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 .
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, 10-12, and 17-31 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by US 2020/0147371 Pakhomov et al., hereinafter “Pakhomov”.
Regarding claim 1, Pakhomov discloses a method of applying energy to a target tissue or cell (Abstract), the method comprising: positioning a targeting electrode on or adjacent to the target tissue or cell (Para 12, 14, 40, and 64; Figure 14A, electrode in region C-C’); applying a first train of sub-microsecond unipolar pulses from a first electrode (Para 14-15 and 103; Figure 14A, from electrodes a-a’) and a second train of sub-microsecond unipolar pulses from a second electrode (Para 14-15 and 103; Figure 14A, from electrodes b-b’), wherein the first and second trains of sub-microsecond unipolar pulses (Para 103, see also Para 40 and Figure 14a) are concurrently applied (Para 14-15) and are out of phase so that the first and second trains of sub-microsecond unipolar pulses sum at the target tissue or cell (Para 101 and 105 and see also Figure 14a; to be out of phase means two waves of the same frequency are exactly inverted relative to each other; that is exactly what Figure 14a shows a-a’ and b-b’ are inverted signals that sum at the target tissue c-c’, see also Para 103).
Regarding claim 2, Pakhomov discloses the first and second trains of sub- microsecond unipolar pulses are 180 degrees out of phase (Para 101 and 105 and see also Figure 14a; to be 180 degrees out of phase means two waves of the same frequency are exactly inverted relative to each other; that is exactly what Figure 14a shows a-a’ and b-b’ are inverted signals that sum at the target tissue c-c’).
Regarding claim 3, Pakhomov discloses the first and second trains are concurrently applied (Para 14-15) so that both the targeting electrode and the first electrode operate as a ground electrode when the second electrode is delivering a unipolar pulse of the second train of sub-microsecond unipolar pulses, and both the targeting electrode and the second electrode operate as a ground electrode when the first electrode is delivering a unipolar pulse of the first train of sub-microsecond unipolar pulses (Para 40).
Regarding claim 4, Pakhomov discloses adjusting an amplitude or an electric field strength of the sub-microsecond unipolar pulses of the first train of sub-microsecond unipolar pulses and of the second train of sub-microsecond unipolar pulses to modify an amplitude or an electric field strength of a summed unipolar pulse at the target tissue or cell (Para 23 and 40).
Regarding claim 5, Pakhomov discloses the first and the second trains of sub-microsecond unipolar pulses have a pulse duration of less than 999 ns (Para 12; this interval is disclosed).
Regarding claim 6, Pakhomov discloses applying the first train of sub-microsecond unipolar pulses from the first electrode and the second train of sub- microsecond unipolar pulses from the second electrode further comprises modifying the target tissue or cell (Para 7, 54, 80, and 104).
Regarding claim 7, Pakhomov discloses modifying comprises electroporating, exciting or ablating the target tissue or cell (Para 7, 54, 80, and 104; All are disclosed).
Regarding claim 10, Pakhomov discloses the first train of sub-microsecond unipolar pulses is applied from both the first electrode (Figure 14a, element a) and a third electrode (Figure 14a, element a’) and the second train of sub-microsecond unipolar pulses is applied from both the second electrode (Figure 14a, element b) and a fourth electrode (Figure 14a, element b’).
Regarding claim 11, Pakhomov discloses the first and the second trains of sub-microsecond unipolar pulses sum at the target tissue or cell to form a unipolar pulse having a pulse width that is equivalent to a burst duration of the first train and the second train (Para 49, 113, and 117).
Regarding claim 12, Pakhomov discloses positioning the target electrode comprises positioning such that the target tissue or cell(s) is within a comet- shaped region around the targeting electrode, a tail of which extends towards the first and the second electrodes applying the first and the second trains (Figure 14a shows the described shape from electrodes a and b towards tail c-c’), the method further comprising controlling a depth and/or a direction of an electric field at the targeting electrode (Para 100).
Regarding claim 17, Pakhomov discloses a system for applying energy to a target tissue or cell (Abstract and Figure 3), the system comprising: a first output configured to couple to a first one or more electrode(s) (Para 61 and 64; every electrode has an output, i.e. applicator; Para 14-15 and 103; Figure 14A, from electrodes a-a’); a second output configured to couple to a second one or more electrode(s) (Para 61 and 64; every electrode has an output, i.e. applicator; Para 14-15 and 103; Figure 14A, from electrodes b-b’); a third output configured to couple to a targeting electrode (Para 61 and 64; every electrode has an output, i.e. applicator; Para 12, 14, 40, and 64; Figure 14A, electrode in region C-C’); a pulse generator (Figure 3, element 305) configured to generate a first train of sub-microsecond unipolar pulses (Para 14-15 and 103; Figure 14A, from electrodes a-a’) and a second train of sub-microsecond unipolar pulses (Para 14-15 and 103; Figure 14A, from electrodes b-b’), wherein the first and the second trains of sub-microsecond unipolar pulses are 180 degrees out of phase (Para 101 and 105 and see also Figure 14a; to be 180 degrees out of phase means two waves of the same frequency are exactly inverted relative to each other; that is exactly what Figure 14a shows a-a’ and b-b’ are inverted signals that sum at the target tissue c-c’); and a controller (Figure 3, element 303) configured to apply the first train of sub-microsecond unipolar pulses to the first output concurrently with the second train of sub-microsecond unipolar pulses to the second output (Para 17), and to couple the third output to the targeting electrode (Para 17).
Regarding claim 18, Pakhomov discloses the first one or more electrode(s) coupled to the pulse generator through the first output (Figure 3 and Para 64; the applicator(s) includes electrodes that couple to pulse generators), the second one or more electrode(s) coupled to the pulse generator through the second output (Figure 3 and Para 64; the applicator(s) includes electrodes that couple to pulse generators), and the targeting electrode coupled to the pulse generator through the third output (Figure 3 and Para 64; the applicator(s) includes electrodes that couple to pulse generators).
Regarding claim 19, Pakhomov discloses the first one or more electrode(s) and the second one or more electrode(s) are part of an applicator (Para 64).
Regarding claim 20, Pakhomov discloses at least one of the first one or more electrode(s), the second one or more electrode(s) and the targeting electrode comprises a needle electrode (Para 64).
Regarding claim 21, Pakhomov discloses at least one of the first one or more electrode(s), the second one or more electrode(s) and the targeting electrode comprises a non-penetrating electrode (Para 64).
Regarding claim 22, Pakhomov discloses the controller is integrated with the pulse generator (See Figure 3, the controller and pulse generators are integrated in 301; see also Para 12).
Regarding claim 23, Pakhomov discloses the controller is configured to adjust an amplitude or an electric field strength of the first train of sub-microsecond unipolar pulses and the second train of the sub-microsecond unipolar pulses (Para 23 and 40).
Regarding claim 24, Pakhomov discloses the controller is configured to adjust an electric field strength of the first train of sub-microsecond unipolar pulses and the second train of sub-microsecond unipolar pulses (Para 17) such that an electric field strength of a summed unipolar pulse at the targeting electrode is between 0.01 kV/cm and 10 kV/cm (Para 17).
Regarding claim 25, Pakhomov discloses the controller is configured to adjust a burst duration of the first train of sub-microsecond unipolar pulses and the second train or sub-microsecond unipolar pulses (Para 49, 113, and 117).
Regarding claim 26, Pakhomov discloses the controller is configured to adjust the burst duration of the first train of sub-microsecond unipolar pulses and the second train of sub- microsecond unipolar pulses so that a pulse width of a summed unipolar pulse at the targeting electrode is between 1 microsecond and 100 milliseconds (Para 49, 113, and 117).
Regarding claim 27, Pakhomov discloses the first one or more electrode(s), the second one or more electrode(s) and the targeting electrode are arranged to define a triangle or a pyramid (Figure 14a shows the described shape, i.e. a triangle or pyramid, from electrodes a and b towards tail c-c’).
Regarding claim 28, Pakhomov discloses the first one or more electrodes comprises a first electrode(Figure 14a, element a) and a fourth electrode (Figure 14a, element a’), the second one or more electrodes comprises the second electrode (Figure 14a, element b) and the fifth electrode (Figure 14a, element b’), the system further comprising a fourth output coupled to the fourth electrode and a fifth output coupled to the fifth electrode (Para 61 and 64; every electrode has an output, i.e. applicator; Para 14-15 and 103), wherein the controller is configured to apply the first train of sub-microsecond unipolar pulses to both the first output and the fourth output and to apply the second train of sub-microsecond unipolar pulses to both the second output and the fifth output (Para 17 and 40).
Regarding claim 29, Pakhomov discloses the first electrode, the second electrode, the fourth electrode and the fifth electrode are part of an applicator (Para 64).
Regarding claim 30, Pakhomov discloses the first electrode, the second electrode, the fourth electrode, and the fifth electrode are arranged in a plane (Figures 7 and 15A and Para 64).
Regarding claim 31, Pakhomov discloses the targeting electrode, the first electrode, the second electrode, the fourth electrode and the fifth electrode define a pyramid with the targeting electrode at an apex of the pyramid (Figure 14a shows the described shape, i.e. a pyramid, electrodes a, a’, b, and b’ are surface electrodes, electrode c-c’ is a tissue penetrating electrode that sits deeper in the tissue therefore forming a pyramid with the other 4 electrodes).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Examiner also indicates that references US 8,926,606 Davalos and US 2019/0133671 Davalos are also relevant references that are made of record to expedite prosecution. Examiner believes those two references can also be relied on for a rejection against these claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AYA ZIAD BAKKAR whose telephone number is (313)446-6659. The examiner can normally be reached on 7:30 am - 5:00 pm M-Th.
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/AYA ZIAD BAKKAR/
Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
Prosecution Insights