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 § 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.
Claims 1-4 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Independent claim 1 is drawn to an “electroporation device” that comprises “an electronic unit provided with a signal generator and a power amplifier”. The electroporation device is also “adapted to supply to at least a pair of electrodes…a periodic voltage”. The electrodes are said to have an elongated rectangular shape and be spaced apart from each other. It is unclear, however if the “electrodes” are required features of the claimed electroporation device. They are required for practical use of the invention and are referenced throughout the body of the claim. However, the electrodes are not positively recited, and this creates a lack of clarity regarding the metes and bounds of the claimed invention. It is recommended that the claim are amended so that subject matter of lines 4-5 (“the electrodes with elongated rectilinear shape…”) is included in the following line 6 to make it clear that the electroporation device comprises i) at least a pair of electrodes and ii) an electronic unit.
An exemplary amendment is as follows:
An electroporation device adapted to supply to out having voltage V and controllable total duration τ;
the electroporation device (1) comprises
at least a pair of electrodes (2-a, 2-b) with elongated rectilinear shape have a section S and are arranged facing and spaced from each other by a distance d, and
an electronic unit provided with a signal generator (3) and a power amplifier (4) which supplies the voltage Vout to the electrodes (2-a, 2-b);
the electroporation device (1) is configured…
With respect to independent claim 1, it is additionally noted that the symbol ρ is not defined by the claim. For purposes of clarity, it is recommended that the claim indicate that ρ is the density of the tissue.
With respect to claim 2, it is unclear why the voltage V introduced in claim 1 is referred to as “the voltage torque V”. It is unclear if this is intended to refer to a different value or parameter. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Ronchetti (US 20140148876) in view of Waldstreicher (US 20210236815).
With respect to claim 1, Ronchetti discloses an electroporation device adapted to supply to at least a pair of electrodes (Figure 1:5a, 5b) in a portion of tissue of the human body having a voltage Vout and a controllable total duration τ. Paragraph [0010] states that the electrodes 5a,b are “needle-shaped”, and therefore have an elongated rectilinear shape. An electronic unit (Figure 1:10) having a signal generator (Figure 1:3) and a power amplifier (Figure 1:4) is provided in order to supply voltage Vout to the electrodes. The electroporation device is configured to generate and supply a pulse to the pair of electrodes, and then to measure the current which flows between the pair of electrodes. A resistance (i.e., impedance) value may be calculated using Ohm’s Law. See paragraph [0019] (“The device 1 is provided with a plurality of sensors that monitor continuously the electrical quantities of the electroporation process in progress; in particular, sensors 12, 13, 14 are provided, designed to measure the instantaneous value of the current le supplied to each pair of electrodes 5a, 5b, the voltage value Ve applied to said pair of electrodes, and the impedance Z(ω) present between said pair of electrodes”). Paragraphs [0032]-[0036] indicate that it is then possible to calculate, select and store a pair of values of total duration and voltage that satisfy the inequality:
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More specifically, paragraph [0032] states that the energy dose for reversible electroporation is calculated as:
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where τ is the conductivity of the tissue (and therefore equal to the inverse of resistivity σ). Ronchetti indicates that t is the time duration of each pulse. E is known to be equal to (V/d). Ronchetti additionally considers the number of pulses supplied k.
Ronchetti, however, does not appear to expressly teach that a resistance value RA,B is detected between the pair of electrodes by applying a test pulse at a known voltage Vtest and measuring the current Itest.
Waldstreicher discloses a system for applying a periodic voltage to the tissue of a human body using at least one pair of electrodes. Waldstreicher teaches in paragraphs [0326] and [0327] that variances in the resistance RA,B of a tissue are accounted for by initiating a series of test pulses at a known voltage Vtest and measuring the produced current Itest (“the monitoring and test pulse conditions may be used to determine the properties of the tissue in the electrical system and provide adjustments to the energy delivery algorithm… any change in output current due to impedance differences in the patient tissue system, will also result in compensatory changes in the delivered voltage”)
Before the effective filing date of the claimed invention, it would have been obvious to ensure that at least a first test pulse Vtest is performed when using the apparatus of Ronchetti. Waldstreicher teaches that it is important to determine the properties of the treated tissue and to provide necessary adjustments, including modifying voltage in response to detected impedance differences. Furthermore, Waldstreicher and Ronchetti each describe how voltage and treatment duration are modifiable variables that are optimized through routine experimentation. See for example paragraph [0044] of Ronchetti, which indicates that treatment time and the number of pulses per unit time may be adjusted in response to a reduction in voltage, as well as paragraph [0028] (“Block 130 computes (in a known way by applying Ohm's law once the impedance Z is known) the value of the voltage that can be applied to the electrodes necessary to obtain an increase of the current and bring the electroporation current to a target value”).
With respect to claim 2, Ronchetti and Waldstreicher disclose the combination as described above. Solving an equation by fixing at random one of two parameters and then solving for the other according to an iterative process is considered to be well known in the art.
With respect to claims 3 and 4, Ronchetti and Waldstreicher disclose the combination as described above. It is well known in the art that V=IR (again, Ohm’s Law), and so those of ordinary skill would understand how to solve for the maximum voltage deliverable given an established resistance value and a maximum current.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The Kashanin (US 20220162540), Rubinsky (US 20080132885), and Firouzi (US 20200048599) references teach the state of the art regarding electroporation devices.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN ANDREW BOWERS whose telephone number is (571)272-8613. The examiner can normally be reached M-F 7am-5pm.
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, Michael Marcheschi can be reached at (571) 272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NATHAN A BOWERS/Primary Examiner, Art Unit 1799
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