DETAILED ACTION
This action is responsive to the RCE filed 10/10/25.
Claims 1, 4-9 and 11-18 are rejected.
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.
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 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 4-9 and 11-18 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 and 11 recites the limitation "the edge portion". There is insufficient antecedent basis for this limitation in the claim.
Claims 5 and 13 recites the limitation "said isolating cover layer" and “the isolating cover layer”. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 1, 4-8, 12-15 and 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zemel et al. (WO 2013/040542, “Zemel”) in view of Kalghatgi et al. (US 20150157870, “Kalghatgi”).
Regarding claim 1, Zemel teaches a flexible (Pg. 6, line 4, ‘In some implementations, the electrode can be flexible’) electrode (Fig. 6 and pg. 24, par. 1, ‘a treatment electrode including a conductor 1 surrounded at least in part by an insulating material 2’) arrangement for wound treatment of a surface to be treated of an electrically conducting body (According to MPEP 2111.02(I), ‘If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.’; therefore the fact that the preamble merely states an intended use of the device rather than a distinct definition of the claimed invention’s limitations renders it of no significance to claim construction), the surface to be treated being used as a counter electrode for generating a dielectric barrier discharge plasma (Pg. 7 and par. 1, ‘Simultaneously, some plasma will usually form around the periphery of the curved dielectric layer(s) in use and conduct to the surface of the nail plate.’), the flexible electrode arrangement comprising: a multi-layered stack comprising distinct layer structures (Fig. 6) including: a first electrode (figure 6 and page 24, lines 1-2, ‘treatment electrode including a conductor 1 surrounded at least in part by an insulating material 2’); a spacer/dielectric layer (figure 6 and page 24, line 30 – page 25, line 15, ‘The surface of insulating material 2 that faces and/ or contacts a user's/patient's tissue (e.g., nail) can be provided with one or more bumps, ridges or undulations 78 that are distinct and on a generally larger scale than the surface finish […] The material of the dielectric can also be provided with pores. These pores can serve as microcavities for a plasma microdischarge. These pores may be connected to one another or be separate and distinct. Such pores could be regular, as in a capillary array, or irregular in distribution. The shape of the pores may be spherical, cylindrical, or other.’); and wherein in a non-flexed orientation of the multi-layered stack of distinct layer structures (Fig. 6, dielectric layer 2 and electrode layer 1): each distinct layer structure has respective parallel first planar and second planar surfaces (Fig. 6, parallel surfaces of dielectric layer 2 and electrode layer 1 respectively), each distinct layer structure occupies a respective distinct parallel plane of a plurality of distinct parallel planes (Fig. 6, below, dielectric layer 2 and electrode layer 1 occupy distinct parallel planes), the first electrode occupies a first plane of the plurality of distinct parallel planes (See annotated fig. 6, below, plane of electrode layer 1), the spacer layer occupies a second plane of the plurality of distinct parallel planes, separate from the first plane (See annotated fig. 6, below, plane of dielectric layer 2), and comprises a plurality of openings through the spacer layer (Pg. 25, lines 8-15, ‘The material of the dielectric can also be provided with pores. These pores can serve as microcavities for a plasma microdischarge. These pores may be connected to one another or be separate and distinct. Such pores could be regular, as in a capillary array, or irregular in distribution. The shape of the pores may be spherical, cylindrical, or other.’), each opening of the plurality of openings extending from a top surface of the spacer layer to a bottom surface of the spacer layer (Fig. 6, showing the pores extending from the top surface of the spacer/dielectric layer adjacent to electrode 1 to the nail surface), each opening defined within the second plane being completely bounded by the spacer layer material such that a first opening of the spacer layer is isolated from a second opening, adjacent to the first opening, by a portion of the spacer layer without interconnection (Pg. 25, lines 9-10, “These pores may be connected to one another or be separate and distinct.”); and wherein in a flexed orientation of the multi-layered stack of distinct layer structures the first electrode is constructed to be reshaped to a flexed orientation to conform to the surface to be treated (Pg. 20, lines 22-23, “This flexible or semi-flexible treatment electrode, 1, can be bent to conform to the shape of the target nail structure (not shown).”); and an edge section extending laterally from the plurality of openings (See annotated fig. 6, below, the edge section can be considered the portion of the of the structured surface which extends around the periphery of the device surrounding the various pores and which has lateral dimension and which therefore ‘extends laterally’),and wherein the edge section confines the plurality of openings (See annotated fig. 6, below, the edge can be considered the portion of the of the structured surface which extends around the periphery of the device and which surrounds the various pores) such that the edge section together with the bounded openings confines plasma and acts as a barrier to prevent, in use, an airflow of gas from flowing radially wider than the electrode (Pg. 26, line 27 – pg. 27, line 1, ‘The spacer/spacing means can be provided around the periphery of the treatment electrode, in which case it can also surround or encapsulate the local gas. By surrounding the local gas, the structure can facilitate concentration of the heat and reactive species in the desired treatment area.’).
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Annotated Figure 6 of Zemel
In the device of Zemel, the dielectric layer and spacer layer are provided as a single material, therefore, Zemel fails to teach that the dielectric layer occupies a third plane of the plurality of distinct parallel planes, and is formed by a coating or foil of a flexible material that is distinct from the spacer layer, and shields the first electrode from the surface to be treated; that the edge section occupies the third plane and that while in a non-flexed orientation at least a portion of the edge section has a width or diameter larger than a width or diameter of the coating or foil of the dielectric layer such that the edge section confines the plurality of openings to a position below the coating or foil of the flexible material preventing, in use, an airflow of gas from flowing radially wider than the coating or foil of the flexible material.
With respect, to the distinctness between the dielectric layer and spacer layer aspect, Kalghatgi teaches an electrode arrangement (Fig. 8, DBD jet pad 700 having flexible electrode 710) for wound treatment of a surface to be treated of an electrically conducting body (Par. 2, ‘conforming DBD plasma generators for use in skin and wound treatment applications’), the surface to be treated being used as a counter electrode for generating a dielectric barrier discharge plasma (Par. 21, ‘In some embodiments, ground conductors are not used. In such an embodiment, the object to be treated with plasma is grounded, and the object serves as the ground conductor 108.’), the flexible electrode arrangement comprising: a multi-layered stack comprising distinct layer structures (Fig. 8) including: a first electrode (Fig. 8, flexible electrode 710); a spacer layer (Fig. 8, spacers 706); and a dielectric layer (Fig. 8, dielectric barrier 712), wherein in a non-flexed orientation of the multi-layered stack of distinct layer structures (Fig. 8): each distinct layer structure has respective parallel first planar and second planar surfaces (Fig. 8, respective first and second parallel planar surfaces of electrode 710, spacer 706 and dielectric barrier 712), each distinct layer structure occupies a respective distinct parallel plane of a plurality of distinct parallel planes (See annotated fig. 8 below showing electrode 710, dielectric barrier 712 and spacer 706 occupying distinct parallel planes), the first electrode occupies a first plane of the plurality of distinct parallel planes (See annotated fig. 8 below), the spacer layer occupies a second plane of the plurality of distinct parallel planes, separate from the first plane (See annotated fig. 8 below), and comprises a plurality of openings through the spacer layer (Fig. 8, plurality of treatment cavities 824), each opening of the plurality of openings extending from a top surface of the spacer layer to a bottom surface of the spacer layer (Fig. 8, cavities 824 extend from the top surface of spacer 706 to the bottom surface of spacer 706); and the dielectric layer occupies a third plane of the plurality of distinct parallel planes (See Annotated fig. 8, below), is formed by a coating or foil of a flexible material (Par. 4, ‘flexible dielectric barrier’) that is distinct from the spacer layer (Fig. 8 showing that dielectric 712 is separate from spacer 706), and shields the first electrode from the surface to be treated (Fig. 8 showing dielectric barrier 712 between electrode 710 and skin 730); and wherein in a flexed orientation of the multi-layered stack of distinct layer structures the first electrode is constructed to be reshaped to a flexed orientation to conform to the surface to be treated (Par. 2, ‘shape conforming DBD plasma generators’); and an edge section extending laterally from the plurality of openings (Fig. 8, the edge portion can be considered the peripheral portion of the pad 700 that extends around cavities 824) and that occupies the third plane while in a non-flexed orientation (See annotated fig. 8, below; the edge section extends through each of the first, second and third planes), at least a portion of the edge section having a width or diameter larger than a width or diameter of the coating or foil of the dielectric layer (See annotated fig. 8, below, the edge section surrounds the dielectric barrier and therefore has a larger diameter than the dielectric barrier; alternatively, the edge section extends through the first, second and third planes and therefore, has a larger width than the dielectric barrier) and wherein the edge section confines the plurality of openings to a position below the coating or foil of the flexible material (See annotated fig. 8, below, showing the edge section confining the cavities/openings to a position below the dielectric layer) such that the edge section together with the bounded openings confines plasma and acts as a barrier to prevent, in use, an airflow of gas from flowing radially wider than the coating or foil of the flexible material (Fig. 8, considering that spacer 706 and the edges section along the periphery of the device is intended to be placed in abutment to skin 730, is the examiner’s position that the edge section along with cavities 824 could be used to prevent gas from flowing radially wider than the extent of the dielectric barrier 712).
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Annotated Fig. 8 of Kalghatgi 1
Therefore, since both Zemel and Kalghatgi teach different implementations for dielectric barrier layers for use in cold plasma devices—the configuration of Zemel in which the dielectric layer is incorporated into the spacer layer, the configuration of Kalghatgi in which the dielectric is provided as a layer separate from the spacer layer and which is sandwiched between the electrode and the spacer layer—it would have been obvious to POSITA at the time that the invention was filed to substitute one known dielectric barrier layer configuration for the other in order to arrive at the predictable result of a dielectric barrier layer for use in a cold plasma treatment device. KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007).
Further, since Zemel is now being modified to provide separate distinct layers for the spacer layer and dielectric layer, it follows that the electrode, spacer layer and dielectric layer would respectively occupy distinct first, second and third planes, as clearly shown by Kalghatgi (See Annotated fig. 8, above).
Further, since the edge sections of both Zemel and Kalghatgi are used to encapsulate the gas preventing escape from the pores (Pg. 26, line 27 – pg. 27, line 1), which are located directly under the electrodes, and since Zemel is being modified in view of Kalghatgi to comprise a dielectric barrier which completely covers the electrode which is sandwiched between the spacer layer and the electrode, it follows that in the modified device the edge section would facilitate the retention of the gas within the pores of the spacer and therefore prevent gas from flowing radially to an extent wider than the dielectric layer.
Finally, it should be noted that the dielectric layer of Kalghatgi is located within the boundaries of the edge section of the device and therefore, upon modification, the edge section of Zemel, would similarly encompass the dielectric layer in the sense of having a wider diameter than the dielectric layer and also would extend vertically through the third plane, as illustrated by annotated fig. 8 of Kalghatgi.
Regarding claim 4, Zemel, as modified, fails to teach wherein the edge portion is non-stretchable.
The examiner maintains, however, that it would have been obvious to one of ordinary skill in the art at the time that the invention was filed to construct the edge portion of the spacer of a non-elastic material, 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.
Regarding claim 5, Zemel, as modified, further teaches wherein a second electrode covers said isolating cover layer (Pg. 8, lines 28-29, ‘The ground pad can be embedded into the electrode, or can be formed about a periphery of the electrode’).
Regarding claim 6, Zemel, as modified, further teaches wherein the second electrode electrically connects to a conductive ring electrode (Pg. 8, lines 28-29, ‘The ground pad can be embedded into the electrode, or can be formed about a periphery of the electrode’).
Regarding claim 7, Zemel, as modified, further teaches wherein the conductive ring electrode comprises a conductive sticker edge (Pg. 35, lines 10-11, ‘This grounding conductor is optionally mounted to the tissue via a conductive tissue adhesive or gel.’).
Regarding claim 8, Zemel, as modified, further teaches wherein the first electrode is a stretchable mesh (Pg. 6, lines 4 and 16-22, ‘The flexible electrode can include a layer of conductive material […] The layer of conductive material can be a continuous layer or an interrupted layer. The interrupted layer can be etched and/or a mesh’).
Regarding claim 12, Zemel, as modified, further teaches wherein the electrode arrangement is substantially transparent, so that in operation an underlying body undergoing treatment and the created plasma can be visually observed (Pg. 37, lines 10-12, ‘The mesh was connected to ground and used as a transparent electrode to enable visualization of plasma formation within the gap.’).
Regarding claim 13, Zemel, as modified, teaches that the isolating cover layer is transparent (Pg. 9, lines 14-15, ‘The layer of conductive material may be, transparent, and may include indium tin oxide (ITO), as desired’) and flexible (page 24, line 10, ‘If desired, the insulating material can be rigid or flexible’), but fails to teach that the cover layer and the spacer layer are provided from a single preform.
The examiner maintains, however, that it would have been obvious to one of ordinary skill in the art at the time that the invention was made to make the cover layer and spacer of a single preform as claimed, since it has been held to be a matter of obvious design choice to make a one-piece construction out of a structure previously disclosed by the prior art. In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965).
Regarding claim 14, Zemel, as modified, further teaches wherein the first electrode is a planar structure (Fig. 5, conductor 1), and wherein the planar electrode structure is connected to a contact with a slide contact of a PCB (Pg. 35, lines 16-23, ‘The plasma emitter can be connected to the power supply by a variety of techniques. For example, short wires having an external connector may be laminated, glued, soldered, or crimped onto the conductive layer of the flexible plasma emitter. Alternatively, a variety of connectors may be mounted (via soldering, lamination, or gluing) on the conductor of the plasma emitter. These can include, for example, snap connectors, surface mount connectors, pin holes, crimp or clamps connectors, among others.’; e.g. ‘surface mount connectors’).
Regarding claim 15, Zemel, as modified, further teaches a driver circuit for driving the first electrode coupled to the high voltage source (Pg. 16, lines 2-5, ‘The controller can be adapted and configured to adjust the applied voltage in response to a signal received from the conducting pad to maintain a controlled and substantially uniform power deposition in the anatomical region of interest.’), wherein the driver circuit drives the first electrode in a pulsed voltage in a range of 3kV-8kV (Pg. 26, lines 20-21, ‘Such voltages range, for example, from about 500 to about 1000 volts, about 1000 -about 10000 volts, and about 10000 - about 50000 volts’), with a repetition rate in a range of .5kHz-50kHz (Pg. 5, lines 10-11, ‘Frequency of such pulses may also be varied from only a few Hertz to several thousand Hertz.’), and with a pulse duration in a range of 0.1 microseconds-100 microseconds (Pg. 5, lines 9-10, ‘duration can be varied from about 1 ns to 1000 ns,’; e.g. 1000 ns is equivalent to 1 microsecond).
Regarding claim 17, Zemel, as modified, further teaches wherein a gas control structure is provided in the electrode arrangement, and wherein the gas control structure is arranged to generate plasma precursor (Pgs. 28, line 21-30).
Regarding claim 18, Zemel, as modified, further teaches wherein the gas control structure comprises a gas drain or a gas absorbent (Pg. 27, line 1-3, ‘Such a border can also incorporate an ozone-absorbing material, such as carbon black, to absorb the ozone that is commonly generated by the dielectric barrier discharge.’).
Claim 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zemel in view of Kalghatgi, as applied to claims 1, 4-8, 12-15 and 17-18, above, and further in view of Weltmann et al. (US 20150088234, “Weltmann”).
Regarding claim 9, Zemel, as modified, teaches that the first electrode can be a mesh, but fails to teach wherein the first electrode is formed from a continuous conductive wire.
Weltmann teaches an analogous device for providing therapeutic non-thermal plasma (Abstract), in which the active electrode is formed from a continuous conductive wire (Figs. 1-2, high-voltage electrode of insulated wire 2).
Since both Zemel, as modified, and Weltmann teach analogous high voltage electrode configurations for producing therapeutic non-thermal plasma, it would have been obvious to POSITA at the time that the invention was filed to substitute one known electrode configuration for the other in order achieve the predictable result of a high voltage electrode for producing non-thermal plasma. KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007).
Claim 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zemel in view of Kalghatgi, as applied to claims 1, 4-8, 12-15 and 17-18, above, and further in view of Hancock (US 20130267943).
Regarding claim 11, Zemel, as modified, teaches that the plasma emitter can be connected to the power supply through wires having external connectors (Pg. 35, lines 17-18), but fails to teach that the wiring which connects the external connectors to the plasma emitter is a twisted pair lead.
However, in the same field of endeavor Hancock teaches the use of a twisted pair for the transfer of high frequency energy (Par. 34).
In view of Hancock, it would have been obvious to POSITA at the time that the invention was filed to further modify Zemel, as modified, by utilizing twisted pair wirings to connect the ground/active electrodes to external connectors, as taught by Hancock, in order to reduce the effect of noise currents induced on the line by coupling of electric or magnetic fields.
Claim 16 is/are rejected under 35 U.S.C. 103 as being unpatentable Zemel in view of Kalghatgi, as applied to claims 1, 4-8, 12-15 and 17-18, above, and further in view of Baker et al. (US 6149620, “Baker”).
Regarding claim 16, Zemel, as modified, teaches a driver circuit, but fails to teach that the driver circuit comprises a planar electrode identification circuit.
Baker teaches an analogous device for producing plasma (Abstract and par. 19, ‘In some embodiments a conductive fluid is delivered into the intervertebral disc prior to applying the high frequency voltage to ensure that sufficient conductive fluid exists for plasma formation and to conduct electric current between the active and return electrodes’), in which a driver circuit comprises an electrode identification circuit (Par. 155, ‘According to the present invention, the probe 20 further includes an identification element that is characteristic of the particular electrode assembly so that the same power supply 28 can be used for different electrosurgical operations.’).
In view of Baker, it would have been obvious to POSITA at the time that the invention was filed to further modify Zemel, as modified, by providing the controller with an identification circuit, as taught by Baker, in order to configure the controller to be automatically compatible with a variety of plasma electrodes having different operating parameters, as taught by Baker.
Response to Arguments
Applicant's arguments filed 10/10/25 have been fully considered but they are not persuasive. The examiner disagrees that applicant’s clarifying amendment obviates the previous rejection which was affirmed by the patent board decision dated 8/12/25. Applicant argues that the fact that the amendment clarifies that the claimed ‘openings’ are isolated from each overcomes Zemel, as modified. The examiner disagrees and maintains that this argument is based on a misconstrual of the patent board decision. For instance, pg. 9 of the decision states:
In any event, the Examiner has shown that Zemel's compartments (pores) are isolated because they are located in between the different protrusions and Zemel describes these "pores" as being separate and distinct from each other. Final Act. 4 (citing Zemel Fig. 6, holes 3, page 23, lines 9-10). We agree with the Examiner's finding and deem Appellant's arguments to the contrary (relying on Kalghatgi for the most part) unpersuasive of reversible error.
Therefore, it is clear that the patent board agreed with the examiner assessment that Zemel natively teaches pores which are isolated from each other and that applicant’s clarifying amendment is not enough to overcome the rejection.
Further, the examiner disagrees with applicant’s contention that Kalghatgi teaches a dielectric layer which is merged with the spacer layer. Clearly fig. 8 of Kalghatgi shows that dielectric barrier 712 is separate and distinct from both electrode 710 and spacer 706. Further, this interpretation was affirmed by the patent board. For instance, pg. 8 of the board decision states:
The rejection relies on Kalghatgi as evidence that it is known to use
separate layers for the dielectric and conductor. Ans. 10; Final Act. 8. The
arrangement of the spacer layer, isolating layer, and the contact with the skin
is taught by Zemel according to the Examiner, and we agree. Final
Act. 3-5. Accordingly, arguing that the plasma generation in Kalghatgi
results in non-isolated cavities is not responsive because it is Zemel's device
that the Examiner relies on for the dielectric barrier discharge plasma
generated to treat the nail fungus, with the structures as described in Zemel,
modified by the evidence that a dielectric layer can be configured as a
distinct layer. Final Act. 8-9; Ans. 10-11.
Therefore, the rejection is maintained.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM JOSEPH AVIGAN whose telephone number is (571)270-3953. The examiner can normally be reached Monday-Friday 9am-5pm.
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ADAM JOSEPH. AVIGAN
Examiner
Art Unit 3739
/ADAM J AVIGAN/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
Prosecution Insights