. [0066] it can be just after. Thus, after each net zero pulse there can be a DC offset.
It would have been obvious to one of ordinary skill in the art before the time the invention was effectively filed to modify the method of Mickelsen to have a DC offset before or after a biphasic pulse, as in Dimmer. Adding a DC offset before or after a biphasic pulse allows for better movement of therapeutic agents (par. [0066]). Since Dimmer teaches a DC offset after each charge neutral pulse when combine with Mickelson there is a DC offset between two charge neutral pulses. Based on Dimmer, a DC offset can be placed anywhere depending on when the practitioner would like migration of a therapeutic agent.
Regarding claim 14, Mickelsen teaches the method comprising: positioning a first treatment device at a first location relative to the area of target tissue; positioning a second treatment device at a second location relative to the area of target (Fig. 1); delivering biphasic charge-neutral pulses between the first and second treatment devices at a first amplitude; and delivering non-charge-neutral pulses between the first and second treatment devices at a second amplitude (Fig. 14 and par. [0077]).
Regarding claim 15, Mickelsen teaches wherein the first amplitude is greater than the second amplitude (Fig. 14 and par. [0077]).
Regarding claim 16, Mickelsen teaches wherein the first amplitude is greater than the second amplitude and the non-charge-neutral pulses are one of monophasic and biphasic (par. [0077]).
Regarding claim 17, Mickelsen teaches wherein the first location is within a first chamber of a heart in contact with endocardial tissue (par. [0090]) and the second location is within a second chamber of the heart proximate the first location (Fig. 1).
Regarding claim 18, Mickelsen teaches wherein the first location is within a chamber of a heart in contact with endocardial tissue (par. [0090]) and the second location is within a pericardial space around the heart (par. [0049]).
Regarding claim 19, Mickelsen teaches wherein the first location is within a chamber of a heart in contact with endocardial tissue (par. [0090]) and the second location is within one of a coronary arterial blood vessel and a venous blood vessel ([0069]).
Regarding claim 21, Mickelsen teaches positioning a treatment device having a plurality of electrodes in contact with an area of target tissue (Fig. 1); delivering biphasic energy pulses between at least two of the plurality of electrodes to at least one of stun and ablate cells within the area of target tissue; and after delivering the biphasic energy pulses, delivering at least one of monophasic energy pulses and continuous direct current to the cells within the area of target tissue to ablate the cells within the area of target tissue.
Regarding claim 22, Mickelsen teaches wherein the second electrode is configured to at least partially puncture an area of tissue (par. [0049] the electrodes can use a puncturing apparatus in the heart), the second electrode extending distally from the first electrode (Fig. 1 the electrodes are in a line one being distal or proximal compared to another).
Regarding claim 23, Mickelsen teaches wherein the energy generator is further programmed to: establish a predetermined charge threshold (par. [0038]); calculate a total amount of charge delivered to the target tissue, the total amount of charge being based on a number and duration of the delivered non-charge-neutral pulses (par. [0054]); and automatically adjust delivery of the non-charge-neutral pulses to maintain the predetermined charge level (par. [0052]).
Regarding claim 24, Mickelsen teaches wherein each of the non-charge-neutral pulses is a monophasic pulse (Fig. 13 either of the middle 103 or 104).
Regarding claims 26 and 27, Mickelsen teaches wherein delivering the biphasic charge-neutral pulses stuns and ablates cells within an area of target tissue, and wherein delivering non-charge-neutral pulses between the biphasic charge-neutral pulses electrolyzes and ablates the cells within the area of target tissue and wherein delivering non-charge-neutral pulses between the biphasic charge-neutral pulses electrolyzes cells within an area of target tissue to reduce an amount of voltage to ablate the area of target tissue (pars. [0003] [0005] this is just what electroporation is and what happens when a current is passed through a cell).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Mickelsen and Dimmer as applied to claim 14, and further in view of Chornenky US 20030060856.
Regarding claim 20, Mickelsen and Dimmer do not explicitly teach further comprising: before delivering biphasic charge-neutral pulses between the first and second treatment devices at the first amplitude, delivering energy between the first and second treatment devices, the energy being sufficient to heat cardiac tissue to a temperature of between 45 °C and 60 °C.
Chornenky, in an analogous medical device, teaches using RF energy to heat the tissue region to 45-50 °C prior to applying electroporation treatment (par. [0029]).
It would have been obvious to one of ordinary skill in the art before the time the invention was effectively filed to modify the method of Mickelsen to heat the tissue to 45-50 °C with RF energy, as in Chornenky. The heating before electroporation increases the susceptibility of neoplastic cells (Chornenky Abstract).
Response to Arguments
Applicant's arguments filed 1/28/26 have been fully considered but they are not persuasive. The applicant argues that Mickelsen cannot both (i) teach delivering non-charge-neutral pulses between biphasic charge-neutral pulses and (ii) not teach delivering non-charge-neutral pulses between the biphasic charge-neutral pulses to impart the charge to the area of target tissue. The examiner does believe that this is the case since Mickelsen uses biphasic pulses to make the area end charge neutral. As stated in the Response to Arguments in the actions filed 3/27/24, 9/30/24, and 4/30/25; as well as the Interviews whose summaries are filed 3/12/24 and 6/14/24, a biphasic pulse is made up of two monophasic pulses. Each monophasic pulse has a charge to it and the charge is there until the other pole of the biphasic pulse negates it. The reason Dimmer was brough into the rejection in claim 13 was to show the applicant that even if this was claimed in such a way that Mickelsen could not hold that interpretation, there is art that exists that has a DC offset put between biphasic pulses to read on the limitations, as presented in claim 28. The examiner did this in hopes to move prosecution forward.
The applicant argues that Dimmer teaches a DC offset before, during, and after the electroporation signal so each and every electroporation signal is combined with a DC offset. According to the cited portion this is possible but in the same paragraph [0066] it states that it can be before or after an electroporation signal. Further, more than one signal can be applied so the DC offset making the net charge would occur between biphasic charge neutral pulses.
The applicant argues that the combination of Mickelsen and Dimmer would have the phasic pulses impart a charge. This is not the case it is a DC offset that provides the charge as stated in Dimmer par. [0066] not the biphasic pulse.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RYAN T. CLARK whose telephone number is (408)918-7606. The examiner can normally be reached on Monday-Friday 7AM-3PM MT.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached on (571)272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/R.T.C./Examiner, Art Unit 3794
/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794
Prosecution Insights