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 .
Response to Amendment
The amendment to the claims filed on January 7, 2025 does not comply with the requirements of 37 CFR 1.121(c). Specifically, the claim listing does not commence on a separate sheet of the amendment document, and the sheet that contains the claim text contains extra verbiage regarding the instructions for making the claim amendments. See MPEP 714 and 37 C.F.R. 1.121(c). In the interest of compact prosecution, the amendments have been entered. Applicant is hereby notified that any future amendments that do not comply with 37 C.F.R. § 1.121 may not be entered.
Specification
The disclosure is objected to because of the following informalities: Para. [0092]; Between the second and third sentences there are two periods and an extra space; “that cause discomfort. . In.” Additionally, in para. [0150], the applicant recites “dispersion the in base polymer” (most likely meant “dispersion in the base polymer”).
Appropriate correction is required.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “102” has been used to designate both “counter electrode” and “working electrode” (para. [0091]; Fig. 1C) Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: para. [0091]; the neurostimulation device 100 is not labeled in Fig. 1C. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “antistatic material configured to bloom” in claim 1. The Examiner notes that the use of the term “antistatic material” acts as “a generic placeholder for the term ‘means’ and would not be recognized by one of ordinary skill in the art as being sufficiently definite structure for performing the claimed function” (MPEP 2181, I). The description of the material as being generally “antistatic” (i.e. any material capable of preventing the buildup of static electricity; the adjective “antistatic” describes the functionality of the material) is inadequate to describe a specific material configured to bloom. In the applicant’s case, “material” is a generic placeholder and is modified by the term “antistatic,” meaning a material that functions to prevent the buildup of static electricity. Further functional language follows the placeholder (“material”) as the claim recites that it is “configured to bloom…”. The means (or in this case generic placeholder) modified by the functional language and a lack of specific structure that performs that function, is sufficient to meet the 3-prong analysis and invoke 112(f).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The applicant recites the limitation “the skin contact layer comprising an antistatic material configured to bloom to a skin facing surface of the skin contact layer to form a layer of conductive lubricant when the skin contact layer is in contact with a heat source.” The Examiner notes that the specification only repeats the functional language/result of “the antistatic material configured to bloom to a skin facing surface of the skin contact layer” without setting forth any particular details regarding how the antistatic material is configured to bloom or the composition of the antistatic material that gives it the blooming capabilities. For instance, in para. [0009], [0015], [0016], [0019], and [0168 – 0171], the antistatic material is described by the functional language (“configured to bloom”). However, a written description of the antistatic material’s configuration is not given as to the specific structures that make it bloom.
In para. [0009], the antistatic material is described as “incompatible with silicone electrodes which advantageously causes the antistatic material to bloom,” but no description correlates the blooming process with the incompatibility. Further, it also states that “warm skin causes the antistatic material to bloom naturally to the surface,” without describing the correlation between heat and blooming.
Additionally, in para. [0167], the applicant recites “may include migratory additives that are incompatible with silicone.” However, the recitation of “migratory additives” is a generic term that inadequately describes the blooming process.
Lastly, para. [0167] recites that the antistatic material “may be for example, RD Abbott's antistatic material…or a coconut oil derivative.” However, the written description is still inadequate in describing the correlation between the antistatic material’s configuration to perform the blooming process.
Although the written description of the generic antistatic material is present regarding some aspects, the specification is silent regarding the correlation between the antistatic material’s configuration and the resulting blooming process.
For instance, in Additive blooming in polymer materials: Consequences in the pharmaceutical and medical field, Nouman et al. mention the implementation of various additives into different materials that may cause blooming. However, there is a wide-range of possible blooming agents can be used, and controlling these parameters results in different effects regarding blooming and material properties as made clear by Nouman et al. In the abstract, Nouman et al. states, “We report the parameters that influence the occurrence of blooming such as temperature, polymer morphology, additive shape and size). In short, a variety of additives can be incorporated to provide a material with antistatic properties, but there are many parameters that must be controlled for blooming to occur. The applicant lacks a written description to convey the correlation between the antistatic material’s configuration and blooming process.
Claims 2-8 are also rejected for the same reason due to their dependency on claim 1.
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, 12, 13, and 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 4, the claim recites wherein the skin contact layer is incompatible with silicone. The use of the term “incompatible” is indefinite because it is not defined what could be considered incompatible. There are many ways in which materials can be incompatible, and no definition is provided for incompatible. For examination purpose, the claim will be considered with broadest reasonable interpretation. For examination purposes, the claim will be interpreted as any material that is not compatible, meaning there is a reaction between the materials.
Regarding claim 12, the applicant recites “adequate electrical conductivity” but does not define what constitutes as “adequate.” Further, the applicant recites “placed on to comfortably deliver transcutaneous electrical stimulation.” The use of the term “comfortably” is subjective to the user and is not defined. For examination purpose, Examiner will assume adequate means any degree of electrical conductivity sufficient for transcutaneous electrical stimulation.
Further regarding claim 12, the claim recites “a skin location where the self-wetting electrode is placed on.” However, the applicant claims both a product (“the self-wetting electrode”) and a method of using the product (“placed on”). It is unclear if the applicant is claiming the method of using the self-wetting electrode or the self-wetting electrode product.
Regarding claim 13, the claim recites “an amount of the antistatic material is sufficient to cover substantially all of the skin facing surface” of the skin contact layer.” The use of “sufficient to cover substantially all” is vague and indefinite. It does not define the amount of antistatic material necessary, or the amount of coverage that the antistatic material is applied. For examination purpose, Examiner will assume the amount of antistatic material covers an amount of the surface sufficient enough to conduct electricity for transcutaneous electrical stimulation.
Regarding claim 14, the claim recites “wherein an amount of antistatic material is configured to not impact properties of the skin contact layer.” The recitation of the term “not impact” is indefinite because it is unclear the amount of antistatic material is enough to impact the properties of the skin contact layer. Additionally, it is unclear how the antistatic material is configured to not impact the skin contact layer, and inadequate detail is provided in the specification. Further, the skin contact layer of claim 9 is recited as “comprising an antistatic material”; however, no further details regarding the structure of the skin contact layer are given. Therefore, it cannot be determined how the antistatic material is configured to not impact the skin contact layer if the skin contact layer is the only the antistatic material. For examination purposes, Examiner will interpret this as an amount of antistatic material that does not change the contact layer’s structure.
Regarding claim 22, the claim recites “wherein the skin contact layer has a Shore hardness between about 35 A to about 65 A.” The use of the term “about” is vague and indefinite. In the context of Shore hardness, the range of values that can be considered “about 35A” to “about 65A” is unclear. There is no objective way to assess for infringement with the recited claim language, and thus, the metes and bounds are not clearly established. For example, one of ordinary skill in the art would not know if 30A is about 35A, or if 70A is about 65A, or other values that could be considered “about.” For examination purposes, the claim will be interpreted as a Shore hardness near the range 35A to 65A or with an overlap within the range.
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.
(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(s) 9-17 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pastoor et al. (US 20180116546 A1, herein after referred to as “Pastoor”).
Regarding claim 9, Pastoor doesn’t specifically teach a “self-wetting electrode,” but instead a dry electrode comprising of self-wetting material. According to the preamble of claim 9, a self-wetting electrode comprises a conductive backing layer, a skin contact layer, and an antistatic material on the surface of the skin contact layer. Since Pastoor discloses the limitations in the body of claim 9, it is understood that the dry electrode of Pastoor meets the broadest reasonable interpretation of a self-wetting electrode as defined by the particulars in the body of the claim. Pastoor also discloses wherein the electrode is used for transcutaneous electrical stimulation.
Pastoor discloses a self-wetting electrode (Fig. 1; para. [0026]; “an electrode body”; para. [0033]; “the dry silicone electrode”) for transcutaneous electrical stimulation (para. [0043; used for transcutaneous nerve stimulation”;) comprising: a conductive backing layer (Fig. 1; the layer between 110 and 102; para. [0044]; “Electrical coupling 110 is electrically coupled to electrode body 102 such that it enables electrical signals to be received and/or transmitted from and/or to skin 104; In some embodiments, additional components and/or layers of material are disposed between electrical coupling 110 and/or electrode body 102”); and a skin contact layer (Fig. 1; the layer of the electrode body 102 between the skin 104 and the electrode body 102) disposed on the conductive backing layer (Fig. 1; the layer between 110 and 102; para. [0044]; “Electrical coupling 110 is electrically coupled to electrode body 102 such that it enables electrical signals to be received and/or transmitted from and/or to skin 104; In some embodiments, additional components and/or layers of material are disposed between electrical coupling 110 and/or electrode body 102”), the skin contact layer configured to deliver electrical current from the conductive backing layer to the skin for transcutaneous electrical stimulation (Fig. 1; the layer between the skin 104 and the electrode body 102; para. [0044]; "enables electrical signals to be received and/or transmitted from and/or to skin 104"), the skin contact layer comprising an antistatic material (para. [0027]; the detergent in the electrode body 102 is antistatic; "electrode body 102 includes silicone material, electrical conductive particles, and detergent; para. [0032]; “The interaction of water with the ions (added by the detergent) is configured to function as a salt-bridge”) configured to form a layer of conductive lubricant (para. [0032]; "the detergent is configured to absorb more than 20% by weight of water. The interaction of water with the ions (added by the detergent) is configured to function as a salt-bridge"; the salt-bridge formed is a layer between the skin 106 and the electrode body 102) when the skin contact is in contact with a heat source (Fig. 1; electrode body 102 is shown in contact with the skin 104, which is a part of the body 106 (which is a source of heat)).
Regarding claim 10, Pastoor discloses the self-wetting electrode from claim 9 (see rejection above), wherein the layer of conductive lubricant is non-sticky and moisturizing (para. [0031]; "the soap or detergent may include alpha-olefin sulfonate"; para. [0026]; “Electrode 100 is soft and skin friendly due to the hydrophilic silicone material having moisture regulating properties”; Alternatively, para. [0056]; "The electrode body includes a conductive silicone material configured to enable uptake or diffusion of moisture from the skin of the subject over which the electrode body is disposed"; The uptake and then diffusion of moisture from the skin would be non-sticky and moisturizing since sweat can act as both a non-sticky and moisturizing lubricant.)
Regarding claim 11, Pastoor discloses the self-wetting electrode of claim 9 (see rejection above), wherein the layer of conductive lubricant (para. [0032]; "the detergent is configured to absorb more than 20% by weight of water. The interaction of water with the ions (added by the detergent) is configured to function as a salt-bridge"; the salt-bridge formed is a layer between the skin 106 and the electrode body 102) is configured to provide a higher electrical conductivity ([0011]; “a detergent configured to facilitate a flow of ions through the conductive silicone material”) between the skin contact layer and a skin (para. [0012]; “conductive silicone material; receiving and/or transmitting electrical signals from and/or to the skin of the subject via the conductive silicone material of the electrode body”) location where the self-wetting electrode is placed on as compared to the electrical conductivity between the skin contact layer and the skin location without the layer of conductive lubricant. Although Pastoor does not specifically disclose a higher conductivity with the detergent compared to without the detergent, Pastoor does disclose that his device is an improvement from dry electrodes without the detergent (para. [0010]; “an improved dry electrode with a low impedance skin interface”). Pastoor makes clear that the addition of the detergent improves the flow of ions, and thus conductivity (para. [0026]; “a detergent configured to facilitate a flow of ions through the conductive silicone material.”)
Regarding claim 12, due to the indefiniteness of the recited terms “adequate electrical conductivity” and “placed on to comfortably deliver transcuataneous electrical stimulation,” it is unclear as to what can be considered “adequate electrical conductivity” and “comfortably” delivered stimulation. The claim is interpreted as an electrode with a lubricant that is conductive enough to transmit electrical stimulation to the skin.
Pastoor discloses the self-wetting electrode from claim 9 (see rejection above), wherein the layer of conductive lubricant (para. [0032]; "the detergent is configured to absorb more than 20% by weight of water. The interaction of water with the ions (added by the detergent) is configured to function as a salt-bridge"; the salt-bridge formed is a layer between the skin 106 and the electrode body 102) is configured to provide adequate stimulation between the skin contact layer (Fig. 1; the layer of the electrode body 102 between the skin 104 and the electrode body 102) and a skin location (Fig. 1; the skin 106 where electrode body 102 is placed) where the self-wetting electrode is placed on to comfortably deliver transcutaneous electrical stimulation (para. [0008]; “Another application is electrical stimulation of the skin”).
Regarding claim 13, due to the indefiniteness of the recited terms “an amount of the antistatic material is sufficient to cover substantially all,” it is unclear what amount of antistatic material is necessary. Thus, the claim will be considered with the broadest reasonable interpretation.
Pastoor discloses the self-wetting electrode from claim 9 (see rejection above), wherein the amount of antistatic material (para. [0027]; the detergent in the electrode body 102; "electrode body 102 includes silicone material, electrical conductive particles, and detergent") is sufficient to cover substantially all of the skin facing surface of the skin contact layer (para. [0031]; "In some embodiments, the soap or detergent are mixed with the conductive silicone material to form a homogeneous material”; The mixing of the detergent in the silicone and homogeneous dispersion covers the skin facing surface and exposes the skin to the detergent).
Regarding claim 14, due to the indefiniteness of the recited terms “the amount of antistatic material is configured not to impact properties of the skin contact layer,” it is unclear what is considered “not to impact” the skin contact layer. Thus, the claims are given the broadest reasonable interpretation. For examination purposes, Examiner will interpret this as an amount of antistatic material that does not change the contact layer’s structure.
Pastoor discloses the self-wetting electrode from claim 9 (see rejection above), wherein the amount of antistatic material (para. [0027]; the detergent in the electrode body 102; "electrode body 102 includes silicone material, electrical conductive particles, and detergent") is configured to not impact the properties of the skin contact layer (para. [0031]; "In some embodiments, the soap or detergent are mixed with the conductive silicone material to form a homogeneous material"; This ability to mix the silicone skin contact layer and the detergent demonstrates that the skin contact layer of the electrode body 102 is not impacted by the detergent).
Regarding claim 16, Pastoor discloses the self-wetting electrode of claim 9 (see rejection above), wherein the conductive backing layer (Fig. 1; the layer between 110 and 102; para. [0044]; “Electrical coupling 110 is electrically coupled to electrode body 102 such that it enables electrical signals to be received and/or transmitted from and/or to skin 104; In some embodiments, additional components and/or layers of material are disposed between electrical coupling 110 and/or electrode body 102”; para. [0044]; " a portion of electrical coupling 110 may be made of a metallic material"). It should be noted that the metallic portion of electrical coupling meets the broadest reasonable interpretation of a metallic foil since it is a thin layer of metal. Further, Pastoor discloses that there may be additional conductive layers and that a portion is metallic. This layer is enough to be considered a foil given the broadest reasonable interpretation.
Regarding claim 17, Pastoor discloses the self-wetting electrode of claim 9 (see rejection above), wherein the skin contact layer (Fig. 1; the layer of the electrode body 102 between the skin 104 and the electrode body 102) comprises a polymer, plastic, or rubber material (abstract; “The electrode body (102) includes a conductive silicone material,” and a conductive filler dispersed substantially evenly throughout the polymer, plastic, or rubber material (para. [0031]; “the soap or detergent are mixed with the conductive silicone material to form a homogeneous material”) Due to the indefinite language in claim 17 (see 102 rejection), it is interpreted that the mixing of the “soap or detergent” with the “silicone material” is “dispersed substantially evenly” since they “form a homogeneous material.”
Regarding claim 21, Pastoor discloses the self-wetting electrode from claim 9 (see rejection above) wherein the skin contact layer (Fig. 1; the layer of the electrode body 102 between the skin 104 and the electrode body 102) comprises a thickness of between 0.5mm and 10mm (para. [0047]; “hydrophilic silicone material (with detergent additives) sheet may have a thickness of 1 millimeter”).
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.
42. Claim(s) 1-4 and 5-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pastoor et al. (US 20180116546 A1, “Pastoor”) in view of Ziebell (“Technical Presentation: Third-Stream Additives that Modify LSR and HCR,” November 13, 2020 [online][Retrieved December 4, 2025]; RDAbott webpage; hyperlink titled “presentation”; [https://rdabbott.com/wp-content/uploads/2020/11/ISC2020-Third-Stream-Additives-for-LSR-and-HCR_20201113.pdf], pg. 20, pg. 23).
43. Regarding claim 1, Pastoor discloses a self-wetting electrode (Fig. 1; para. [0026]; “an electrode body”; para. [0033]; “the dry silicone electrode”) for transcutaneous electrical stimulation (para. [0043; used for transcutaneous nerve stimulation”) comprising: a conductive backing layer (Fig. 1; the layer between 110 and 102; para. [0044]; “Electrical coupling 110 is electrically coupled to electrode body 102 such that it enables electrical signals to be received and/or transmitted from and/or to skin 104; In some embodiments, additional components and/or layers of material are disposed between electrical coupling 110 and/or electrode body 102”); and a skin contact layer (Fig. 1; the layer of the electrode body 102 between the skin 104 and the electrode body 102) disposed on the conductive backing layer, the skin contact layer configured to deliver electrical current from the conductive backing layer to the skin for transcutaneous electrical stimulation (Fig. 1; the layer between the skin 104 and the electrode body 102; para. [0044]; "enables electrical signals to be received and/or transmitted from and/or to skin 104"), the skin contact layer comprising an antistatic material (para. [0027]; the detergent in the electrode body 102; "electrode body 102 includes silicone material, electrical conductive particles, and detergent") configured to form a layer of conductive lubricant (para. [0032]; "the detergent is configured to absorb more than 20% by weight of water. The interaction of water with the ions (added by the detergent) is configured to function as a salt-bridge"; the salt-bridge formed is a layer between the skin 104 and the electrode body 102) when the skin contact layer (Fig. 1; the layer between the skin 104 and the electrode body 102) is in contact with a heat source (Fig. 1; electrode body 102 is shown in contact with the skin 104, which is a part of the body 106 (which is a source of heat). However, Pastoor does not disclose wherein the antistatic material is configured to bloom to a skin facing surface of the skin contact layer).
44. Ziebel, in a power point presentation publicly available on RDAbbott’s webpage, discloses silicone material additives that self-lubricate and are antistatic. Ziebel, in the same field of endeavor as modified materials for wearable medical technology, discloses wherein the antistatic material (slide 20; “NovaSperse ®” “Silicone surface modification – antistatic”) is configured to bloom to a skin facing surface of the skin contact layer (slide 23; NovaSperse ® modifiers invisibly blooms to the surface (of the silicone”; see fig. below).
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45. It would have been obvious for one of ordinary skill in the art to implement the antistatic detergent at the electrode/skin interface of Pastoor with the antistatic material configured to bloom to the surface of Ziebel since doing so would apply the known blooming technique of Ziebel to improve the electrode technology of Pastoor. Additionally, the blooming technology would have been obvious since Pastoor is also trying to achieve the result of lubricating the skin contact surface between the skin and electrode with a conductive material, and Ziebel’s antistatic is known to both lubricate and bloom to the surface. Lastly, incorporating the blooming technique would improve Pastoor’s technique for achieving an electrolyte-bridge between the skin and electrode.
46. Regarding claim 2, the Pastoor and Zeibel combination discloses the self-wetting electrode combination of claim 1 (see above). Further, Pastoor discloses wherein the skin facing surface is not coated with hydrogel or liquid (Fig. 1; para. [0026]; "dry silicone electrode"; para. [0004]; " Dry electrodes rely on the natural salt and/or sweat on the skin of the subject to provide a flow path for the electrical signals transmitted to and/or received from the skin of the subject"; dry electrodes are not coated with hydrogel or liquid).
47. Regarding claim 3, the Pastoor and Zeibel combination discloses the self-wetting electrode combination of claim 1 (see above). Further, Pastoor discloses wherein the skin contact layer comprises silicone (Fig. 1; para. [0026];" Electrode body 102 includes a conductive silicone material").
48. Regarding claim 4, the Pastoor and Zeibel combination discloses the self-wetting electrode combination of claim 1 (see above). Further, Pastoor discloses wherein the antistatic material is incompatible with silicone (para. [0031]; “the soap or detergent are mixed with the conductive silicone material to form a homogeneous material”; para. [0026]; “a detergent configured to facilitate a flow of ions through the conductive silicone material”; the incompatibility of the detergent in the silicone causes the change of silicone’s properties to increase conductivity). Further, due to the indefiniteness of the applicant’s recitation of “the antistatic material is incompatible with the silicone,” it is unclear in what way the antistatic material and silicone are compatible. Thus, the claim understood with the broadest reasonable interpretation.
49. Regarding claim 6, the Pastoor and Zeibel combination discloses the self-wetting electrode combination of claim 1 (see above). Further, Pastoor discloses wherein the heat source is body heat of the user (Fig. 1; electrode body 102 is shown in contact with the skin 104, which is a part of the body 106 (which is a source of heat); para. [0034]; “the modified silicone is configured to absorb/drag water from sweat in contact with the skin.”; the heat from the body induces sweat, which is absorbed by the detergent).
50. Regarding claim 7, the Pastoor and Zeibel combination discloses the self-wetting electrode combination of claim 1 (see above). Further, Pastoor discloses wherein the antistatic material forms a layer of conductive lubricant (para. [0032]; "the detergent is configured to absorb more than 20% by weight of water. The interaction of water with the ions (added by the detergent) is configured to function as a salt-bridge"; the salt-bridge formed is a layer between the skin 106 and the electrode body 102) when the self-wetting electrode (Fig. 1; the layer between the skin 104 and the electrode body 102) is placed on a desired location of the user’s skin (Fig. 1; electrode body 102 is shown in contact with the skin 104). However, Pastoor does not specifically describe the antistatic material configured to bloom to a skin facing surface of the skin contact layer.
51. Ziebel, in a power point presentation presented at the 2020 International Silicone Conference, discloses silicone material additives that self-lubricate and are antistatic. Ziebel, in the same field of endeavor as modified materials for wearable medical technology, discloses wherein the antistatic material (slide 20; “NovaSperse ®” “Silicone surface modification – antistatic”) is configured to bloom to a skin facing surface of the skin contact layer (slide 23; NovaSperse ® modifiers invisibly blooms to the surface (of the silicone”; see fig. below).
52. It would have been obvious for one of ordinary skill in the art to combine the electrode of Pastoor with the antistatic material configured to bloom to the surface of Ziebel since doing so would use the known blooming technique of Ziebel to improve the electrode technology of Pastoor. Additionally, the blooming technology would have been obvious since Pastoor is also trying to achieve the goal of lubricating the skin contact surface between the skin and electrode, and Ziebel’s antistatic is known to both lubricate and bloom to the surface. Further, it would have been obvious to configure the antistatic material to bloom when it comes into contact with the user’s skin since doing so would prevent unwanted blooming when the electrode is not in with the user’s skin (i.e. when they don’t have an electrode placed on their skin).
53. Regarding claim 8, the Pastoor and Zeibel combination discloses the self-wetting electrode combination of claim 1 (see above). Further, Pastoor discloses wherein the antistatic material ((para. [0027]; the detergent in the electrode body 102; "electrode body 102 includes silicone material, electrical conductive particles, and detergent") stops blooming to the skin facing surface after the layer of conductive lubricant (para. [0007]; “the electrolytic sweat layer accumulates between the skin and the dry electrode”) after the layer of conductive lubricant (para. [0032]; "the detergent is configured to absorb more than 20% by weight of water. The interaction of water with the ions (added by the detergent) is configured to function as a salt-bridge"; the salt-bridge formed is a layer between the skin 104 and the electrode body 102) covers substantially all of the area (para. [0032]; “the detergent is configured to absorb water”; when the entire area and depth of the interface has absorbed water, it will reach its limit and stop. The salt-bridge layer will form on the electrode body 102 and skin 104 interface) of the skin facing surface (Fig. 1; the interface between the skin 104 and the electrode body 102).
54. Claim(s) 16 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Pastoor et al. (US 20180116546 A1, “Pastoor) in view Wong et al. (US 2019/0134393 A1, “Wong”).
55. Alternatively, Regarding claim 16, while the Examiner contends Pastoor discloses a metallic foil, in the event Applicant intends for some structure other than a thin layer of metal, it is noted that:
56. Wong, in the same field of endeavor of wearable transcutaneous electrical stimulation devices, discloses a dry electrode worn on the wrist for treating tremors. Wong discloses wherein the conductive backing layer comprises a metal foil (para. [0027]; “In some embodiments, the conductive backing layer of the dry electrodes may include a metal foil.”)
57. It would have been obvious for one of ordinary skill in the art to combine the metal foil of Wong’s conductive backing layer with electrode body of Pastoor since doing so would enable transfer of electricity between layers. Further, by using a foil, the layer would still be thin enough to enable the electrode conformity over a user’s wrist while maintaining the structural integrity necessary to conduct between layers.
58. Regarding claim 22, Pastoor discloses the self-wetting electrode of claim 9 (see 102 rejection above). However, Pastoor does not disclose wherein the skin contact layer has a Shore hardness between about 35 A to about 65 A.
59. Wong, in the same field of endeavor of wearable transcutaneous electrical stimulation devices, discloses wherein the skin contact layer has a Shore hardness between about 35 A to about 65 A (para. [0025]; “The skin contact layer may have a Shore hardness between about 25 A to about 55 A”; para. [0044]; “The skin contact layer has a Shore A durometer of between about 30 A and about 50 A”).
60. It would have been obvious for one of ordinary skill in the art to combine the Shore hardness for the skin contact layer in Wong in the electrode body of Pastoor since doing so would result in adequate flexibility that allows the electrode to conform to the user’s wrist. It would have been obvious to try a Shore hardness within this range for the skin contact layer since the skin contact layer needs to be flexible enough to conform to the user’s wrist while still maintaining the structural integrity of the electrode.
61. Additionally, it should be noted that, due to the indefiniteness of the claim language, the Shore hardness range of Wong (25A to 55A) can be interpreted as being within the range of about 35A to about 65A since it is not clear what is “about 35A” or “about 65A.”
62. Alternatively, in the event the applicant intends to use the exact range from 35A to 65A, Pastoor and Wong disclose a Shore hardness from 25A to 55A, but do not disclose the exact range from 35A to 65A. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use a Shore hardness of 35A to 65A, since it has been held that where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. In re Wertheim, 191 USPQ 90.
63. Claim(s) 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Pastoor et al. (US 20180116546 A1, “Pastoor) in view of Karicherla et al. (US 2009/0249617, hereinafter referred to as “Karicherla”).
64. Regarding claim 18, the Pastoor discloses the self-wetting electrode of claim 17 (see above in 102 rejection). However, the Pastoor does not disclose wherein the conductive filler material comprises of single wall carbon nanotubes.
65. Karicherla discloses an implantable lead with antistatic material coating comprising carbon nanotubes. Karicherla, in the same field of endeavor as Pastoor of bioelectrical materials, discloses wherein the conductive filler material (para. [0011]; “good dispersion of the carbon nanotubes in the matrix”; shows that the nanotubes are fillers in the material matrix) comprises of single wall carbon nanotubes (para. [0029]; “The carbon nanotubes are highly conductive and therefore a very small loading of this material in a polymer such as those described above is sufficient to dissipate a build up of static charges”).
66. It would have been obvious for one of ordinary skill in the art to combine the carbon nanotubes of Karicherla with the electrode of Pastoor since doing so would enhance the antistatic properties of the silicone electrode. Further, doing so would prevent the build up of static charges, which is undesirable for the sensitive circuitry described in Pastoor since static build up can damage or melt insulating materials.
67. Regarding claim 19, Pastoor and Karicherla, in combination, disclose the limitations of the self-wetting electrode of claim 18. Further, Karicherla discloses wherein a loading of the single wall carbon nanotubes is between about 1% and about 5% (para. [0011]; Still further, preferably, the coating may comprise a carbon nanotube loading of 0.005% to 4.5%, by weight). (overlap; since .005 is outside the claimed range; make the case that the end range (4.5) falls within the range (check MPEP obviousness of ranges)).
68. It would have been obvious for one of ordinary skill in the art to combine the carbon nanotubes of Karicherla with the electrode of Pastoor since doing so would enhance the antistatic properties of the silicone electrode. Further, doing so would prevent the buildup of static charges, which is undesirable for the sensitive circuitry described since static build up can damage or melt insulating materials. Further, it would also have been obvious to load the material in this specific range since these loading percentages prevent undesirable effects, such as nanotube agglomeration.
Conclusion
69. Any inquiry concerning this communication or earlier communications from the examiner should be directed to OWEN LEWIS MARSH whose telephone number is (571)272-8584. The examiner can normally be reached 7:30am – 5pm (M-Th) or 8am – 1pm (F).
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/OWEN LEWIS MARSH/Examiner, Art Unit 3796
/ALLEN PORTER/Primary Examiner, Art Unit 3796