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 Objections
Claim 11 is objected to because of the following informalities: Line 4: “a position” should read –and a position--.
Appropriate correction is required.
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 1-14 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 1, it is unclear if “a middle connector” in line 8 is a different middle connector from “a middle connector” in line 2. Clarity is needed. For examination purposes, they will be considered the same middle connector.
Regarding dependent claims 2-14, dependent claims inherit the deficiencies from the claims from which they depend and are similarly rejected over 35 U.S.C. 112(b).
Regarding claim 4, it is unclear what “V/cm 2” in line 3 of the claim means. Clarity is needed. For examination purposes, this will be considered “V/cm”.
Regarding claim 13, it is unclear if “a guide groove” in lines 3-4 is the same guide groove as “a guide groove” in line 2 of claim 11, or if these are two different guide grooves. Clarity is needed.
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 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.
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 1 is rejected under 35 U.S.C. 103 as being unpatentable over Mathieson et al., US 20040059285, herein referred to as “Mathieson”, in view of Kohoutek et al., US 20190388675, herein referred to as “Kohoutek”.
Regarding claim 1, Mathieson discloses a reversible electroporation system (Figure 1 and [0001]) including a middle connector (Figure 1: support block 4), the system comprising: a pulse generator (Figure 1: power source 18) configured to create an electric field to a target lesion by means of an electrode ([0100]: “Once the needles 6 have been retracted as described, the voltage source 18 is activated and electroporation proceeds with each of the needles 6 acting as an electrode. The electric field produced by the needles 6 acting as electrodes propagates into the muscle or body tissue to be treated via the apertures 16 formed along the length of the Teflon shields 14.”); at least one electroporator (Figure 1: needle assembly 2) configured to simultaneously supply a pulse and inject a drug into a target site ([0100]: “Once the needles 6 have been retracted as described, the voltage source 18 is activated and electroporation proceeds with each of the needles 6 acting as an electrode.” And [0096]); and a middle connector configured to mount the electroporator (Figure 1: support block 4 and [0096]) at a correct treatment position and adjust an insertion depth of the electroporator so that a procedure is performed stably ([0105]). Mathieson does not explicitly disclose a reversible electroporation system comprising a middle connector configured to adjust an insertion angle of the electroporator.
However, Kohoutek teaches a reversible electroporation system (Figure 2 and [0001]) comprising a middle connector (Figure 2: base support 215 and micromanipulator assembly 101) configured to adjust an insertion angle of the electroporator ([0019]: “The probe 201 is coupled to a rotational stage 203 by an extended arm 205. The rotational stage 203 is configured to controllably adjust an angular position of the micropipette/probe 201 to rotate into position for transfection and then away from the cell sample 107.”).
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 system disclosed by Mathieson so that the middle connector is configured to adjust an insertion angle of the electroporator as taught by Kohoutek so that the system can transfect different sized areas (Kohoutek [0024]).
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Mathieson in view of Kohoutek, further in view of Gruba et al., US 20190125788, herein referred to as “Gruba”.
Regarding claim 2, Mathieson in view of Kohoutek discloses the system of claim 1, and Mathieson further discloses a system wherein the middle connector comprises a container mounting part to which a container is fastened (Figure 2a: fluid container 10 is fastened to support block 4) and a pump mounting part to which a pump is fastened (Figure 2a: lever 24, vertical member 24, and cross piece 30 are fastened to pistons 12, which are a type of pump), and controls pump pressure and drug injection amount ([0101]-[0102]). Mathieson in view of Kohoutek does not explicitly disclose a system wherein the container is an ampoule.
However, Gruba teaches a system wherein the container is an ampoule ([0034]: “Calcium-ion-containing solutions may be stored, for example, in a syringe, vial, ampoule, bag, or other container (e.g., any container that is configured to interact with an electroporation balloon catheter as described elsewhere herein).”).
It would have been an obvious matter of design choice to one having ordinary skill in the art before the effective filing date of the claimed invention to use an ampoule as a container, since applicant has not disclosed that an ampoule solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with the container of Mathieson, as a fluid container and ampoule are equivalent in the art as taught by Gruba.
Regarding claim 3, Mathieson in view of Kohoutek and Gruba discloses the system of claim 2, and Mathieson further discloses a system wherein the pump mounting part is connected with the electroporator (Figure 2a: lever 24, vertical member 24, and cross piece 30 are connected to needle assembly 2 via support block 4), a power cable (Figure 2c: lever 24, vertical member 24, and cross piece 30 are connected to power supply 18 via support block 4), and a drug tube (Figure 2c: lever 24, vertical member 24, and cross piece 30 are connected to fluid container 10 via support block 4). Kohoutek discloses a system wherein the pump mounting part ([0003]: “The probe includes a micropipette configured to controllably dispense a transfection agent”; thus extended arm 205 is a pump mounting part since micropipette 201 includes a pump) is configured to be rotated at various angles to increase operator's freedom of treatment ([0019]: “The probe 201 is coupled to a rotational stage 203 by an extended arm 205. The rotational stage 203 is configured to controllably adjust an angular position of the micropipette/probe 201 to rotate into position for transfection and then away from the cell sample 107.”).
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 system disclosed by Mathieson so that the pump mounting part is configured to be rotated at various angles to increase operator's freedom of treatment as taught by Kohoutek so that the system can transfect different sized areas (Kohoutek [0024]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Mathieson in view of Kohoutek, further in view of Hoffman, US 6208893, herein referred to as “Hoffman”.
Regarding claim 4, Mathieson in view of Kohoutek discloses the system of claim 1, and Mathieson further discloses a system wherein the pulse generator transmits the pulses to the electroporator by means of the middle connector (Figure 1: power source 18 is connected to support block 4). Mathieson in view of Kohoutek does not explicitly disclose a system wherein the pulse generator generates pulses with an intensity ranging from 300 V/cm to 1,500 V/cm and a width of 1 µs to 200 µs.
However, Hoffman teaches a system wherein the pulse generator generates pulses with an intensity ranging from 300 V/cm to 1,500 V/cm and a width of 1 µs to 200 µs (Col. 6, lines 30-34).
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 system disclosed by Mathieson so that the pulse generator generates pulses with an intensity ranging from 300 V/cm to 1,500 V/cm and a width of 1 µs to 200 µs as taught by Hoffman so that electroporation occurs without damaging significant numbers of normal or healthy cells (Hoffman Col. 6, lines 18-20).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Mathieson in view of Kohoutek, further in view of Kjeken et al., US 20070287950, herein referred to as “Kjeken”.
Regarding claim 5, Mathieson in view of Kohoutek discloses the system of claim 1, and Mathieson further discloses a system wherein a needle of the electroporator (Figure 1: hollow needle 6) comprises: an internal hollow part that allows drug injection for reversible treatment ([0096]: “Each needle assembly 2 comprises a hollow needle 6 having a sharp end 8 which is open to allow the injection of fluids via the opening”). Mathieson in view of Kohoutek does not explicitly disclose a system wherein a needle comprises an electrode pattern part wound in parallel or spirally along an external surface of the needle.
However, Kjeken teaches system (Figure 14B) wherein a needle comprises an electrode pattern part wound in parallel or spirally along an external surface of the needle ([0028]: “FIG. 14B depicts electrodes in a spiral about the shaft.”).
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 system disclosed by Mathieson so that a needle comprises an electrode pattern part wound in parallel or spirally along an external surface of the needle as taught by Kjeken so that the needle can comprise sections with no exposed electrodes (Kjeken [0007]).
Claims 6-7 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Mathieson in view of Kohoutek, further in view of Rife et al., US 20190374740, herein referred to as “Rife”.
Regarding claim 6, Mathieson in view of Kohoutek discloses the system of claim 1, and Mathieson further discloses a system wherein the middle connector comprises: a seating part that has a streamlined shape at a portion in contact with a surface of a body (Figure 2a: contact member 20 and [0101]: “These means comprise a moveable skin contact 20 which contacts the skin S as shown in FIGS. 2a to c.”). Mathieson in view of Kohoutek does not explicitly disclose a system wherein the seating part is made of an anti-slip means to prevent slipping, so that the middle connector is seated at a specific location on the body without shaking, wherein the seating part comprises a belt fixing part that may be fixed to a chair or a treatment bed using a belt to minimize shaking or change in position of the middle connector due to external factors during the procedure.
However, Rife teaches a system (Figure 1)) wherein the middle connector (Figure 1: central support 130) comprises: a seating part that has a streamlined shape at a portion in contact with a surface of a body and is made of an anti-slip means to prevent slipping (Figure 1: planar base 110 and [0021]), so that the middle connector is seated at a specific location on the body without shaking ([0021]), wherein the seating part comprises a belt fixing part (Figure 6: lateral straps 610) that may be fixed to a chair or a treatment bed using a belt to minimize shaking or change in position of the middle connector due to external factors during the procedure ([0027]: “The length of the straps are selectively adjustable and the distal ends of the straps are secured to a receiving structure, such as a ring, or secured about a support structure such as around the leg of a hospital bed.”).
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 system disclosed by Mathieson so that the seating part is made of an anti-slip means to prevent slipping, so that the middle connector is seated at a specific location on the body without shaking, wherein the seating part comprises a belt fixing part that may be fixed to a chair or a treatment bed using a belt to minimize shaking or change in position of the middle connector due to external factors during the procedure as taught by Rife to provide further comfort to the patient (Rife [0021]).
Regarding claim 7, Mathieson in view of Kohoutek and Rife discloses the system of claim 6 but does not explicitly disclose a system wherein the anti-slip means is made of rubber or consists of a plurality of airbags capable of expansion and contraction to prevent slipping on the body and ensure a stable fixation.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the material of planar base 110 of Rife so that it is made or rubber, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. See also Ballas Liquidating Co. v. Allied industries of Kansas, Inc. (DC Kans) 205 USPQ 331.
Regarding claim 10, Mathieson in view of Kohoutek discloses the system of claim 1 but does not explicitly disclose a system wherein on a side of a main body housing of the middle connector, a guide groove is formed to adjust a position of a separate electroporator cradle.
However, Rife teaches a system wherein on a side of a main body housing of the middle connector, a guide groove is formed to adjust a position of a separate electroporator cradle (Figures 4A-C: groove 410 and [0024]; in combination with Mathieson the cradle is an electroporator cradle).
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 system disclosed by Mathieson so that on a side of a main body housing of the middle connector, a guide groove is formed to adjust a position of a separate electroporator cradle as taught by Rife so that the cradle can both freely travel along a groove and be locked in a specific position (Rife [0024]).
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Mathieson in view of Kohoutek, further in view of Krieger et al., US 20120203095, herein referred to as “Krieger”.
Regarding claim 8, Mathieson in view of Kohoutek discloses the system of claim 1 but does not explicitly disclose a system wherein inside a main body housing of the middle connector, a first mesh-type fixing part is provided to accurately position the electroporator at the treatment position.
However, Krieger teaches a system wherein inside a main body housing of the middle connector (Figure 10), a first mesh-type fixing part is provided to accurately position the electroporator at the treatment position (Figure 14D and [0098]).
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 system disclosed by Mathieson so that inside a main body housing of the middle connector, a first mesh-type fixing part is provided to accurately position the electroporator at the treatment position as taught by Krieger so that needle insertion locations can be pre-planned using patient images to identify target tissue locations (Krieger [0098]).
Regarding claim 9, Mathieson in view of Kohoutek and Krieger discloses the system of claim 8, and Krieger further discloses a system wherein the first mesh- type fixing part is made of a conductive material and has at least one perforated hole (Figure 14D), so that an electric field may be applied through an electroporator needle or directly when touching a portion of a body ([0098] and in combination with Mathieson, the needle generates an electric field), and a drug may be applied directly to a skin surface (in combination with Mathieson, the needle delivers drugs).
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 system disclosed by Mathieson so that the first mesh- type fixing part is made of a conductive material and has at least one perforated hole as taught by Krieger so that needle insertion locations can be pre-planned using patient images to identify target tissue locations (Krieger [0098]).
Claims 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Mathieson in view of Kohoutek, Rife, and Krieger.
Regarding claim 11, Mathieson in view of Kohoutek discloses the system of claim 1 but does not explicitly disclose a system wherein a separate electroporator cradle is mounted in a guide groove, and the electroporator cradle includes a second mesh-type fixing part, an angle adjustment part, a position adjustment guide, wherein the electroporator is moved to an appropriate position by the position adjustment guide, the electroporator is adjusted or fixed to an angle required for the procedure by the angle adjustment part, and the electroporator is stably fixed using a through hole of the second mesh-type fixing part and a through hole of a first mesh-type fixing part.
However, Rife teaches a system wherein a separate electroporator cradle (Figures 4A-C: support assembly 400; in combination with Mathieson this cradle is an electroporator cradle) is mounted in a guide groove (Figures 4A-C: groove 410 and [0024]), and the electroporator cradle includes a second mesh-type fixing part (Figures 4A-C: the holes in support assembly are a mesh-type fixing part), an angle adjustment part (Figure 3), and a position adjustment guide (Figures 3-4C and [0029]), wherein the electroporator is moved to an appropriate position by the position adjustment guide (Figures 4A-C and [0029]), the electroporator is adjusted or fixed to an angle required for the procedure by the angle adjustment part (Figure 3 and [0029]), and the electroporator is stably fixed using a through hole of the second mesh-type fixing part (Figure 5)).
Further, Kriger teaches a system wherein the electroporator is stably fixed using a through hole of a first mesh-type fixing part (Figure 14D and [0098] and in combination with Mathieson, the needle of Krieger is an electroporator).
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 system disclosed by Mathieson so that a separate electroporator cradle is mounted in a guide groove, and the electroporator cradle includes a second mesh-type fixing part, an angle adjustment part, a position adjustment guide, wherein the electroporator is moved to an appropriate position by the position adjustment guide, the electroporator is adjusted or fixed to an angle required for the procedure by the angle adjustment part, and the electroporator is stably fixed using a through hole of the second mesh-type fixing part as taught by Rife so that the cradle can both freely travel along a groove and be locked in a specific position (Rife [0024]).
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 system disclosed by Mathieson so that the electroporator is stably fixed using a through hole of a first mesh-type fixing part as taught by Krieger so that needle insertion locations can be pre-planned using patient images to identify target tissue locations (Krieger [0098]).
Regarding claim 12, Mathieson in view of Kohoutek, Rife, and Krieger discloses the system of claim 11, and Mathieson further discloses a system wherein the electroporator cradle further comprises a height adjustment part capable of moving up and down to increase convenience for the procedure depending on a position of an operator or a patient (Figures 2a-2b: lever 24).
Regarding claim 13, Mathieson in view of Kohoutek, Rife, and Krieger discloses the system of claim 11, and Rife further discloses a system wherein the electroporator cradle has a shape that protrudes at intervals of 120 degrees in a circumferential direction (Figures 4A-C: support assembly 400 has four protrusions, and they protrude at intervals of 120 degrees and at other intervals; in combination with Mathieson the cradle is an electroporator cradle), and a guide groove is formed on an inside of the protruded shape (Figures 4A-C: groove 410 is on an inside of the protrusions of support assembly 400), so that the electroporator may move along the guide groove (Figures 4A-C), and a fastening groove is formed at an end of the guide groove to secure the at least one electroporator depending on an extent of the lesion (Figures 4A-B: tongue component 430 and push button 420).
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 system disclosed by Mathieson so that the electroporator cradle has a shape that protrudes at intervals of 120 degrees in a circumferential direction, and a guide groove is formed on an inside of the protruded shape, so that the electroporator may move along the guide groove, and a fastening groove is formed at an end of the guide groove to secure the at least one electroporator depending on an extent of the lesion as taught by Rife so that the cradle can both freely travel along a groove and be locked in a specific position (Rife [0024]).
Regarding claim 14, Mathieson in view of Kohoutek discloses the system of claim 1 but does not explicitly disclose a system wherein the middle connector consists of a circular middle connector including a first housing , a second housing, and a seating pad, wherein by using a third mesh-type fixing part provided on an inside of the first housing, and a fourth mesh- type fixing part provided on an inside of the second housing, a position of the electroporator may be stably adjusted, and the insertion angle and the insertion depth may also be adjusted.
However, Rife teaches a system wherein the middle connector consists of a circular middle connector (Figure 1: securable central support 130 and support assembly 140) including a first housing (Figure 1: securable central support 130), a second housing (Figures 4A-B: support assembly 400), and a seating pad (Figure 1: planar base 110), wherein by using a fourth mesh- type fixing part provided on an inside of the second housing ((Figures 4A-C: the holes in support assembly are a mesh-type fixing part)), a position of the electroporator may be stably adjusted ([0023]-[0024]), and the insertion angle and the insertion depth may also be adjusted ([0023]-[0024]).
Further, Kriger teaches a system wherein by using a third mesh-type fixing part provided on an inside of the first housing a position of the electroporator may be stably adjusted (Figure 14D and [0098] and in combination with Mathieson, the needle of Krieger is an electroporator).
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 system disclosed by Mathieson so that the middle connector consists of a circular middle connector including a first housing , a second housing, and a seating pad, wherein by using a fourth mesh- type fixing part provided on an inside of the second housing, a position of the electroporator may be stably adjusted, and the insertion angle and the insertion depth may also be adjusted as taught by Rife so that the cradle can both freely travel along a groove and be locked in a specific position (Rife [0024]).
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 system disclosed by Mathieson so that by using a third mesh-type fixing part provided on an inside of the first housing a position of the electroporator may be stably adjusted as taught by Krieger so that needle insertion locations can be pre-planned using patient images to identify target tissue locations (Krieger [0098]).
Conclusion
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/NORA W RHODES/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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