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 .
Response to Amendment
The amendment filed 03/29/2026 has been entered. Claims 1-3, 5, 7-14, 16-26 and 28-29 remain pending in the application. Claim 27 has been cancelled. Applicants’ acknowledgment of claim 11’s U.S.C. § 112(f) interpretation is noted. Applicant’s amendments to the claims have overcome the U.S.C. § 112(f) rejection regarding claim 8, and U.S.C. § 112(b) rejection regarding claim 8 and 11 previously set forth in the Non-final Office Action mailed 12/29/2025.
Response to Arguments
Applicant's arguments filed 03/29/2026 have been fully considered but they are not persuasive. Examiner responds to applicant’s arguments with reference to Novickij, V., Grainys, A., Lastauskienė, E. et al. Pulsed Electromagnetic Field Assisted in vitro Electroporation: A Pilot Study. Sci Rep 6, 33537 (2016). https://doi.org/10.1038/srep33537 herein referred to as “Novickij” further with reference to Novickij, V., Zinkevičienė, A., Perminaitė, E. et al. Non-invasive nanosecond electroporation for biocontrol of surface infections: an in vivo study. Sci Rep 8, 14516 (2018). https://doi.org/10.1038/s41598-018-32783-7 herein referred to as “Novickji and Zinkeviciene”.
Regarding applicant’s arguments, see page 8 lines 1-8, with respect to the rejection(s) of claim(s) 21 under U.S.C. § 102. Applicant argues Kalghatgi does not disclose PEF. Examiner respectfully disagrees. Although Kalghatgi does not explicitly disclose “PEF”, PEF is seen as application of a non-thermal high voltage electric field pulse to creates micropores (As evidenced by Novickji). Kalghatgi discloses a plasmaporation device and methods to increase uptake of substances ([Kalghatgi, (63)]) further Kalghatgi discloses plasmaporation as ‘Plasmaporation uses non-thermal (cold) plasma […] A pulsed electric field used to generate the plasma opens up temporary pores in the skin and within cell membranes to promote transdermal delivery and cellular uptake of molecules (including macromolecules), drugs, vaccines and the like.’ ([Kalghatgi, (61); bolded and italicized for emphasis], which is seen as “PEF”. Therefore, claim 21, and all dependent claims, are still rejected under U.S.C. § 102.
Regarding applicant’s arguments, see page 8 lines 18-31 and page 9 lines 1-6, with respect to the rejection(s) of claim(s) 1 under U.S.C. § 103. Applicant argues Chang does not disclose artificial intelligence (AI) algorithms. Examiner respectfully disagrees. AI is seen as computer readable software that uses algorithms to provide a prediction and/or informational output regarding a task and feature set input. While it is true AI can be specialized the term AI on it own is very comprehensive only when specifically stating which techniques used regarding search and optimization, classifiers, artificial neural networks can AI be meaningfully delineated from a predictive algorithm. At the broadest reasonable interpretation, a predictive algorithm is seen as an AI algorithm.
Further applicant argues relating a predictive algorithm to an AI algorithm would be hindsight reasoning. Examiner respectfully disagrees. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Regarding applicant’s arguments, see page 8 lines 18-31 and page 9 lines 1-6, with respect to the rejection(s) of claim(s) 1 under U.S.C. § 103. Applicant argues that Mayer does not discloses PEF to remove biofilm/microbial contaminants. Examiner respectfully disagrees. Although Chang does not explicitly disclose “PEF”, PEF is seen as application of a non-thermal high voltage electric field pulse to creates micropores (As evidenced by Novickji). Chang discloses ‘ […] Application of high-voltage pulses to the skin increases its permeability (electroporation) and enables the delivery of various substances into and through the skin […]’ which is seen as “PEF”. Further in response to applicants’ argument that “PEF” is not used to remove biofilm/microbial contaminants, Electroporation and further PEF remove microbial contamination on application (As evidenced by Novickji and Zinkeviciene), the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Regarding applicant’s arguments, see page 8 lines 18-31 and page 9 lines 1-6, with respect to the rejection(s) of claim(s) 1 under U.S.C. § 103. Applicant argues that neither Mayer nor Chang discloses “induce[s] a transmembrane potential on microbial cells” that is “proportional to the organism size therefore higher field strengths are required for bacteria which limits any damage to host tissue”. While claims are interpreted in view of the specification applicant is reminded that the specification is not read into claim limitations. Therefore, the claim 1, and all dependent claims, remain rejected under U.S.C. § 103.
Regarding applicant’s arguments, see page 12 lines 13-28, with respect to the rejection(s) of claim(s) 17 under U.S.C. § 103. Applicant argues that Pearson and Mayer do not discloses Artificial intelligence (AI) algorithm. Examiner respectfully disagrees. As mentioned above AI is seen as computer readable software that uses algorithms to provide a prediction and/or informational output regarding a task and feature set input. While it is true AI can be specialized the term AI on it own is very comprehensive only when specifically stating which techniques used regarding search and optimization, classifiers, artificial neural networks can AI be meaningfully delineated from a predictive algorithm. At the broadest reasonable interpretation, a predictive algorithm is seen as an AI algorithm.
Further applicant argues relating a predictive algorithm to an AI algorithm would be hindsight reasoning. Examiner respectfully disagrees. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Therefore, claim 17, and all dependent claims, remain rejected under U.S.C. § 103.
Regarding applicant’s arguments, see page 13 lines 21-31, with respect to the rejection(s) of claim(s) 22 under U.S.C. § 103. Applicant argues Kalghatgi does not employ PEF. Examiner respectfully disagrees. Although Kalghatgi does not explicitly disclose “PEF”, PEF is seen as application of a non-thermal high voltage electric field pulse to creates micropores (As evidenced by Novickji). Kalghatgi discloses a plasmaporation device and methods to increase uptake of substances ([Kalghatgi, (63)]) further Kalghatgi discloses plasmaporation as ‘Plasmaporation uses non-thermal (cold) plasma […] A pulsed electric field used to generate the plasma opens up temporary pores in the skin and within cell membranes to promote transdermal delivery and cellular uptake of molecules (including macromolecules), drugs, vaccines and the like.’ ([Kalghatgi, (61); bolded and italicized for emphasis]), which is seen as “PEF”. Therefore, claim 22, and all dependent claims, are still rejected under U.S.C. § 103.
Regarding applicant’s arguments, see page 13 lines 21-31, with respect to the rejection(s) of claim(s) 22 under U.S.C. § 103. Applicant argues Kalghatgi does not employ PEF. Examiner respectfully disagrees. Although Kalghatgi does not explicitly disclose “PEF”, PEF is seen as application of a non-thermal high voltage electric field pulse to creates micropores (As evidenced by Novickji). Kalghatgi discloses a plasmaporation device and methods to increase uptake of substances ([Kalghatgi, (63)]) further Kalghatgi discloses plasmaporation as ‘Plasmaporation uses non-thermal (cold) plasma […] A pulsed electric field used to generate the plasma opens up temporary pores in the skin and within cell membranes to promote transdermal delivery and cellular uptake of molecules (including macromolecules), drugs, vaccines and the like.’ ([Kalghatgi, (61); bolded and italicized for emphasis]), which is seen as “PEF”.
Regarding applicant’s arguments, see page 23 lines 1-14, with respect to the rejection(s) of claim(s) 22 under U.S.C. § 103. Applicant argues Kalghatgi teaches away from the use of electroporation. Examiner respectfully disagrees. Kalghatgi discloses a plasmaporation device and methods to increase uptake of substances ([Kalghatgi, (63)]) further Kalghatgi discloses plasmaporation as ‘Plasmaporation uses non-thermal (cold) plasma […] A pulsed electric field used to generate the plasma opens up temporary pores in the skin and within cell membranes to promote transdermal delivery and cellular uptake of molecules (including macromolecules), drugs, vaccines and the like.’ ([Kalghatgi, (61); Bolded and italicized for emphasis), which is seen as electroporation. Therefore claim 22, and al dependent claims, remain rejected under U.S.C. § 103.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 21 is/are rejected under 35 U.S.C. 102 (a)(1)/(a)(2) as being anticipated by Kalghatgi et al. (US 10765850 B2) herein referred to as “Kalghatgi”.
Regarding claim 21, Kalghatgi teaches: A method of directing a PEF signal non-invasively to tissue ([Column 10 lines 10-18]) to regenerate a wound bed and aid in a wound healing process by stimulating growth factors and promoting angiogenesis, comprising providing a pulsed electric field (PEF) signal to a vicinity of the wound. ([Column 13 lines 48-54]; “When electric pulses are applied to the skin… …when treating wounds, the energy may be increased to, for example, 500 J/cm2, without causing burns)
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 7-11, 13-14 and 26-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chang (US 20130345661 A1) herein referred to as “Chang” in view of Mayer et al. (US 20190247680 A1) herein referred to as “Mayer”.
Regarding claim 1, Chang discloses: A device for killing microbial contaminants (Abstract), comprising: a distal portion including a plurality of electrodes ([Figure 2A]; Chang discloses a device with electrodes 130 at the end) configured to provide a pulsed electric field, PEF, signal on a tissue surface in the vicinity of the microbial contaminants, ([0023];” According to the present invention…” “…The in vivo application of high-voltage pulses is well tolerated.”) wherein the PEF penetrates beneath the tissue surface; ([0023] and abstract; applying pulsed electrical current to the skin and penetrating below the stratum corneum of the skin) and a controller ([0027];” The skin abrading device 100 may further include one or more switches for controlling the device” and [0029] “electronic control circuitry”), being configured to change one or more parameters of the PEF signal ([0029];” electronic control circuitry 138 may be positioned for controlling current to the electrodes 130.”)
Chang does not disclose: Changing parameters of PEF in response to the at least one impedance sensor detecting an impedance value or a change in impedance, to control operation of the pulse generator to deliver the desired electric field for killing the microbial contaminants; at least one impedance sensor configured to assist in determination of PEF parameters to deliver a desired electric field; and a pulse generator electrically connected to the plurality of electrodes to generate the PEF signal; and wherein the plurality of electrodes comprise a return electrode and a terminal electrode, and wherein the controller is configured to switch a polarity of the return electrode and the terminal electrode.
However, Mayer discloses: at least one impedance sensor configured to assist in determination of PEF parameters to deliver a desired electric field; ([0177];” the therapeutic device comprises at least one sensory device (‘sensor’) selected from: a temperature sensor, a heart rate sensor, an EMG head, an ECG head, a pressure sensor, a voltage sensor, an imaging head, a current sensor, an impedance sensor”) Changing parameters of PEF in response to the at least one impedance sensor detecting an impedance value or a change in impedance, to control operation of the pulse generator to deliver the desired electric field for killing the microbial contaminants; ([0329]; “Optionally, the algorithm is configured for controlling one or more output devices based on the input from one or more input devices. For example, the algorithm can comprise a step of controlling an output device (e.g. energy generator such as RF generator or fluid pump or a user output device such as a UI) that is dependent or triggered by the input from a sensor (e.g. temperature sensor, ECG, or impedance sensor).”) a pulse generator electrically connected to the plurality of electrodes to generate the PEF signal ([0461];” a pulse modulator configured for control by the controller.“); and wherein the plurality of electrodes comprise a return electrode and a terminal electrode, ([0190]; “RF heads such as RF ablation heads can be configured in any manner. For example, an RF head can comprise at least two electrodes: a transmitting electrode for delivering energy and a return electrode”) and wherein the controller ([0194];” therapeutic device is connected to the controller or a console comprising the controller. “) is configured to switch a polarity of the return electrode and the terminal electrode. ([0190];” A head may optionally contain a plurality of electrodes which alternate polarity, phase, or connectivity to provide selective treatment.”) wherein the controller is configured to adjust an electric field strength of the PEF signal using a computer implemented artificial intelligence algorithm based on real-time data such as impedance, temperature, pressure and distance between electrodes ([0589]; “the imaging console sends data to the energy generator console, e.g. spatial and tissue characterization information back to the energy delivery system. In this example, the energy generator console optionally uses this data in combination with the unique parameters of the energy delivery head to control the energy generator, e.g. by adjusting treatment energies and/or selecting or modifying predictive algorithms appropriately.”)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the device as disclosed by Chang with the impedance sensor, changing in parameters using the impedance sensor, pulse modulator, terminal and return electrodes and a controller configured to switch the polarity of the electrodes and the predictive algorithm as disclosed by Mayer. The motivation being to influence output parameters ([0329]), to control RF pulses ([0461]), the transmission and the return of energy ([0190]), and to provide selective treatment ([0190]) and to detect contact of electrodes ([0589]) respectively.
Regarding claim 7, Chang in view of Mayer disclose: The device of claim 1. Mayer further discloses: wherein the controller ([0009]; “wherein said control instructions comprise instructions for controlling the console (‘control instructions’)”) is configured to deliver the PEF signal ([0282]; “The control instructions comprise one or more energy output parameters of electroporation energy”) at a threshold intensity ([0291]; “ the control instructions comprise one or more calibration parameters of a wave energy delivery head (e.g. electrode),…” ‘…for example R-L-C values, Z and Phase, complex Z and S parameters, surface area, maximum energy allowed” wherein maximum energy allowed is seen as a threshold intensity) to induce irreversible permeabilization of a cell membrane in a biofilm of the microbial contaminants thereby leading to cell death. ([0282]; “Optionally, the control instructions comprise one or more energy output parameters of electroporation energy. Optionally, the one or more energy output parameters are selected from voltage, charge, pulse rate, pulse width, joules, number of pulses, and treatment duration.”)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the device as disclosed by Chang in view of Mayer with the threshold controlled electric pulse as further disclosed by Mayer the motivation being to control wave energy delivery ([0291]).
Regarding claim 8, Chang in view of Mayer disclose: The device of claim 1. Chang further discloses: wherein the distal portion includes a port configured for removal of debris or microbes from the vicinity of the microbial contaminants when suction is applied to the port ([0007]; “The device may also have a vacuum and a vacuum entry port located on the tip at the proximal end of the handle, where the vacuum entry port has one or more apertures for evacuating fluid and debris from the surface of the skin”)
Regarding claim 9, Chang in view of Mayer disclose: The device of claim 1. Chang further discloses: the distal portion further comprising: a volume configured for providing an at least partially sealed environment when in abutment with a surface, or a volume configured for providing an at least partially sealed environment when in abutment with a surface ([0061];” 134 of the abrading structure 132 comprises one or more grooves 135. The grooves may be differently shaped, such as rounded grooves, or slotted square… …Preferably, to keep the vacuum 124 sealed, the grooves 135 are substantially even with the edge such that when the abrading structure 132 is applied to the skin, air does not escape”, wherein the volume is at least partially formed of a resilient material. ([0038];” In some embodiments, the abrading structure 132 and abrading end portion 134 comprise a unitary plastic structure, such as acrylonitrile butadiene styrene (ABS).” wherein ABS is seen as a resilient material)
Regarding claim 10, Chang in view of Mayer disclose: The device of claim 1. Chang further discloses: wherein the plurality of electrodes are protruding and/or flat relative to a device head of the device and/or comprise a smooth or irregular surface. ([Figure 2A]; Chang discloses electrodes 130 protruding from the head of the device)
Regarding claim 11, Chang in view of Mayer disclose: The device of claim 1. Chang further discloses: further comprising a dispensing means configured to dispense a fluid to the vicinity of the microbial contaminants ([0055];” FIG. 1B, fluid 120 is delivered from a fluid reservoir (not shown), which may be either part of the handle or in a separate reservoir, such as a plastic or glass tube serum, through the fluid delivery conduit 108 and out the fluid delivery tip 122 in the tip 104 of the device 100.”); and optionally wherein the fluid is a conductive fluid and/or an antiseptic fluid. ([0055];” The fluid may include one or a plurality of suitable skin enhancing agents, and/or conductive ingredients, or other suitable agents for skin cleaning and skin enhancement or facilitation of current delivery, such as water, salts, ionic or non-ionic surfactants, preservatives, alcohol, glycerol, gel, and other similar agents”)
Regarding claim 13, Chang in view of Mayer disclose: The device of claim 1. Mayer further discloses: wherein the distal portion of the device further comprises a sensor or a plurality of sensors to detect a physical environment ([0017]; “Optionally, the system further comprises one or more sensors.”) including one or combinations of temperature pressure, pH, and position of the electrodes. ([0177]; “the therapeutic device comprises at least one sensory device (‘sensor’) selected from: a temperature sensor, a heart rate sensor, an EMG head, an ECG head, a pressure sensor, a voltage sensor, an imaging head, a current sensor, an impedance sensor, a sensor of RF output (e.g. any RF output parameter), a chemical sensor, a fluid flow sensor, imaging sensor within a balloon catheter (e.g. fiber optic imager). Useful sensory signals can be provided about (e.g. in or on) an energy delivery head (e.g. temperature sensor in the tip of an ablation catheter) or provided on a separate operational head (e.g. a heart rate sensor in a location remote to an ablation catheter).”)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the device as disclosed by Chang in view of Mayer with the sensors further disclosed by Mayer the motivation being to sense an environmental effect at a target site ([0176])
Regarding claim 14, Chang in view of Mayer disclose: The device of a claim 1. Mayer further discloses: further comprising a pump ([0532];” The fluid pump is configured to deliver and/or collect fluid to/from the biological tissue at the site of the energy delivery, e.g. by providing an irrigation head (e.g. infusion port) about the operational head. Optionally, operational head (e.g. irrigation head) of the fluid pump is comingled with the energy delivery head, e.g. fixed to the energy head and provided with the RF head as a single unit” to receive a conductive medium ([0533];” The fluid is optionally any of a surgical procedure fluid, a cooling fluid, saline irrigation, a contrast agent (e.g. for fluoroscopic visualization), or local fluid (e.g. aspirated fluid from a surgical site). Optionally, the fluid pump comprises a fluid reservoir configured to provide or collect fluid to/from the operational head of the fluid pump.” at a variable rate ([0236];” The conditions of RF energy output, or monitored parameters which cause the change in operator of other connected equipment (e.g. changing the flow rate of an infusion pump connected to the generator via the USB or Ethernet interfaces)’); wherein optionally a motor/battery is connected to the pump for control ([0537];” Optionally, at least one of the first and second memory devices comprises instructions specific to the combination of the therapeutic device and the fluid pump.”) of a flow rate ([0236];” The conditions of RF energy output, or monitored parameters which cause the change in operator of other connected equipment (e.g. changing the flow rate of an infusion pump connected to the generator via the USB or Ethernet interfaces)’), wherein when the device comprises a proximal portion optionally the motor/battery is separate from the proximal portion of the device. ([0010];” Optionally, the reversible connector comprises the reversible memory operable linkage, e.g. a wired communications linkage. Alternatively, the reversible memory operable linkage comprises a wireless communications linkage (e.g. electromagnetic or optical)” wherein the memory can optionally be wireless, which is seen as separate form a proximal portion)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the device as disclosed by Chang in view of Mayer with the liquid pump further disclosed by Mayer the motivation being to deliver or collect fluid from tissue ([0532])
Regarding claim 26, Chang in view of Mayer disclose: The device of claim 1. Mayer further discloses: wherein the one or more PEF parameters include electric field current, voltage, frequency, pulse type, number of pulses, pulse interval and pulse duration. ([0465]; “A system of the invention (e.g. as detailed in Example 1) is provided, wherein the control instructions contain the specifications of energy parameters (e.g. power, voltage, waveshape, duty cycle, frequency, pulse frequency, pulse duration, impedance targets, and power adjustments to apply in response to impedance changes)”)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the device as disclosed by Chang in view of Mayer with the parameters as further disclosed by Mayer the motivation being to detect contact of electrodes ([0466])
Regarding claim 28, Chang in view of Mayer disclose: The device of claim 1. Mayer further discloses: wherein the controller is configured to change the polarity of electrodes between pulses. ([0190];” A head may optionally contain a plurality of electrodes which alternate polarity, phase, or connectivity to provide selective treatment.”)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the device as disclosed by Chang in view of Mayer with the change in polarity of electrodes as further disclosed by Mayer the motivation being to provide selective treatment ([0190])
Regarding claim 29, Chang in view of Mayer disclose: The device of claim 1. Mayer further discloses: wherein the distal portion of the device further comprises a sensor to detect temperature. ([0178]; “Optionally, a temperature sensor is provided about an energy delivery head”)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the device as disclosed by Chang in view of Mayer with the temperature sensor as further disclosed by Mayer the motivation being the to yield the predictable result of monitoring the site of energy delivery.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chang in view of Mayer further in view of Mccoy (WO 2017117273 A1) herein referred to as “Mccoy”.
Regarding claim 2, Chang in view of Mayer disclose: The device of claim 1. Chang does not disclose: wherein the plurality of electrodes are axially moveable relative to a horizontal plane and/or relative to a vertical plane.
However, Mccoy discloses: wherein the plurality of electrodes are axially moveable relative to a horizontal plane and/or relative to a vertical plane. ([0177]; “The electroporation device of clause 1, wherein the array is axially moveable with respect to the housing between a retracted position, where the electrodes are positioned inside the housing, and an extended position, where at least a portion of the electrodes are positioned outside the housing.”)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the device as disclosed by Chang in view of Mayer with the axially movable electrodes as disclosed by Mccoy the motivation being to contact the subject’s skin ([72])
Claim(s) 3 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chang in view of Mayer further in view of Zemel et al. (US 9351790 B2).
Regarding claim 3, Chang in view of Mayer disclose: The device of claim 1. Chang does not disclose: further comprising an insulating material at least partially surrounding a perimeter of at least one electrode for directing the PEF beneath the surface of the tissue. and/or comprising an insulating material surrounding a perimeter of a plurality of electrodes for directing the PEF beneath the surface of the tissue.
However, Zemel discloses: further comprising an insulating material at least partially surrounding a perimeter of at least one electrode for directing the PEF beneath the surface of the tissue. and/or comprising an insulating material surrounding a perimeter of a plurality of electrodes for directing the PEF beneath the surface of the tissue. ([Column 17 lines 17-18]; “All of the electrode geometries described herein have a separation layer (e.g., insulating layer)”)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the device as disclosed by Chang in view of Mayer with the insulation around the electrodes as disclosed by Zemel the motivation being to limit undesirable electrochemical reactions ([Column 17 lines 17-20])
Regarding claim 5, Chang in view of Mayer disclose: The device of claim 1. Zemel further discloses: wherein the plurality of electrodes are embedded in an insulating material for directing the PEF beneath the surface of the tissue; and/or wherein the electrodes comprise a coating which provides resistance to the adhesion of matter. ([Column 17 lines 17-18]; “All of the electrode geometries described herein have a separation layer (e.g., insulating layer)”)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the device as disclosed by Chang in view of Mayer with the insulation around the electrodes as disclosed by Zemel the motivation being to limit undesirable electrochemical reactions ([Column 17 lines 17-20])
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chang in view of Mayer further in view of Stern (US 6413255 B1) herein referred to as “Stern”.
Regarding claim 12, Chang in view of Mayer disclose: The device of claim 1. Chang does not disclose: wherein the distal portion of a device head of the device is at least partially formed of an adaptable/flexible material to conform to irregular topographies when the plurality of electrodes are pressurized such that a tissue engaging surface of each of the plurality electrodes abuts the tissue surface to maintain the electrical environment.
However, Stern discloses: wherein the distal portion of a device head of the device is at least partially formed of an adaptable/flexible material to conform to irregular topographies when the plurality of electrodes are pressurized such that a tissue engaging surface of each of the plurality electrodes abuts the tissue surface to maintain the electrical environment. ([Column 8 lines 35-38]; “In a related embodiment shown in FIG. 10b, electrode 16 is attached to a dielectric layer or film 32', which can be made of a conformable material that conforms to the surface of the skin”)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the device as disclosed by Chang in view of Mayer with the flexible end portion as disclosed by Stern the motivation being to conform to the surface of the skin.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chang in view of Mayer further in view of Goshgarian et al. (US 20120136350 A1) herein referred to as “Goshgarian”)
Regarding claim 16, Chang in view of Mayer disclose: The device of claim 1. Chang does not disclose: further comprising a shaft on to which the distal portion is mounted, wherein the shaft is connected to the distal portion by means of a ball and socket joint.
However, Gosghgarian discloses: further comprising a shaft on to which the distal portion is mounted ([Figure 25V]; Goshgarian discloses a handle 200 which the actuator is attached), wherein the shaft is connected to the distal portion by means of a ball and socket joint. ([0379]; “In one representative embodiment, as shown in FIG. 25V, the actuator 260 of handle assembly 200 comprises a ball- and socket joint”)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the device as disclosed by Chang in view of Mayer with the ball and socket joint as disclosed by Goshgarian the motivation being for controlled multi-direction deflection. ([0379])
Claim(s) 17, 19, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pearson (US 9895189 B2) herein referred to as “Pearson” in view of Mayer.
Regarding claim 17, Pearson discloses: A method for killing microbial contaminants ([Column 1 lines 16-21]; “The present invention relates to methods of treating infections in mammals using irreversible electroporation (IRE) to destroy the pathogenic microorganisms comprising the infection and methods of sterilization of implanted medical devices using IRE.”), comprising the steps of: providing, by a plurality of electrodes ([Column 5 lines 58-61];” In the embodiment shown, each probe 22 includes either a monopolar electrode or bipolar electrodes having two electrodes separated by an insulating sleeve”), a pulsed electric field, PEF, signal on a tissue surface in a vicinity of microbial contaminants ([Column 5 lines 6-10]; “ A probe comprising at least one electrode is adapted to receive from a voltage generator a plurality of electrical pulses in an amount sufficient to cause destruction of cells comprising the infection”), wherein the PEF penetrates beneath the tissue surface ([Column 31 lines 42-44]; “This last step can be repeated until a desired number of ablation pulses is delivered to the tissue”);. Pearson does not disclose: determining, by at least one impedance sensor, PEF parameters to deliver a desired electric field; and adjusting, by a controller, one or more parameters of the PEF signal in response to detecting by the at least one impedance sensor an impedance value or a change in impedance, to deliver the desired electric field for killing the microbial contaminants and wherein the plurality of electrodes comprise a return electrode and a terminal electrode, and wherein the controller is configured to switch a polarity of the return electrode and the terminal electrode.
However, Mayer discloses: determining, by at least one impedance sensor([0177]:” the therapeutic device comprises at least one sensory device (‘sensor’) selected from: a temperature sensor, a heart rate sensor, an EMG head, an ECG head, a pressure sensor, a voltage sensor, an imaging head, a current sensor, an impedance sensor”), PEF parameters to deliver a desired electric field; and adjusting, by a controller, one or more parameters of the PEF signal in response to detecting by the at least one impedance sensor an impedance value or a change in impedance, to deliver the desired electric field for killing the microbial contaminants. ([0465];” A system of the invention (e.g. as detailed in Example 1) is provided, wherein the control instructions contain the specifications of energy parameters (e.g. power, voltage, waveshape, duty cycle, frequency, pulse frequency, pulse duration, impedance targets, and power adjustments to apply in response to impedance changes”) wherein the controller is configured to adjust an electric field strength of the PEF signal using a computer implemented artificial intelligence algorithm based on real-time data such as impedance, temperature, pressure and distance between electrodes ([0589]; “the imaging console sends data to the energy generator console, e.g. spatial and tissue characterization information back to the energy delivery system. In this example, the energy generator console optionally uses this data in combination with the unique parameters of the energy delivery head to control the energy generator, e.g. by adjusting treatment energies and/or selecting or modifying predictive algorithms appropriately.”)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method as disclosed by Pearson with the sensors and predictive algorithm as disclosed by Mayor the motivation being to sense an environmental effect at a target site ([0176]) and to detect contact of electrodes ([0589]) respectively.
Regarding claim 19, Pearson in view of Mayer disclose: The method of claim 17. Mayor further discloses: further comprising the step of changing, by a controller, one or more parameters of the PEF signal in response to determining electrical properties of tissue to deliver the desired electric field for killing the microbial contaminants ([0329]; “Optionally, the algorithm is configured for controlling one or more output devices based on the input from one or more input devices. For example, the algorithm can comprise a step of controlling an output device (e.g. energy generator such as RF generator or fluid pump or a user output device such as a UI) that is dependent or triggered by the input from a sensor (e.g. temperature sensor, ECG, or impedance sensor).”)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method as disclosed by Pearson in view of Mayor with the method of output device control further disclosed by Mayor the motivation being to control energy delivered ([0329])
Regarding claim 20, Pearson in view of Mayer disclose: The method of claim 17. Mayer further discloses: further comprising the step of reversing a polarity of a pair of the electrodes during use. ([0190];” A head may optionally contain a plurality of electrodes which alternate polarity, phase, or connectivity to provide selective treatment.”)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the device as disclosed by Pearson in view of Mayor with the sensors further disclosed by Mayer the motivation being to provide selective treatment ([0190])
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pearson in view of Mayer further in view of Zemel.
Regarding claim 18, Pearson in view of Mayer disclose: The method of claim 17. Pearson does not disclose: further comprising the step of determining electrical properties of tissue based on an impedance value detected by the at least one impedance sensor.
However, Zemel discloses: further comprising the step of determining electrical properties of tissue based on an impedance value detected by the at least one impedance sensor. ([0025];” The continuity sensor can be adapted and configured to measure the impedance of tissue which the sensor is in contact with.”, wherein impedance is seen as an electrical property)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method as disclosed by Pearson in view of Mayer with the impedance sensing step as disclosed by Zemel the motivation being to determine if the electrode is in contact with the tissue ([0025]
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kalghatgi in view of Mayer.
Regarding claim 22, Kalghatgi discloses: The method of claim 21. Kalghatgi does not disclose: further comprising the steps of: detecting, by an impedance sensor, an impedance value or a change in impedance; and changing one or more parameters of the PEF signal in response to detecting the impedance value or the change in impedance. further comprising the steps of: detecting, by an impedance sensor, an impedance value or a change in impedance; and changing one or more parameters of the PEF signal in response to detecting the impedance value or the change in impedance.
However, Mayer discloses: further comprising the steps of: detecting, by an impedance sensor([0177];” the therapeutic device comprises at least one sensory device (‘sensor’) selected from… … an impedance sensor”), an impedance value or a change in impedance; and changing one or more parameters of the PEF signal in response to detecting the impedance value or the change in impedance.([0282]” Optionally, the control instructions comprise one or more energy output parameters of electroporation energy.” Wherein electroporation is seen as PEF signal and [0465];” A system of the invention (e.g. as detailed in Example 1) is provided, wherein the control instructions contain the specifications of energy parameters (e.g. power, voltage, waveshape, duty cycle, frequency, pulse frequency, pulse duration, impedance targets, and power adjustments to apply in response to impedance changes)”)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the device as disclosed by Kalghatgi with the impedance sensors and change in energy output based on impedance changes as disclosed by Mayer the motivation being to detect contact of electrodes ([0466])
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kalghatgi in view of Pearson.
Regarding claim 23, Kalghatgi discloses: The method of claim 21. Kalghatgi does not explicitly disclose: further comprising the step of providing a PEF signal to create pores in cell membranes and enhance delivery of therapies to cells.
However, Pearson disclose: further comprising the step of providing a PEF signal to create pores in cell membranes and enhance delivery of therapies to cells. ([Column 32 lines 36-38 ];” Alternatively, electrical pulses may be administered within a reversible electroporation range. Temporary pores will form in the cellular membranes of infectious cells.”
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the device as disclosed by Kalghatgi with the pore creation in cell membranes the motivation being to destroy infectious cells ([Column 32 lines 30-33])
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chang in view of Mayer further in view of Lorenzo (US 20210023362 A1)
Regarding claim 24 Chang in view of Mayer disclose: The device of claim 1. Chang does not disclose: configured to determine electrical properties of tissue based on an impedance value detected by the at least one impedance sensor, and/or the controller being configured to change one or more parameters of the PEF signal in response to determining electrical properties of tissue to deliver the desired electric field for killing the microbial contaminants.
However, Lorenzo discloses: configured to determine electrical properties of tissue based on an impedance value detected by the at least one impedance sensor ([0043];” is a system comprising: one or more probe(s) providing functionality for: delivering a plurality of electrical pulses to a tissue; and measuring electrical impedance relating to the tissue”, and/or the controller being configured to change one or more parameters of the PEF signal in response to determining electrical properties of tissue to deliver the desired electric field for killing the microbial contaminants. ([0205];” The present invention includes computer software (treatment monitoring module 54) which assists a user to plan for, execute, and review the results of a medical treatment procedure, as will be discussed in more detail below. For example, the treatment monitoring module 54 assists a user to plan for a medical treatment procedure by enabling a user to more accurately position each of the probes 22 of the therapeutic energy delivery device 20 in relation to the tissue, ROI, or lesion 300 in a way that will generate the most effective treatment zone, and/or provide options for the practitioner/user concerning whether and how to adjust treatment, and/or halt or stop treatment based on the impedance changes being measured by way of the diagnostic and/or therapeutic FAST monitoring”)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the device as disclosed by Chang in view of Mayer with the impedance monitoring technique as disclosed by Lorenzo the motivation being to provide the most effective treatment ([0205])
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chang in view of Mayer further in view of Dhillion et al. (US 20140121728 A1).
Regarding claim 25, Chang in view of Mayer disclose: The device of claim 1. Chang does not disclose: wherein the device comprises a memory pre-programmed with PEF parameters for electric field delivery based on natural tissue impedance and topography and wherein the controller is configured to change the one or more parameters of the PEF signal in response to determining the impedance of a tissue environment from the impedance sensor(s).
However, Mayer discloses: wherein the controller is configured to change the one or more parameters of the PEF signal in response to determining the impedance of a tissue environment from the impedance sensor(s). ([0465]; “A system of the invention (e.g. as detailed in Example 1) is provided, wherein the control instructions contain the specifications of energy parameters (e.g. power, voltage, waveshape, duty cycle, frequency, pulse frequency, pulse duration, impedance targets, and power adjustments to apply in response to impedance changes)”)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the device as disclosed by Chang in view of Mayer with the impedance sensors and change in energy output based on impedance changes as further disclosed by Mayer the motivation being to detect contact of electrodes ([0466])
However, Dhillion disclose: wherein the device comprises a memory pre-programmed with PEF parameters for electric field delivery based on natural tissue impedance and topography ([0075]; “In some embodiments, an electroporation device memory (not shown) may store data such as tumor type, photographic record of tumor size, color, shape, tumor progression, therapeutic agent dosage, electroporation parameters, and needle insertion placement. In further embodiments, this data may be collected into the electroporation device memory and downloaded, e.g., periodically, via a wireless connection to a cloud storage database (not shown).”)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the device as disclosed by Chang in view of Mayer with the preloaded memory as disclosed by Dhillion the motivation being to instruct future protocols ([0075])
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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/CASEY GEORGE CHA/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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