DETAILED ACTION
The following is a Non-Final Office Action on the merits.
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 .
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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/19/2026 has been entered.
Response to Amendment
Acknowledgment is made to the amendment received 2/19/2026.
Applicant’s amendments to claim 19 are sufficient to overcome the 35 USC 112(b)/second paragraph rejections set forth in the previous office action.
Claim Objections
Claim 1 is objected to because of the following informalities: amend “shape and position” to -its shape and a position-. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: amend “shape and position” to -its shape and a position-. Appropriate correction is required.
Claim 25 is objected to because of the following informalities: amend “space” to -spacer-. 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 4 & 18 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.
Claims 4 & 18 recite the limitation “conductivity of a tissue of the treatment area” which is regarded as indefinite as the claim(s), in light of the specification, fail(s) to specifically define the range of tissue, and conductivity of tissue can vary depending on tissue type and how the conductivity is measured. The specification discusses various tissue (“a treatment area 300 that may include skin or other tissue including heart, liver, or any other cell or tissue type to which treatment is to be applied“ ([0091]) or “For example, the treatment may be on skin, liver tissue, heart tissue, or any other type of tissue or cells.” ([0118] and gives a specific example conductivity range for epidermal tissue. However, since the type of tissue not limited to a specific type of tissue, one of ordinary skill in the art would be unable to determine the scope of the claim (e.g., what tissue conductivity to determine). Further, since conductivity is frequency dependent, one of ordinary skill in the art would be unable to determine the conductivity without the electrical parameters used to take the measurement.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-3, 7-9 & 15 is/are rejected under 35 U.S.C. 102(a)(1) or 102(a)(2) as being anticipated by Marenus et al. (9,566,430, previously cited).
Concerning claim 1, as illustrated in at least Fig. 2 and discussed in Col. 4-5, ll. 56-25, Marenus et al. disclose an electrode assembly for delivery of electrical therapy (topical or cosmetic system 10; Col. 1, ll. 10-19), the electrode assembly comprising:
at least two electrodes (first element 12 acts as a cathode and second element 14 acts as an anode) configured to deliver high voltage pulses generated by a pulse generator (first and second elements 12, 14 are capable of being connected to an appropriate power source to deliver high voltage pulses), each of the at least two electrodes comprising:
a conductive treatment surface configured to apply the electrical therapy to a treatment area (first and second elements 12, 14 have a surface that contacts skin surface 2), and
a conductive non-treatment surface configured to contact a conductive spacer (first and second elements 12, 14 have a surface that contacts third element 16 that electrically connects first and second elements 12, 14 together); and
the conductive spacer disposed between the at least two electrodes and configured to contact a surface of the treatment area between the at least two electrodes (third element 16 extends over a predetermined distance between elements 12, 14 and electrically connects first and second elements 12, 14 together and contacts a surface of the treatment area between the elements 12, 14), wherein:
a first portion of the conductive spacer is configured to electrically contact the conductive non-treatment surface of a first electrode of the at least two electrodes, a second portion of the conductive spacer is configured to electrically contact the conductive non-treatment surface of a second electrode of the at least two electrodes, (side surface of third element 16 physically and electrically contacts side surface of first and second elements 12, 14) and
the conductive spacer comprises a material having a consistency to maintain shape and position between the at least two electrodes (third element 16 material can be one of several materials, (e.g., hydrogels, conductive adhesives) having a consistency to maintain shape and position between elements 12, 14; Col. 7-8, ll. 46-19) and is configured to direct electric current into a tissue below the surface of the treatment area to improve uniformity and treatment depth (third element 16 is capable of this function when connected to an appropriate power source).
Concerning claim 2, Marenus et al. disclose the conductive spacer (16) comprises one of a hydrogel, a conductive adhesive, a conductive gel, a conductive silicone, a urethane rubber, thermoplastic, thermoset resin, or any combination thereof (Col. 7-8, ll. 46-19).
Concerning claim 3, Marenus et al. disclose the at least two electrodes (12, 14) are configured to deliver the electrical therapy between 1 kV/cm and 100 kV/cm when connected to an appropriate power source (see rejection of claim 1).
Concerning claim 7, Marenus et al. disclose the conductive treatment surface of the at least two electrodes (12, 14) electrically and/or directly contacts the treatment area (2) (Col. 4-5, ll. 56-25; Fig. 2).
Concerning claim 8, Marenus et al. disclose the at least two electrodes (12, 14) comprise bipolar electrodes (Col. 4-5, ll. 56-25; Fig. 2).
Concerning claim 9, Marenus et al. disclose at least one of the at least two electrodes (12, 14) comprise a surface electrode (12, 14) (Col. 4-5, ll. 56-25; Fig. 2).
Concerning 15, Marenus et al. disclose the conductive spacer (16) comprises a semi-conductive material and is configured to act as a parallel resistor (Col. 4-5, ll. 56-25, Col. 7-8, ll. 46-19; Fig. 2).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 3-6, 11 & 24-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marenus et al. (9,566,430, previously cited), as applied to claim 1.
Concerning claims 3-4, while Marenus et al. disclose examples of the conductive spacer (16) and the spacer (16) comprises a material or materials with sufficiently high electrical conductivity for generating the desired cross-flow microcurrent over the skin surface to achieve the effect of preventing or treating skin damage (Col. 2, ll. 43-52 & Col. 7, ll. 46-60), Marenus et al. fail to specifically disclose wherein a conductivity of the conductive spacer is greater than or substantially equal to a conductivity of a tissue of the treatment area and less than or equal to one hundred times (100x) the conductivity of the tissue of the treatment area. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Marenus et al. such that a conductivity of the conductive spacer is greater than or substantially equal to a conductivity of a tissue of the treatment area and less than or equal to one hundred times (100x) the conductivity of the tissue of the treatment area in order to provide the benefit of selecting a spacer that generates the desired cross-flow microcurrents over the skin surface to achieve the effect of preventing or treating skin damage as taught by Marenus et al. and 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.
Concerning claims 5-6, while Marenus et al. disclose examples of the conductive spacer (16) and the spacer (16) comprises a material or materials with sufficiently high electrical conductivity for generating the desired cross-flow microcurrent over the skin surface to achieve the effect of preventing or treating skin damage (Col. 2, ll. 43-52 & Col. 7, ll. 46-60), Marenus et al. fail to specifically disclose a height of the conductive spacer is based on a distance between the at least two electrodes, where the height of the conductive spacer is greater than or equal to twenty percent (20%) of a distance between the at least two electrodes and less than or equal to fifty percent (50%) of the distance between the at least two electrodes. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Marenus et al. such that a height of the conductive spacer is based on a distance between the at least two electrodes, where the height of the conductive spacer is greater than or equal to twenty percent (20%) of a distance between the at least two electrodes and less than or equal to fifty percent (50%) of the distance between the at least two electrodes in order to provide the benefit of selecting a spacer that generates the desired cross-flow microcurrents over the skin surface to achieve the effect of preventing or treating skin damage as taught by Marenus et al. and since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Concerning claim 11, while Marenus et al. disclose examples of the conductive spacer (16) and the spacer (16) comprises a material or materials with sufficiently high electrical conductivity for generating the desired cross-flow microcurrent over the skin surface to achieve the effect of preventing or treating skin damage (Col. 2, ll. 43-52 & Col. 7, ll. 46-60), Marenus et al. fail to specifically disclose a length of the conductive spacer is substantially equal to a length of one or more of the at least two electrodes. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Marenus et al. such that a length of the conductive spacer is substantially equal to a length of one or more of the at least two electrodes in order to provide the benefit of selecting a spacer that generates the desired cross-flow microcurrents over the skin surface to achieve the effect of preventing or treating skin damage as taught by Marenus et al. and since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
The Examiner notes that criticality is provided for a combination of the spacer’s conductivity, height, length, width and shape (recessed vs. non-recessed) as noted in Par. [203] of the originally filed disclosure.
Concerning claim 24, Marenus et al. disclose the at least two electrodes configured to delivery high voltage pulses have an amplitude of 1kV to 15kV when connected to an appropriate power source.
Concerning claim 25, Marenus et al. disclose the conductive spacer (16) is configured to be solid, compressible, or gelatinous (Col. 7-8, ll. 46-19).
Concerning claim 26, Marenus et al. disclose the electrode assembly (10) configured as a catheter, a percutaneous delivery device, a hand-held device, or a clamp (Col. 8, ll. 20-48).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marenus et al. (9,566,430, previously cited) in view of Balczewski et al. (2019/0282167, previously cited).
Concerning claim 16, as illustrated in at least Fig. 2 and discussed in Col. 4-5, ll. 56-25, Marenus et al. disclose an electrical therapy device (Fig. 2) comprising:
an electrode assembly for delivery of electrical therapy (topical or cosmetic system 10; [0034]), the electrode assembly comprising:
at least two electrodes (first element 12 acts as a cathode and second element 14 acts as an anode), configured to deliver high voltage pulses generated by a pulse generator (electrodes 104a, 104b are capable of being connected to an appropriate power source to deliver high voltage pulses), each of the at least two electrodes comprising:
a conductive treatment surface configured to apply electrical treatment to a treatment area (first and second elements 12, 14 have a surface that contacts skin surface 2), and
a conductive non-treatment surface configured to contact a conductive spacer (first and second elements 12, 14 have a surface that contacts third element 16 that electrically connects first and second elements 12, 14 together); and
the conductive spacer disposed between the at least two electrodes (third element 16 extends over a predetermined distance between elements 12, 14 and electrically connects first and second elements 12, 14 together) electrically contacting conductive non-treatment surfaces of the at least two electrodes (first and second elements 12, 14 have a surface that contacts third element 16 that electrically connects first and second elements 12, 14 together) and a surface of the treatment area of the subject between the at least two electrodes (surface of third element 16 contacts skin surface 2), wherein the conductive spacer is configured to direct electric current to extend the electrical treatment below the surface of the treatment area to improve uniformity and treatment depth (third element 16 is capable of this function when connected to an appropriate power source).
While Marenus et al. disclose an alternative embodiment comprising a treatment applicator (46A) ([0047], Fig. 5), Marenus et al. fail to disclose the electrode assembly to be a plurality of exchangeable electrode assemblies, and a treatment applicator configured to be coupled to the plurality of exchangeable electrode assemblies. However, Balczewski et al. disclose an electrical therapy device (300), comprising: a treatment applicator (302) configured to be coupled to the plurality of exchangeable electrode assemblies (304). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention such that the electrode assembly is a plurality of exchangeable electrode assemblies, and a treatment applicator configured to be coupled to the plurality of exchangeable electrode assemblies in order to provide the benefit of providing a device having a durable portion and a number of different disposable portions that can be used to provide configurations from which to select as taught by Balczewski et al. ([0095]; Fig. 3)
Allowable Subject Matter
Claims 17-23 & 27 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: the prior art, neither alone nor in combination, a method comprising applying high voltage pulses via an electrode assembly comprising a conductive spacer disposed between at least two electrodes, the electrodes and conductive spacer contacting the treatment area surface and made of “a material having consistency to maintain shape and position between the at least two electrodes”.
The closest prior art is regarded as: Kreis et al. (2019/0269904) teaches a method comprising applying high voltage pulses via an electrode assembly comprising at least two electrodes, but fails to disclose a conductive spacer. Chapman-Jones (2007/0239098, previously cited) teaches a conductive spacer between at least two electrodes, but teaches the spacer to be a tissue gel that is absorbed into the tissue and thus not made of “a material having consistency to maintain shape and position between the at least two electrodes” since it is absorbed by the tissue. Marenus (9,566,430) teaches a conductive spacer that creates a micro-current across a tissue treatment surface, but a POSITA would not have looked to Marenus to modify a method of applying high voltage pulses since Marenus teaches the conductive spacer to be used with micro-electrical currents.
Response to Arguments
Applicant’s arguments have been fully considered but they are not found persuasive.
In response to Applicant’s arguments regarding the 35 USC 112(b)/second paragraph rejection to claims 4 & 18 that the specification provides an example list of tissue types and even an example range of conductivity for epidermal tissue, the Examiner respectfully disagrees that the specification provides definiteness for the claim. First, the specification discusses the electrodes can be used on various tissues: “including heart, liver, or any other cell or tissue type to which treatment is to be applied“ ([0091]) or “skin, liver tissue, heart tissue, or any other type of tissue or cells” ([0118]). Thus, the specification fails to narrow the claim to a specific type of tissue. Second, the specification fails to disclose at what parameters, particularly frequency, the conductivity measurement is to be taken at to determine the tissue conductivity. Thus, a POSITA would not easily understand the type of tissue and how to determine the conductivity measurement in light of the specification. The rejection is maintained.
In response to applicant's argument that Marenus fails to teach the conductive spacer configured to direct electric current into tissue and instead teaches current across the skin surface, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case, when connected to a high voltage power supply and supplied with high energy voltage pulses is capable of the functional language.
The Examiner notes that the independent claims fail to specifically recite the high-voltage power supply for applying high voltage pulses to the electrodes creating an electric field between the electrodes that is affected by the conductive spacer.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAYMI E DELLA whose telephone number is (571)270-1429. The examiner can normally be reached on M-Th 6:00 am - 4:45 pm.
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794
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