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 .
Election/Restrictions
Applicant’s election without traverse of Group I and Species A (Figs. 2-3) in the reply filed on 9/8/2026 is acknowledged.
Claims 12-14, 18-29, 36-37 and 39-56 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/8/2026. Claims 12-14 are drawn to non-elected embodiment in Figs 4-5 and claims 36-37 are drawn to non-elected embodiment in Fig. 11.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 2/27/2024, 4/10/2024, and 6/12/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 9, and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Belsky et al. (US 2008/0188837; hereafter Belsky).
Regarding claim 1, Belsky discloses a system for treating infected tissue (see para [0277]), the system comprising: an applicator device comprising an electrode pair (16) spaced apart and operable to be positioned against infected tissue (para [0092]-[0096], [0262]; [0277], [0331]); and an electrical power supply (12) operable to apply an electric field across the electrode pair to apply a pulsed electric field through the infected tissue, wherein the pulsed electric field has a field strength within a range that when the pulsed electric field is applied, pores are formed in membranes of cells of the infected tissue (para [0092]-[0096], [0114], [0262]; [0277], [0331]).
Regarding claim 2, Belsky discloses the system of claim 1, further comprising: an antimicrobial agent operable to cross or integrate into the membrane of the cells when the electric field is applied (para [0092]-[0096], [0234], [0277], [0401], [0436], [0479]).
Regarding claim 3, Belsky discloses the system of claim 2 comprising: at least one of an antibiotic, an antiseptic or an antifungal agent operable to cross or integrate into the membrane of the cells when the electric field is applied (para [0092]-[0096], [0234], [0277], [0401], [0436], [0479]).
Regarding claim 9, Belsky discloses the system of claim 1, wherein the electrodes are spaced apart at a distance of a range of about 0.1 millimeters (mm) to 5 mm (para [0265], [0427], [0473]).
Regarding claim 10, Belsky discloses the system of claim 1, wherein the field strength of the pulsed electric field is about 40 kilovolts per centimeter or less (para [0093], "a signal that creates a field that is less than about 5 Volts/cm").
Claim(s) 1, 10, and 15-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hofmann (US 6,009,345).
Regarding claim 1, Hofmann discloses a system for treating infected tissue (see Abstract), the system comprising: an applicator device (80) comprising an electrode pair (88) spaced apart and operable to be positioned against infected tissue (see col. 7, lines 44-65); and an electrical power supply (82) operable to apply an electric field across the electrode pair to apply a pulsed electric field through the infected tissue, wherein the pulsed electric field has a field strength within a range that when the pulsed electric field is applied, pores are formed in membranes of cells of the infected tissue (see at least col. 8, lines 37-53).
Regarding claim 10, Hofmann discloses the system of claim 1, wherein the field strength of the pulsed electric field is about 40 kilovolts per centimeter or less (see col. 8, lines 45-49).
Regarding claim 15, Hofmann discloses wherein the applicator device comprises: a wand (94, 96) having a handle (94) and a head (96 including 86), wherein the electrode pair are disposed in a distal end of the head (see Fig. 5) ; and wherein, the wand is operable to be grasped by the handle by a user and the distal end of the head is operable to be pressed by the user against the infected tissue (functional limitation; device is capable of being handled in recited manner).
Regarding claim 16, Hofmann discloses wherein the electrode pair comprises a plurality of parallel electrode pairs spaced a substantially equal distance apart (see Figs. 1A-1B).
Regarding claim 17, Hofmann discloses wherein the distal end of the head comprises at least one of a convex shape, a concave shape or a flat surface shape (see Figs. 5-6).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 4, 11, 30-32, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Belsky.
Regarding claim 4, Belsky teaches the system of claim 3, but does not explicitly teach wherein a microorganism inactivation rate of the at least one of an antibiotic, an antiseptic or an antifungal agent is greater when the pulsed electric field and antimicrobial agent are applied simultaneously than when the pulsed electric field and antimicrobial agent are applied separately. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to observe applying the antibiotic during application of pulsed electric field is more effective at microorganism inactivation rate than when the are applied separately by routine experimentation because Belsky teaches the antibiotics enter the infected cells upon poration by the pulsed electric field (para [0092]-[0096]; para [0103], "electrically-assisted drug-delivery facilitation system comprises electrical means to enhance the absorption of a drug contained in a commercially-available drug pill that is ingested by a patient in conjunction with ingesting the drug-delivery system, e.g., before, simultaneously with, or after ingesting the system"; para [0114]; para [0277]).
Regarding claim 11, Belsky teaches the system of claim 1, but does not explicitly teach wherein the pulsed electric field is comprised of a plurality of electric field pulses having a time duration of about 50 to 900 nanoseconds. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the time duration of pulses wherein the pulsed electric field is comprised of a plurality of electric field pulses having a time duration of about 50 to 900 nanoseconds by routine experimentation to optimize the poration (para [0128], "In an embodiment, the control component is adapted to drive the first and second electrodes to apply the series of pulses with a pulse duration of between about 0.5 milliseconds and about 1.5 milliseconds").
Regarding claim 30, Belsky teaches a system for treating infected tissue (para [0277]), the system comprising: an applicator device comprising an electrode pair (16) spaced apart and operable to be positioned against the infected tissue (para [0092]-[0096], [0262]; [0277], [0331]); and an electrical power supply (12) operable to generate an electric field having a field strength of 40 kV/cm or less across the electrode pair to apply a pulsed electric field being comprised of a plurality of electric field pulses (para [0093], "a signal that creates a field that is less than about 5 Volts/cm"; para [0092]-[0096], "the present invention, the drug-delivery system comprises an electrical signal generator and at least two electrodes, a signal that creates a field... typically using high voltage, creates transient permeable structures or micropores in the epithelial cell membranes"; para [0114], "a control component, adapted to facilitate passage of the drug, in response to a change of state of the environmentally-sensitive mechanism, through an epithelial layer of the GI tract by driving the first and second electrodes to apply a series of pulses"), wherein the pulsed electric field has a field strength within a range that when the pulsed electric field is applied, pores are formed in membranes of cells of the infected tissue (para [0092]-[0096], "the present invention, the drug-delivery system comprises an electrical signal generator and at least two electrodes a signal that creates a field a signal capable of opening tight junctions of the epithelial layer of the GI tract to an extent sufficient to allow at least a 100% increase in the passage of a drug therethrough.. Alternatively or additionally, the electrotransport includes any one of, or a combination of, iontophoresis, electroosmosis, and electrophoresis, which enhance diffusion processes through the epithelial cells, and/or electroporation. Electroporation is to be understood in the present application, including.. as electrotransport, which, typically using high voltage, creates transient permeable structures or micropores in the epithelial cell membranes"; para [0114], "a control component, adapted to facilitate passage of the drug, in response to a change of state of the environmentally-sensitive mechanism, through an epithelial layer of the GI tract by driving the first and second electrodes to apply a series of pulses"; para [0277]); and an antimicrobial agent operable to cross or integrate into the membrane of the cells when the pulsed electric field is applied (para [0092]-[0096], "the present invention, the drug- delivery system comprises an electrical signal generator and at least two electrodes.. a signal that creates a field... a signal capable of opening tight junctions of the epithelial layer of the GI tract to an extent sufficient to allow at least a 100% increase in the passage of a drug therethrough Alternatively or additionally, the electrotransport includes any one of, or a combination of, iontophoresis, electroosmosis, and electrophoresis, which enhance diffusion processes through the epithelial cells, and/or electroporation. Electroporation is to be understood in the present application, including as electrotransport, which, typically using high voltage, creates transient permeable structures or micropores in the epithelial cell membranes"; para [0277], "In an embodiment, the first drug includes a systemic antibiotic for treating an infection of the GI tract, and the second drug includes an agent for topical treatment of the infection"); but does not explicitly teach having a time duration of about 50 to 900 nanoseconds through the infected tissue.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the time duration of pulses wherein the pulsed electric field is comprised of a plurality of electric field pulses having a time duration of about 50 to 900 nanoseconds through the infected tissue by routine experimentation to optimize the poration (para [0128], "In an embodiment, the control component is adapted to drive the first and second electrodes to apply the series of pulses with a pulse duration of between about 0.5 milliseconds and about 1.5 milliseconds").
Regarding claim 31, Belsky teaches the system of claim 30, comprising: at least one of an antibiotic, an antiseptic or an antifungal agent operable to cross or integrate into the membrane of the cells when the pulsed electric field is applied (para [0092]-[0096], [0234], [0277], [0401], [0436], [0479]); but does not explicitly teach wherein a microorganism inactivation rate of the at least one of an antibiotic, an antiseptic or an antifungal agent is greater when the pulsed electric field and antimicrobial agent are applied simultaneously than when the pulsed electric field and antimicrobial agent are applied separately. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to observe applying the antibiotic during application of pulsed electric field is more effective at microorganism inactivation rate than when they are applied separately by routine experimentation because Belsky teaches the antibiotics enter the infected cells upon poration by the pulsed electric field (para [0092]-[0096]; para [0103], "electrically-assisted drug-delivery facilitation system comprises electrical means to enhance the absorption of a drug contained in a commercially-available drug pill that is ingested by a patient in conjunction with ingesting the drug-delivery system, e.g., before, simultaneously with, or after ingesting the system para [0114]; para [0277]).
Regarding claim 32, Belsky teaches the system of claim 30, wherein the pulsed electric field has an electric field strength of about 30 kV/cm or less (para [0093], "a signal that creates a field that is less than about 5 Volts/cm").
Regarding claim 35, Belsky teaches the system of claim 30, but does not explicitly teach wherein the concentration of antimicrobial agent is between 0.001 percent and 2.0 percent. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify amounts wherein the concentration of antimicrobial agent is between 0.001 percent and 2.0 percent by routine experimentation to optimize therapeutic effect.
Claim(s) 5-7 and 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over Belsky in view of Jones et al. (US 2018/0168490 A1; hereafter Jones).
Regarding claim 5, Belsky teaches the system of claim 2, but does not teach wherein the antimicrobial agent comprises a member of the biguanide family.
However, in an invention relating to treating GI tract, Jones teaches use of a biguanide (Jones para [0480], "Non- limiting examples of such agents for treating or preventing a gastrointestinal disorder... the antibiotic selected for treatment is selected from the group consisting of biguanides. Jones para [0579], "Examples of guanides, biguanides, biguanidines and triguanides that are currently been used as antibacterial agents include chlorhexidine").
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine these references and incorporate the biguanide as the antibiotic in Belsky by routine experimentation to optimize the GI tract of Belsky.
Regarding claim 6, Belsky teaches the system of claim 2, but does not teach wherein the antimicrobial agent comprises Chlorhexidine.
However, in an invention relating to treating GI tract, Jones teaches use of a Chlorhexidine (Jones para [0480], "Non-limiting examples of such agents for treating or preventing a gastrointestinal disorder. the antibiotic selected for treatment is selected from the group consisting of… biguanides.. Jones para [0579], "Examples of guanides, biguanides, biguanidines and triguanides that are currently been used as antibacterial agents include chlorhexidine").
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine these references and incorporate the Chlorhexidine as the antibiotic in Belsky by routine experimentation to optimize the GI tract of Belsky.
Regarding claim 7, Belsky in view of Jones teaches the system of claim 6, but does not explicitly teach wherein the concentration of antimicrobial agent is between 0.001 percent and 2.0 percent.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify amounts wherein the concentration of antimicrobial agent is between 0.001 percent and 2.0 percent by routine experimentation to optimize therapeutic effect.
Regarding claim 33, Belsky teaches the system of claim 30, but does not teach wherein the antimicrobial agent comprises a member of the biguanide family.
However, in an invention relating to treating GI tract, Jones teaches use of a biguanide (Jones para [0480], "Non-limiting examples of such agents for treating or preventing a gastrointestinal disorder. the antibiotic selected for treatment is selected from the group consisting of. biguanides Jones para [0579], "Examples of guanides, biguanides, biguanidines and triguanides that are currently been used as antibacterial agents include chlorhexidine").
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine these references and incorporate the biguanide as the antibiotic in Belsky by routine experimentation to optimize the GI tract of Belsky.
Regarding claim 34, Belsky teaches the system of claim 30, but does not teach wherein the antimicrobial agent comprises Chlorhexidine.
However, in an invention relating to treating GI tract, Jones teaches use of a orhexidine (Jones para [0480], "Non-limiting examples of such agents for treating or preventing a gastrointestinal disorder.. the antibiotic selected for treatment is selected from the group consisting of. biguanides. Jones para [0579], "Examples of guanides, biguanides, biguanidines and triguanides that are currently been used as antibacterial agents include chlorhexidine").
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine these references and incorporate the Chlorhexidine as the antibiotic in Bielsky by routine experimentation to optimize the GI tract of Belsky.
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Belsky or Hofmann in view of Landman et al. (US 2006/0025765 A1; hereafter Landman).
Regarding claim 8, Belsky or Hofmann teaches the system of claim 1, but does not teach further comprising: a bridging resistor electrically connected in parallel with the electrode pair to the power supply, wherein the bridging resistor substantially matches an impedance of a pulse generator that the power supply is connected to.
However, in a similar invention, Landman teaches a bridging resistor electrically connected with the electrode pair to the power supply, wherein the bridging resistor matches an impedance of a pulse generator that the power supply is connected to (Landman abstract, "An electrosurgical device includes: a plurality of electrodes"; Landman para [0133], "Operation 424 includes a time delay (TD). This time delay allows the impedance of the tissue (and therefore unknown resistor in the Wheatstone bridge) to change before the current is measured again at operation 4218, described below. The time delay can vary depending on voltage and current being applied to the tissue, electrode configuration. para [0143], "a plurality of electrodes in which the electrodes be controlled in accordance with impedance feedback according to one embodiment of the invention. As shown, each of the relays 500 is connected to the input and to a single output. A controller 502 can be connected to a voltage source from Ground to power components, MIC, and Bridges").
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine these references and incorporate the bridge resistor system wherein the bridging resistor is electrically connected in parallel with the electrode pair to the power supply, wherein the bridging resistor substantially matches an impedance of a pulse generator that the power supply is connected to by routine experimentation to optimize controlling the pulse delivered to the tissue of Belsky or Hofmann.
Claim(s) 15-17, 38, and 57-58 are rejected under 35 U.S.C. 103 as being unpatentable over Belsky in view of Hofmann.
Regarding claim 15, Belsky teaches the system of claim 1, but does not teach wherein the applicator device comprises: a wand having a handle and a head, wherein the electrode pair are disposed in a distal end of the head: and wherein, the wand is operable to be grasped by the handle by a user and the distal end of the head is operable to be pressed by the user against the infected tissue.
However, in a similar invention, Hofmann teaches an applicator device comprises: a wand (94, 96) having a handle (94) and a head (96 including 86), wherein the electrode pair are disposed in a distal end of the head (see Fig. 5) ; and wherein, the wand is operable to be grasped by the handle by a user and the distal end of the head is operable to be pressed by the user against the infected tissue (functional limitation; device is capable of being handled in recited manner).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine these references and incorporate the wand system as the applicator of Belsky by routine experimentation to provide different means of affixing the electrodes.
Regarding claim 16, Hofmann teaches wherein the electrode pair comprises a plurality of parallel electrode pairs spaced a substantially equal distance apart (see Figs. 1A-1B).
Regarding claim 17, Hofmann teaches wherein the distal end of the head comprises at least one of a convex shape, a concave shape or a flat surface shape (see Figs. 5-6).
Regarding claim 57, Hofmann teaches wherein the distal end of the head is a curved surface (see Fig. 5).
Regarding claim 58, Hofmann teaches wherein the distal end of the head is a flat surface (see Fig. 6).
Conclusion
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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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