DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) filed 3/16/2023 has been considered by the examiner.
Claim Objections
Claim 17 is objected to because of the following informalities:
Claim 17 line 3 should read: “a mask supplying a minimum moisture to a region…”
Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 16 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Suzuki et al. 5,817,138
Regarding claim 16, Suzuki teaches a method of applying microcurrent stimulation to a subject (abstract), the method comprising: applying a first electrode connected to a first polarity of microcurrent stimulation circuitry to a first side of the subject; applying a second electrode connected to a second polarity of the microcurrent stimulation circuitry to a second side of the subject (Column 3 line 41 states “The device provides about four or more channels for applying micro current to a patient, each channel having two electrodes for completing a micro current electrical circuit through patient tissue.” Figure 13 illustrates two separate electrodes connected to the positive and negative pole); providing microcurrent to the first electrode and the second electrode from the microcurrent stimulation circuitry (Column 3 line 46 states “a controller to provide controlled current in each channel from about 20 .mu.A to about 200 .mu.A at up to 300 Hz”); and applying a first probe to the subject to activate the first electrode and a second probe to the subject to activate the second electrode (Column 10 line 54 states “through the cotton Q tips of dual channel probes. Four Q Tips of two dual channel probes can be connected in parallel to the same output as 4 of the pads.”).
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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claims 1-9 and 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Suzuki et al. 5,817,138 in view of Baumann et al. 4,569,337
Regarding claim 1, Suzuki teaches a method of applying microcurrent stimulation to a subject (abstract), the method comprising: applying a first electrode connected to a first polarity of a microcurrent stimulation circuitry to a first side of the subject; applying a second electrode connected to a second polarity of the microcurrent stimulation circuitry to a second side of the subject (Column 3 line 41 states “The device provides about four or more channels for applying micro current to a patient, each channel having two electrodes for completing a micro current electrical circuit through patient tissue.” Figure 13 illustrates two separate electrodes connected to the positive and negative pole); and providing microcurrent to the first electrode and the second electrode from the microcurrent stimulation circuitry (Column 3 line 46 states “a controller to provide controlled current in each channel from about 20 .mu.A to about 200 .mu.A at up to 300 Hz”).
Suzuki fails to teach inserting feet of the subject into a liquid having a minimum conductivity of 5 mS/m; vibrating the liquid;
Baumann teaches an analogous stimulating device (Column 1 line 9) that does teach inserting feet of the subject into a liquid (Column 3 line 45 states ”the two longitudinal side parts 1, 2, the front side part 3 and the base 6 define a vessel which can be filled with water, whose bottom slopes upwards and away from the front side part 3 and consequently offers a comfortable foot support position for a person seated in front of part 3 and on which the heels can always be positioned lower then the toes, which helps to ensure a comfortable sitting position. When the user's feet have assumed this position“); vibrating the liquid ( Column 1 line 5 states “a support preferably provided with projections and serving as a massage surface and which is vibrated by means of a vibrator.”); It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Suzuki with the teachings of Baumann and include inserting feet of the subject into a liquid and vibrating the liquid as this provides the possibility of massaging fatigued and overstressed limbs to stimulate user circulation (Column 1 line 10).
Modified Suzuki fails to explicitly teach the liquid having a minimum conductivity of 5 mS/m, but does teach the use of water as the liquid. When the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. The standard conductivity of tap water is listed as in a range between 5-50 mS/m as stated by the specification of the present application, therefore the water used in Baumann would have a minimum conductivity of 5 mS/m.
Regarding claim 2, modified Suzuki teaches the method of claim 1, wherein the liquid extends above the feet of the subject (Column 3 line 45 of Baumann states “the front side part 3 and the base 6 define a vessel which can be filled with water, whose bottom slopes upwards and away from the front side part 3 and consequently offers a comfortable foot support position for a person seated in front of part 3 and on which the heels can always be positioned lower then the toes” based on the configuration of the vessel, the liquid would extend above the feet of the subject.).
Regarding claim 3, modified Suzuki teaches the method of claim 2, wherein the liquid covers ankles of the subject (Column 3 line 45 of Baumann states “the front side part 3 and the base 6 define a vessel which can be filled with water, whose bottom slopes upwards and away from the front side part 3 and consequently offers a comfortable foot support position for a person seated in front of part 3 and on which the heels can always be positioned lower then the toes.” Based on the configuration shown on figure 2, the water would have the ability to cover the ankles of the user due to the sloping portion.).
Regarding claim 4, modified Suzuki teaches the method of claim 1, further comprising: applying a third electrode connected to the first polarity of the microcurrent stimulation circuitry to the first side of the subject at an upper extremity of the subject (Figure 9a of Suzuki discloses electrode 3+ on the first side of an upper extremity of the subject connected to a positive polarity); and applying a fourth electrode connected to the second polarity of the microcurrent stimulation circuitry to the second side of the subject to the upper extremity of the subject (Figure 9a of Suzuki discloses electrode 3- on the second side of an upper extremity of the subject connected to a negative polarity).
Regarding claim 5, modified Suzuki teaches the method of claim 1, wherein the first side and the second side are a same side of the subject (Figure 8a of Suzuki teaches electrodes 8+ and 8- both on the same side of the subject but on opposite polarities).
Regarding claim 6, modified Suzuki teaches the method of claim 5, wherein the first electrode and the second electrode are both on an upper extremity of the subject (Figure 8a depicts 8+ and 8- on an upper extremity of the subject), and further comprising: applying a third electrode connected to the first polarity of the microcurrent stimulation circuitry to the first side of the subject at a lower extremity of the subject (Figure 8a depicts electrode 3+ on a first side of a lower extremity); and applying a fourth electrode connected to the second polarity of the microcurrent stimulation circuitry to the second side of the subject to the lower extremity of the subject (Figure 8a depicts electrode 3- on a second side of a lower extremity).
Regarding claim 7, modified Suzuki teaches the method of claim 5, wherein the first electrode and the second electrode are both on an upper extremity of the subject (Figure 9a depicts 5+ and 5- on an upper extremity of the subject), and further comprising: applying a third electrode connected to the first polarity of the microcurrent stimulation circuitry to the first side of the subject at the upper extremity of the subject (Figure 9a depicts 3+); and applying a fourth electrode connected to the second polarity of the microcurrent stimulation circuitry to the second side of the subject to the upper extremity of the subject (Figure 9a depicts 3-).
Regarding claim 8, modified Suzuki teaches the method of claim 1, wherein the first electrode and the second electrode are both on a lower extremity of the subject (Figure 8b depicts electrodes 2- and 2+).
Regarding claim 9, modified Suzuki teaches the method of claim 1, further comprising providing a sheet mask between the first electrode and/or the second electrode and the subject (Column 10 line 51 states “the electrical output is applied to the patient through 16 conductive pads attached to the area of interest”).
Regarding claim 11, modified Suzuki teaches the method of claim 1, wherein the microcurrent is 200 microamperes or less (The abstract of Suzuki states “The controller provides a controlled amount of current in each channel from about 20 micro amperes to about 200 micro amperes”).
Regarding claim 13, modified Suzuki teaches the method of claim 1, wherein the liquid is water (abstract of Baumann states “a wet massage when the vessel is filled with water,”).
Regarding claim 14, modified Suzuki teaches the method of claim 1, further comprising applying a first probe to the subject to activate the first electrode and a second probe to the subject to activate the second electrode (Column 10 line 54 states “through the cotton Q tips of dual channel probes. Four Q Tips of two dual channel probes can be connected in parallel to the same output as 4 of the pads.”).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over modified Suzuki in view of Brogan et al. 2010/0145413
Regarding claim 10, modified Suzuki teaches the method of claim 1, but fails to teach wherein vibrating the liquid includes vibrating the liquid at frequency between 1 and 100 Hz. Brogan discloses an analogous footbath with electrode stimulation (abstract) that does teach wherein vibrating the liquid includes vibrating the liquid at frequency between 1 and 100 Hz (0044 states “he pulses may be repeated at a selected frequency such as, for example, 50-100 Hz, 55-90 Hz or 60-80 Hz.”). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention modify modified Suzuki with the teachings of Brogan and include wherein vibrating the liquid includes vibrating the liquid at frequency between 1 and 100 Hz, as this is a commonly used frequency range for liquid vibrations.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over modified Suzuki in view of Sharma et al. 2018/0140835
Regarding claim 12, modified Suzuki teaches the method of claim 1, but fails to teach further comprising determining a duration for providing the microcurrent based on a body mass index of the subject. Sharma discloses an analogous therapeutic device that does teach determining a duration for providing the microcurrent based on a body mass index of the subject. Paragraph 0070 discusses the determination of current of an electrical stimulation based on tissue thickness aka BMI. It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify modified Suzuki with the teachings of Sharma and include a determination of current length based on BMI as this provides a tailored therapy to the individual based on their specific body composition.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over modified Suzuki in view of Yamazaki et al. 2005/0101994
Regarding claim 15, modified Suzuki teaches the method of claim 1, but fails to teach wherein the first electrode is applied to under a right side of a chin of the subject and the second electrode is applied to under a left side of the chin of the subject and further comprising providing a chin brace under the chin of the subject. Yamazaki discloses an analogous electrode stimulation device that does teach wherein the first electrode is applied to under a right side of a chin of the subject and the second electrode is applied to under a left side of the chin of the subject (Figure 1 depicts electrodes 3 located under both the left and right side of the chin) and further comprising providing a chin brace under the chin of the subject (V-shaped airbag 2). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify modified Suzuki in view of Yamazaki and include a chin brace for the purpose of securing electrodes to the chin of the user.
Claims 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Suzuki in view of Mohammadi et al. 2016/0089535
Regarding claim 17, Suzuki teaches a method of applying microcurrent stimulation to a subject (abstract), the method comprising: applying a first electrode connected to a first polarity of microcurrent stimulation circuitry to the mask; applying a second electrode connected to a second polarity of the microcurrent stimulation circuitry to the subject outside of the mask (Column 3 line 41 states “The device provides about four or more channels for applying micro current to a patient, each channel having two electrodes for completing a micro current electrical circuit through patient tissue.” Figure 13 illustrates two separate electrodes connected to the positive and negative pole); and providing microcurrent to the first electrode and the second electrode from the microcurrent stimulation circuitry (Column 3 line 46 states “a controller to provide controlled current in each channel from about 20 .mu.A to about 200 .mu.A at up to 300 Hz”). Suzuki fails to teach providing a mask supplying at a minimum moisture to a region to be treated.
Mohammadi teaches an analogous micro-current device that does teach providing a mask (Cosmetic delivery sheet 1) supplying at a minimum moisture to a region to be treated (the abstract states “The generator is activated by wetting to produce micro-current”, 0077 states “The adhesion of the sheet to the skin may occur via an adhesive compound associated with the surface of the sheet or it may be provided in the form of a gel or liquid, such as water, which moistens the sheet which then clings to skin”). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Suzuki with the teachings of Mohammadi and include providing a mask supplying at a minimum moisture to a region to be treated as the mask facilitates delivery of skin benefit agents (abstract).
Regarding claim 18, modified Suzuki teaches the method of claim 17, wherein the first electrode and the second electrode are on a same side of the subject (Figure 8a depicts electrodes 8+ and 8- on the same side of the subject).
Regarding claim 19, modified Suzuki teaches the method of claim 17, wherein the first electrode and the second electrode are centered on the subject (figure 10a depicts electrodes 2+ and 2- which are centered on the subject).
Regarding claim 20, modified Suzuki teaches the method of claim 17, wherein the mask includes nutrients to be absorbed by the subject (the abstract states “The micro-current generated facilitates delivery of skin benefit agents from the sheet by iontophoresis, or directly affects treatment by delivery of iontophoresis micro-current to the skin.”).
Conclusion
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/ROHAN PATEL/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785