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 .
Information Disclosure Statement
The information disclosure statement(s) filed on the record are in compliance with the content requirements of 37 CFR 1.97 and 37 CFR 1.98 and have been considered.
Election/Restriction
Claims 1, 2, 5-10, 13-16, and 33-39 are currently pending and considered below.
Previous (now canceled) claims 19-22, 24, 25, 27 and 29 were withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/13/2026.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 160, 165, 180, 250, 255, 340, 1150, 1840 and 2140.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “130” has been used to designate two different structures in Fig. 1.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7, 9, 14 and all claims depending therefrom 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.
Regarding claim 7, the limitation "the discharge time constant for electrotransfer" lacks antecedent basis in the claims.
Regarding claim 9, the meaning of "discharge time constant" is unclear.
Regarding claim 14, the limitation "wherein the capacitive discharge circuit is housed within the housing is connected to the needle electrode array, and a fluid communication path is formed through the housing between the therapeutic reservoir and the lumen of the needle electrode" is unclear because the "housing" is recited functionally (i.e., the claim recites a first part incorporating the therapeutic reservoir and therapeutic delivery actuator is provided by a syringe connectable to a second part comprising an electrotransfer module having a housing).
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 7, 8, 9 and 13 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claim 7, the limitation "wherein capacitive discharge circuit parameters are matched to resistivity parameters of a therapeutic solution for electrotransfer to minimise total charge delivered and optimise the discharge time constant for electrotransfer" does not impart either a structural or a functional limitation on the claimed invention.
Regarding claim 8, the limitation "wherein capacitance of the capacitive discharge circuit is chosen based on a predicted total resistivity during discharge and a target accumulative charge, and the predicted total resistivity is based on the therapeutic solution resistivity" does not impart either a structural or a functional limitation on the claimed invention.
Regarding claim 9, the limitation "wherein the matching is to achieve a discharge time constant of between 20 ps and 2 s" does not impart either a structural or functional limitation on the claimed invention
Regarding claim 13, the limitation "wherein the reservoir is filled with a therapeutic solution prior to charging the capacitive discharge circuit" does not appear to impart a structural or functional limitation to the claimed invention; additionally, the claimed invention does not require charging a capacitive discharge circuit.
Claim Rejections - 35 USC § 102
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 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.
Claims 1, 5 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kjeken et al (U.S. Pub. 20110009807 A1, hereinafter "Kjeken").
Regarding claim 1, Kjeken discloses an electrotransfer system comprising:
at least one probe, each probe comprising:
a probe body (see Fig. 17A, showing a probe with a distal end; the unshown portion of the probe proximal to the distal end is a probe body);
a needle electrode array extending from the probe body configured as a needle to be inserted into tissue to be treated (see Fig. 17A, showing the distal end of the probe, comprising an electrode "c", insulation "b" and electrode "a"),
and a capacitive discharge circuit connected to the needle electrode array comprising capacitive charge storage configured to store a quantum of charge (see paras [0084]-[0085], disclosing an electronic circuit, connected to the electrode, that comprises a capacitor that can store sufficient energy and voltage for supply to the electrode),
and a switch actuatable to cause discharge of the stored quantum of charge through the needle electrode array (see para [0086], disclosing a 100 ms pulse of predetermined voltage; the application of voltage is implicitly a switch that turns on to provide the pulse, and then off to stop the pulse),
the needle electrode array incorporating at least two electrodes (see positive electrode and negative electrode in Fig. 17A), each electrode having a surface area substantially circumferential to the needle and exposed to directly contact tissue into which the needle electrode array is inserted (i.e., both electrodes "c" and "a" are capable of insertion into the tissue), with an insulating section "b" (see Fig. 17) between neighbouring electrodes to form a contiguous linear array structure, the exposed surface area of each electrode being at a different distance from the needle electrode array tip (i.e., the electrode "c" is further from the tip than the electrode "a"), each electrode connected to the capacitive discharge circuit for driving as an anode or cathode during discharge of the quantum of charge (both electrodes are connected to the capacitor), and wherein electrode length and length of the insulating section between neighbouring electrodes are configured to produce a target electric field shape in tissue adjacent to the array during discharge of the quantum of charge via the array (implicit in the design of Fig. 17A);
and a charging station having a DC power supply module (see para [0023], disclosing a battery-charging type unit, which is interpreted to provide DC power to the discharge circuit), output terminals connectable to a probe to form electric contact to the capacitive discharge circuit (implicit in order to provide charge from the battery charging type unit to the capacitive discharge circuit discussed above), and charging control circuitry to control charging of the capacitive discharge circuit of the connected probe (i.e., the discharge circuit itself, discussed above).
Regarding claim 5, Kjeken disclose the electrotransfer system as claimed in claim 1, wherein the electrodes are relatively elongate, wherein the electrode diameter is less than the electrode length (see Fig. 17A, showing elongate electrodes having a smaller diameter than their length).
Regarding claim 9, the limitation "wherein the matching is to achieve a discharge time constant of between 20 ps and 2 s" does not impart either a structural or functional limitation on the claimed invention. Even so, Kjeken discloses that the discharge time can be 100 ms (see para [0086]).
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.
Claims 2, 10, 14, 15, 33, 34 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Kjeken in view of Zhang et al (U.S. Pub. 2006/0036210 A1, hereinafter "Zhang").
Regarding claim 2, it is noted that Kjeken does not appear to disclose that the capacitive discharge circuit is housed in the probe body, and further comprising a switch actuator carried on the probe body configured to enable actuation of the capacitive discharge circuit switch.
Zhang discloses a modular electroporation probe, comprising a probe body (see Figs. 2 and 3A), with a capacitive discharge circuit disposed therein and a switch actuator carried on the probe body for enabling actuation of a capacitive discharge circuit switch (see Fig. 3A showing switches 102, and para [0083] disclosing button switches 102 that create a closed circuit between a pulse generator and attached electrodes; therefore, the circuit is understood to be within the housing).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Kjeken according to the teaching in Zhang, as the claimed probe body design was well-known at the time of the invention for providing control over an electrotransfer system in an improved ergonomic fashion (see Zhang at para [0083]), and could have been implemented in the invention of Kjeken with a reasonable expectation of success.
Regarding claims 10 and 36, Kjeken discloses the electrotransfer system as claimed in claim 1, where the probe body further comprises a therapeutic reservoir and a lumen through the needle in fluid communication with the therapeutic reservoir to hold a volume of fluid (see para [0020], disclosing delivering fluid therapeutic substance through side ports in the electrode through the electrode body), but does not appear to disclose a therapeutic delivery actuator operable to cause the fluid to be forced from the therapeutic reservoir and through the lumen and be discharged from the needle, wherein the therapeutic delivery actuator is further configured to activate the switch.
Zhang discloses a modular electroporation probe, comprising a therapeutic delivery actuator 100 (see Figs. 2 and 3A), which is operable to cause therapeutic fluid to be forced from a therapeutic reservoir and through a fluid to be discharged from an electrode needle (see para [0084]), and the actuator is configured to activate a switch 102 located thereon (i.e., the actuator is a handle that can be controlled by a user and a switch on the actuator 100 can be pressed to actuate a closed circuit between a generator and an electrode probe, as discussed in para [0083]).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Kjeken according to the teaching in Zhang, as the claimed actuator handle design was well-known at the time of the invention for providing control over an electrotransfer system in an improved ergonomic fashion (see Zhang at para [0083]), and could have been implemented in the invention of Kjeken with a reasonable expectation of success.
Regarding claim 14, Kjeken does not appear to disclose the electrotransfer system as claimed in claim 10, wherein the probe body has a two part form, wherein a first part incorporating the therapeutic reservoir and therapeutic delivery actuator is provided by a syringe (the recitation "connectable to a second part comprising an electrotransfer module having a housing adapted to engage with the syringe, and support the needle electrode array projecting outward from the housing, wherein the capacitive discharge circuit is housed within the housing is connected to the needle electrode array, and a fluid communication path is formed through the housing between the therapeutic reservoir and the lumen of the needle electrode" is recited as intended use of the syringe, and is not a positively recited structural feature).
Zhang discloses a modular electroporation probe, comprising a two-part body, with a first part incorporating a therapeutic reservoir and an actuator provided by a syringe (see Fig. 2 and 3A, showing actuator 130 provided by syringe 104); and the first part is capable of being connected to a second part (such as handle 100); the recitation "comprising an electrotransfer module having a housing adapted to engage with the syringe, and support the needle electrode array projecting outward from the housing, wherein the capacitive discharge circuit is housed within the housing is connected to the needle electrode array, and a fluid communication path is formed through the housing between the therapeutic reservoir and the lumen of the needle electrode" recites the intended use of the second part that is not required to be a part of the claimed invention; even so, Zhang discloses switches 102 on the housing used to provide a closed circuit between a pulse generator and electrodes; see para [0083]).
Further, regarding claim 15, the limitation "wherein the electrotransfer module housing is Luer-lock compatible to engage with a convention Luer syringe" is similarly a recitation of the intended use of the second part that is not required to be part of the claimed invention. In this case, the first part is capable of being connected to a second part having a housing that is Luer-lock compatible.
Accordingly, regarding claims 14 and 15, a skilled artisan would have found it obvious at the time of the invention to modify the device of Kjeken according to the teaching in Zhang, as the claimed actuator handle design was well-known at the time of the invention for providing control over an electrotransfer system in an improved ergonomic fashion (see Zhang at para [0083]), and could have been implemented in the invention of Kjeken with a reasonable expectation of success.
Regarding claims 33 and 34, it is noted that Kjeken does not appear to disclose the electrotransfer system as claimed in claim 1, further comprising a switch actuator carried on the probe body configured to enable actuation of the capacitive discharge circuit switch.
Zhang discloses a modular electroporation probe, comprising a probe body (see Figs. 2 and 3A), with a capacitive discharge circuit disposed therein and a switch actuator carried on the probe body for enabling actuation of a capacitive discharge circuit switch (see Fig. 3A showing switches 102, and para [0083] disclosing button switches 102 that create a closed circuit between a pulse generator and attached electrodes; therefore, the circuit is understood to be within the housing).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Kjeken according to the teaching in Zhang, as the claimed probe body design was well-known at the time of the invention for providing control over an electrotransfer system in an improved ergonomic fashion (see Zhang at para [0083]), and could have been implemented in the invention of Kjeken with a reasonable expectation of success.
Claims 6, 16 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Kjeken.
Regarding claim 6, it is noted that Kjeken does not appear to disclose the electrotransfer system as claimed in claim 5, wherein the electrodes have a length of 1mm or less.
However, Kjeken teaches another embodiment in which an electrode has a length of 0.1 cm (0.5 mm) up to 3 cm (30 mm) (see para [0065]).
A skilled artisan would have found it obvious at the time of the invention to choose the length of the electrodes to have a length of 1 mm or less, for instance, 0.5 mm up to 1 mm, as taught in Kjeken, with a reasonable expectation of success.
Regarding claim 16, Kjeken discloses the electrotransfer system as claimed in claim 1, wherein the needle electrode comprises:
a first needle which also acts as a first electrode (see Fig. 17A, electrode "a");
a first concentric insulator "b" (see Fig. 17A) sheathing the first needle to a predetermined first distance (L1) from the needle tip, a concentric second electrode "c" (see Fig. 17A) sheathing the first concentric insulator to a distance (L2) from a tipward end of the first concentric insulator, wherein the first needle and second concentric electrode are formed of conductive material and are electrically connected to positive and negative terminals of the capacitive discharge circuit (see positive and negative charges associated with each electrode "a" and "c") wherein the exposed length L1 of the first needle operates as a first electrode of a linear array, and an exposed length L3 of the second concentric electrode acts as the second electrode of a linear array (i.e., the electrode "a" spans L1 while the second electrode "c" spans L3).
It is noted that Kjeken does not appear to disclose a second concentric insulator sheathing the second electrode to the distance (L3) from a tipward end of the second electrode.
But Kjeken also teaches that it may be desirable to have an electrode with insulation that permits focusing of sensing to a specific region of tissue where the electrode is exposed (see para [0046]).
Accordingly, a skilled artisan would have found it obvious at the time of the invention to modify the invention of Kjeken so that a second concentric insulator sheathing the second electrode to the distance (L3) from a tipward end of the second electrode, in order to permit focusing of the sensing capability of the second electrode to a specific region of tissue where the electrode is exposed, with a reasonable expectation of success.
Regarding claim 38, Kjeken discloses that the exposed length L1 of the first needle (i.e., electrode "a") operates as a first electrode of a linear array, and the exposed length L3 of the second concentric electrode acts as the second electrode (i.e., electrode "c") of a linear array (see the linear array in Fig. 17A).
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Kjeken, in view of Nathanson (U.S. Pub. 2011/0054566, hereinafter "Nathanson").
Regarding claim 35, it is noted that Kjeken does not appear to disclose the electrotransfer system as claimed claim 1, wherein the charging station includes a probe mounting to support the probe during charging.
Nathanson discloses an electrotransfer system, comprising a charging station including a probe mounting to support the probe during charging (see Fig. 1, charging cradle 3).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Kjeken according to the teaching in Nathanson, in order to enable a battery within the device to be charged without removing the battery (see Nathanson at para [0036]).
Claims 37 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Kjeken, in view of Zhang, further in view of Dev et al (U.S. Pub. 2002/0099323, hereinafter "Dev").
Regarding claim 37, it is noted that the combination of Kjeken and Zhang does not appear to disclose the electrotransfer system as claimed in claim 10, wherein the probe is packaged with a therapeutic solution stored within the reservoir.
Dev teaches an electrode kit having a microneedle electrode array with integrated container for therapeutic agent and a therapeutic agent injector needle (see Fig. 12 and para [0043]).
A skilled artisan would have found it obvious at the time of the invention to modify the combination of Kjeken and Zhang, according to the teaching in Dev, in order to integrate the therapeutic solution reservoir with the rest electrotransfer system, for improving packaging, shipment and storage with a reasonable expectation of success.
Regarding claim 39, the combination of Kjeken, Zhang and Dev discloses the electrotransfer system as claimed in claim 37, wherein the respective lengths of the first and second electrodes, and exposed length of the first insulating portion therebetween determines the pattern of electric field gradients generated adjacent the needle array when an electric pulse is applied to drive one electrode as an anode and the other electrode as a cathode (this is interpreted to be inherent in the first and second electrodes having opposing polarities with the insulating section between them; this polarity generates a pattern of electrode field gradients adjacent the needle array upon an electric pulse; see also para [0108] discussing a pulsed electric field).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See Notice of References Cited.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SCOTT J MEDWAY whose telephone number is (571)270-3656. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM.
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/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783 04/17/2026
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