DETAILED ACTION
Claim 33 is new. Claims 4, 8, 13-21, and 25 are canceled. A complete action on the merits of pending claims 1-3, 5-7, 9-12, 22-24 and 26-33 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 § 112
Claims 1-7, 9-12, 22-24 and 26-33 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. Claims 1 and 32 state “…the structural member is configured to be insulated from the tissue and the bonding and insulating material is provided between…”. It appears there needs to be some punctuation. It is unclear if the structural member is insulated from the tissue and bonding with the insulating material provided between or is the structural material insulated from the tissue with the bonding and insulating material provided between. The other claims are rejected on dependency.
Claim Rejections - 35 USC § 103
Claims 1-3, 5-7, 10-12, 26, and 30-33 are rejected under 35 U.S.C. 103 as being obvious over Deem et al US 20050288730 in view of Nguyen et al US 20200390455, Danaek US 20030233099, and Olson US 20190021620.
Regarding claim 1, Deem teaches a probe (Fig. 8 apparatus 250), comprising: an insertion tube (Fig. 8 sheath 150) configured for insertion into a body cavity of a patient; and a basket assembly connected distally to the insertion tube (Fig. 8 basket 254) and comprising a plurality of spines (Fig. 8 wires 253), which are configured to contact tissue within the body (Fig. 8 RA); and an electrical signal generator (Fig. 4 generator 100) configured to apply between one or more pairs of the spines bipolar pulses (par. [0099]) having an amplitude sufficient to cause irreversible electroporation (IRE) in the tissue contacted by the spines (pars. [0083] and [0087]).
Deem does not explicitly teach each of the plurality of spines comprising a structural member and a flexible printed circuit board bonded to the structural member, the flexible printed circuit board comprising an electrode along the entire length of the spine such that each spine is configured to permit current flow through tissue between one or more other spines of the plurality of spines along the entire length of the spine from a proximal end of the basket assembly to a distal end of the basket assembly the structural member is configured to be insulated from the tissue and the bonding and insulating material is provided between a second side of the flexible printed circuit board and the structural member, the second side of the flexible printed circuit board being opposite the first side, such that the flexible printed circuit board is spaced from the structural member by the bonding and insulating material. However, Deem teaches many configurations for the conductive areas (Figs. 5, 6, and 21) and struts with a conductive material forming electrodes 256 on an insulative substrate (par. [0098]).
Nguyen, in an analogous device, teaches that the struts can be conductive on all the strut area or on portions of the strut (par. [0699]). The conductive material on element 140 can be coated on (par. [0678]).
It would have been obvious to one of ordinary skill in the art before the time the invention was effectively filed to substitute the conductive configuration of Deem with the configuration of Nguyen. Having more of the conductor exposed is seen to perform equally as well and would yield the predictable result of tissue destruction. Further, Deem contemplates having a single continuous electrode over the strut rather than multiple or segmented electrodes (par. [0099]).
Nguyen does not explicitly teach each spine comprising a structural member and a flexible printed circuit board bonded to the structural member.
Danaek, in an analogous device, teaches where the spines are a printed flexible circuit on a leg, which is the structural member. Other examples of acceptable heat transferring elements are heaters, conductive paint, and RF electrodes that can be soldered, welded, adhered, or otherwise bonded to the support structures (par. [0023]).
Olson, in an analogous device, teaches a wire 40 that is inside of insulating tube 38 (Fig. 4). Conductive material is then put on body 38 of spline 36 (Figs. 5-9)
It would have been obvious to one of ordinary skill in the art before the time the invention was effectively filed to substitute the electrodes placed on an insulator as taught by Deem with the printed flexible circuit as in Danaek and Olson. Any of the methods presented in Danaek to create an electrode on and bonding it to a support member are seen to preform equally well. This would yield the predictable result of a predictable result of a plurality of spines made of a support member with a conductive flexible circuit for treating tissue.
Regarding claim 2, Deem teaches wherein the spines have respective proximal and distal tips, wherein the proximal tips of the spines are joined mechanically at a proximal end of the basket assembly (Fig. 8 connection 255a), and the distal tips of the spines are joined mechanically at a distal end of the basket assembly (Fig. 8 255b), and the spines bow radially outward when the basket assembly is deployed in the body cavity, thereby contacting the tissue in the body cavity (Fig. 8).
Regarding claim 3, Deem teaches wherein the basket assembly has a stable collapsed state, and wherein the apparatus comprises a puller attached to the distal end of the basket assembly (par. [0097] inner shaft of 252) and slidably disposed within the insertion tube, so that the spines bow radially outward in response to pulling the puller in a proximal direction through the insertion tube (par. [0097] approximating the distal connection 255b to 255a by moving the inner shaft of catheter 252 relative to the outer shaft of catheter 252).
Regarding claim 5, Deem teaches wherein the insertion tube comprises a catheter configured for insertion into a chamber of a heart of the patient, and the spines are configured to contact and apply the electrical signals to myocardial tissue within the chamber (This is intended use for the device, as stated in par. [0039] this device is used in structures like the renal vein or artery. This device is capable of being used in the heart and treat myocardial tissue since it is able to fit in blood vessels and provide electroporation).
Regarding claim 6, Deem teaches wherein the spines comprise drawn metal ribbons (par. [0096]).
Regarding claim 7, Deem teaches wherein the metal ribbons comprise a nickel-titanium alloy (par. [0096]).
Regarding claim 10, Deem teaches wherein the sequence of the bipolar pulses comprises pairs of pulses, wherein each pair comprises a positive pulse and a negative pulse (See rejection of claim 1 regarding bipolar and IRE as the claim sits this is IRE using bipolar pulsing. The claim does not require, for example, one electrode to have a train of positive pulses and the other negative, or that one electrode sends out a positive pulse than the other electrode sending out a negative pulse after a delay).
Regarding claim 11, Deem teaches wherein the electrical signal generator is configured to apply the bipolar pulses between first and second sets of the spines, wherein at least one of the sets comprises two or more of the spines (par. [0099]).
Regarding claims 12 and 32, Deem teaches comprising a controller configured to transmit control signals to the electrical signal generator (par. [0049] circuitry allowing for the monitoring of signals), wherein the electrical signal generator comprises: a pulse generation assembly, configured to receive the control signals from the controller and to transmit sequences of bipolar pulses with an amplitude and duration responsive to the control signals (par. [0083] generator sending signals based on parameters); and a pulse routing assembly, comprising a configurable network of switches, which are configured to receive the control signals from the controller, to receive the sequences of bipolar pulses from the pulse generation assembly, and to select sets of the spines responsively to the received control signals, each set comprising one or more of the spines, so as to the transmit the sequences of bipolar pulses through the selected sets (par. [0046] circuitry allowing for dynamic focusing of electrodes par. [0099] the electrodes are switched on as pairs or subsets). Even though the figures or paragraphs don’t give depictions to the units the functions are being performed by different circuitries in the system.
Regarding claim 26, Deem teaches the plurality of spines being insulated from each other at the proximal end and at the distal end of the basket assembly (Fig. 8 255a and 255b separating the splines from one another).
Regarding claim 30, Deem, Nguyen, Danaek, and Olson teach the basket assembly further comprises a position sensor disposed within the basket assembly (Deem par. [0049] and Danaek par. [0020]).
Regarding claim 31, Deem, Nguyen, Danaek, and Olson teach the electrode of each spine being exposed along the entire length of the spine such that the electrical signal generator is configured to apply the bipolar pulses to cause the IRE in the tissue contacted by the spines, with the electrodes being configured to cause the IRE in the tissue with a width between 6-12 millimeters (Deem Figs. 1 and 9 the IRE is done in the pulmonary vein and 6-12mm is the width of the pulmonary vein).
Regarding claim 33, Olson further teach wherein the bonding and insulating material covers at least a portion of the first side of the flexible printed circuit board (Fig. 15).
It would have been obvious to one of ordinary skill in the art before the time the invention was effectively filed to substitute the insulator configuration of this embodiment of Olson with the device of Deem, Nguyen, Danaek, and Olson. It is seen to preform equally as well as demonstrated by having the electrode parameter covered or uncovered in Olson Figs. 14-22. It would yield the predictable result allowing the electrode to sit on an insulator and provide electrosurgical energy.
Claims 9, 22-24, and 27-29 are rejected under 35 U.S.C. 103 as being unpatentable over Deem, Nguyen, Danaek, and Olson as applied to claim 1 above, and further in view of Byrd et al US 20210161582.
Regarding claims 9 and 27-29, Deem, Nguyen, Danaek, and Olson do not explicitly teach wherein the bipolar pulses applied by the electrical signal generator comprise a sequence of bipolar pulses having an amplitude of at least 200 V, and a duration of each of the bipolar pulses is less than 20 milliseconds and wherein the bipolar pulses applied by the electrical signal generator comprise a sequence of bipolar pulses having an amplitude of at least 200 V, a pulse width duration of 5 µs or less, and a spacing duration of 5 µs or less and wherein the bipolar pulses applied by the electrical signal generator comprise a plurality of sequences of bipolar pulses forming a pulse train, the electrical signal generator being further configured to output a plurality of pulse trains forming a burst and wherein each burst comprises a duration of 500 milliseconds or less. However, Deem teaches a duration up to 20 milliseconds with 50V (par. [0136]).
Byrd, in an analogous device, teaches where the basket assembly can operate at 500 V to 3.5 kV for a duration of 0.5 to 5 milliseconds (par. [0065]). The pulses 700 are able to be sent in a pulse train of two or more pulses and the time between the pulses is 0.5 to 50 milliseconds (par. [0069]). The interval between the positive and negative pulse is about 2 µs (par. [0061]).
It would have been obvious to one of ordinary skill in the art before the time the invention was effectively filed to modify voltage and duration of the pulses in Deem, Nguyen, Danaek, and Olson to have an amplitude of at least 200 V and a duration less than 20 milliseconds, as taught by Byrd. The type of pulse generated is based on the type of tissue that is being operated on (Byrd par. [0029]). Further, amplitude and duration are inversely related so when one is decreased the other must increase to achieve an effective electroporation (Byrd par. [0051]). It would be apparent to a person of ordinary skill in the art what tissue they are operating on and the appropriate parameters to achieve effective irreversible electroporation.
Regarding claims 22-24, Deem, Nguyen, Danaek, and Olson do not explicitly teach the selected sets being selected based on an identified region of the tissue to be electroporated and the pulse routing assembly being further configured to transmit the sequences of bipolar pulses through the selected sets in a predefined order of selected sets and the pulse routing assembly being further configured to transmit the sequences of bipolar pulses through the selected sets in alternation between the selected sets.
Byrd, in an analogous device, teaches where the area for electroporation is determined by a program. The program selects pairs of electrodes to use to provide electroporation (par. [0029]). Different pairs of electrodes can be switched on and off during the procedure (par. [0052]).
It would have been obvious to one of ordinary skill in the art before the time the invention was effectively filed to modify the electrode pattern of Deem, Nguyen, Danaek, and Olson to have alternating electrodes with the ability to change electrode pairs, as in Byrd. The ability change electrode pairs allow for different strategies to be used for different electroporation procedures (par. [0052]).
Response to Arguments
Applicant’s arguments with respect to claims 1 and 32 have been considered but are moot because the new ground of rejection does not rely on the same combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
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/R.T.C./Examiner, Art Unit 3794
/LINDA C DVORAK/Primary Examiner, Art Unit 3794