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 Arguments
Applicant's arguments filed January 21, 2026 have been fully considered but they are not persuasive.
Applicant argues that “Giuntoli is explicitly and exclusively directed to hydrogel- based coupling layers. Giuntoli repeatedly and consistently describes their invention as a hydrogel pad or patch (see, e.g., paragraphs [0003]-[0006], [0029]-[0042]). Giuntoli's conductive medium relies on ionic conduction through hydrogel, not on a conductive filler embedded within a solid elastomeric matrix” (page 8 of Remarks/Arguments).
However, Giuntoli discloses “hydrogel patch 9 comprising of hydrogel dots or spheres 10 secured to a scrim 11. The scrim is made of a sufficiently porous material having a top surface 12 and a bottom surface 13. The scrim is a finely woven, nonconductive mesh of polyester, nylon, polyamide or similar materials” ([0029]). Therefore, Giuntoli does in fact disclose a conductive filler (hydrogel) embedded within a conductive material.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a conductive filler embedded within a solid elastomeric matrix) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Additionally, the Applicant argues that “Claim 1 further requires that the conductive material within the elastomeric body is configured to distribute electrical current uniformly across the electrodes. As supported by the specification, this uniformity is achieved through engineered impedance characteristics of the elastomeric body (e.g., filler type, density, orientation, and/or layer conductivity)” (page 8 of Remarks/Arguments). The examiner respectfully disagrees. Claim 1 recites “the conductive material in the body of the elastomeric material of the interface pad is configured to distribute electrical current uniformly across the electrodes by providing a predetermined impedance characteristic across an electrode-facing area of the interface pad”. There is no recitation of “engineered impedance characteristics of the elastomeric body (e.g., filler type, density, orientation, and/or layer conductivity)”.
Therefore, for the reasons stated above, the claims remain rejected under Giuntoli et al. as detailed below.
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.
Claims 1-22 are 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.
Claim 1 now recites “the interface pad comprising non-hydrogel body of elastomeric material”. While the specification discloses “drawbacks associated with conventional hydrogel pads”, the specification does not explicitly disclose “the interface pad comprising non-hydrogel body of elastomeric material”.
Additionally, claim 4 now recites “elastomeric material deforms elastically onto the electrodes to for a moisture-proof seal”. While the specification recites “The electrodes 50, 60 can be shielded from moisture by the interface pad 100, which covers the electrodes” ([0049] of US 2024/0207606 A1) , there is no support in the specification for creating a “moisture-proof seal”.
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.
Claims 1, 8-14 and 16-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Giuntoli et al. (US 20030069627 A1).
As to claim 1, Giuntoli et al. discloses a neurostimulator for applying electrical stimulation through a subject's skin ([0001, 0027]) comprising: a wearable configured to be worn by the subject (strap, depicted as 7 in Figure 1); a control unit (housing, depicted as 2 in Figures 1-3) connected to the wearable (Figure 1); electrodes (depicted as 3 in Figures 1-3, 4b-4c and 5b) mounted on the wearable (Figure 1) and electrically connected to the control unit ([0027-0028]); an interface pad (hydrogel pad or patch, depicted as 9 in Figures 3-4a) overlying the electrodes (Figure 3, [0028]), wherein the interface pad is configured to be positioned on the subject's skin ([0028]), the interface pad being configured to conduct electrical signals between the electrodes and the subject's skin ([0028]), the interface pad comprising a non-hydrogel body of elastomeric material ([0029, 0032, 0037]; “hydrogel patch 9 comprising of hydrogel dots or spheres 10 secured to a scrim 11. The scrim is made of a sufficiently porous material having a top surface 12 and a bottom surface 13. The scrim is a finely woven, nonconductive mesh of polyester, nylon, polyamide or similar materials” [0029]) impregnated or embedded with an electrically a conductive material (hydrogel; [0029]; The scrim is composed of a “non-hydrogel body” of elastomeric material that supports and is embedded with an e conductive material (i.e., the hydrogel dots or spheres)); and wherein the interface pad is mounted on the wearable so that the interface pad covers the electrodes (Figure 3, [0028]), wherein the conductive material in the body of the elastomeric material of the interface pad is configured to distribute electrical current uniformly across the electrodes ([0006, 0028]) by providing a predetermined impedance characteristic across an electrode-facing area of the interface pad ([0028]; “the hydrogel pad contacts the pair of electrodes and provides a conductivity enhancing layer (sometimes referred to as an impedance matching layer) between the device and the user's skin”[0028]).
As to claim 8, Giuntoli et al. discloses the body of elastomeric material comprises a body of silicone material ([0042]).
As to claim 9, Giuntoli et al. discloses the conductive material comprises conductive foam ([0029, 0037, 0042]).
As to claim 10, Giuntoli et al. discloses the body of elastomeric material comprises a single layer sheet of silicone and the conductive material comprises conductive particles embedded in the sheet of silicone ([0042]), wherein the particles are configured so that an impedance across an area of the interface pad is uniform ([0003, 0006, 0028]), the uniformity of the impedance being determined through the type of conductive material, the density of the conductive material in the body of elastomeric material, the orientation of filler material particles in the body of elastomeric material, or a combination thereof ([0003, 0006, 0028, 0042]).
As to claim 11, Giuntoli et al. discloses the interface pad has a multi-layered construction including at least one low conductivity layer and at least one high conductivity layer ([0006]).
As to claim 12, Giuntoli et al. discloses the conductivity of the layers ([0006]) can be determined by the type of filler material in each layer, the amount or density of filler material in each layer, the orientation of filler material particles in each layer, or a combination thereof ([0006, 0032-0033, 0037, 0041-0042]).
As to claim 13, Giuntoli et al. discloses the interface pad comprises a high conductivity layer sandwiched in between two low conductivity layers, the high conductivity layer being configured to act as a current spreader that helps spread electrical current passing into the high conductivity layer through one or more localized regions of a first of the low conductivity layers so that the current is spread evenly across the area of a second of the low conductivity layers ([0006, 0032-033, 0037, 0041-0042]).
As to claim 14, Giuntoli et al. discloses the first low conductivity layer is configured to interface with the electrodes and the second low conductivity layer is configured to interface with the subject's skin ([0006, 0042]; Figures 3, 4a-7d and 9), the interface pad being configured to deliver stimulation current to the subject's skin uniformly across the interface pad from localized areas where the electrodes interface the first layer ([0006, 0042]; Figures 4a-7d & 9).
As to claim 16, Giuntoli et al. discloses the conductive material comprises conductive particles embedded in the body of elastomeric material, the particles being oriented with a bias to produce at least one of a predetermined conductive pathway and a predetermined non-isotropic conductivity ([0006, 0028, 0032-0033, 0037, 0041-0042]).
As to claim 17, Giuntoli et al. discloses the conductive particles embedded in the body of elastomeric material are biased to an orientation at a predetermined angle relative to the thickness of the body of elastomeric material (Figures 4a-7d and 9).
As to claim 18, Giuntoli et al. discloses the interface pad comprises multiple layers of elastomeric material ([0006]), each having conductive particles biased to a predetermined orientation configured so that the interface pad as a whole displays predetermined conductivity and/or impedance characteristics (Figures 4a-7d and 9).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 4-7 and 19-22 are rejected under 35 U.S.C. 103 as being unpatentable over Giuntoli et al. (US 20030069627 A1).
As to claim 4, as best understood in light of the rejection under 35 U.S.C. 112 above, Giuntoli et al. discloses a structure (carrier, depicted as 16 in Figures 5a-5b, 7a-7d and 9) for securing the interface pad to the wearable, the structure being configured to urge the interface pad into engagement with the electrodes so that the body of elastic material deforms elastically onto the electrodes to form a seal that seals the electrodes behind the body of elastomeric material ([0006, 0032-0033, 0037, 0041-0042]) but does not explicitly disclose the engagement forms “a moisture-proof seal”. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the engagement to form a “moisture proof seal” in order to provide the predictable results of ensure the integrity of the electrical connection with the subject’s skin and prevent degradation of materials and electrical connectivity in the presence of outside moisture.
As to claim 5, the modified Giuntoli et al. discloses the structure is configured to urge the interface pad uniformly against the electrodes in so that the interface pad exhibits uniform conductivity across the electrodes ([0032-0033, 0037]).
As to claim 6, the modified Giuntoli et al. discloses the structure comprises a snap-fit structure ([0006, 0032-0033, 0037, 0041-0042]) including an electrode-associated component secured to the wearable and an interface pad-associated component that engages and supports the body of elastomeric material ([0001, 0004, 0029]), wherein the interface pad-associated component is connectable to the electrode-associated component via a snap-fit ([0006, 0032-0033, 0037, 0041-0042]).
As to claim 7, the modified Giuntoli et al. discloses the electrode-associated component and the interface pad-associated component are configured so that the interface pad is urged against and deformed into engagement with the electrodes when the snap-fit connection is established ([0001, 0004, 0029]).
As to claim 19, Giuntoli et al. discloses the invention substantially as claimed with an interface pad comprises multiple elastomeric layers with conductive particles embedded therein, but does not explicitly disclose “the multiple layered structure being configured to provide higher interstitial capacitance in order to block DC current in the interface pad”. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the multiple layered structure of the interface pad to have a “higher interstitial capacitance in order to block DC current” in order to provide the predictable results of optimizing function and treatment to meet specific patient therapeutic needs and requirements.
As to claim 20, Giuntoli et al. discloses the invention substantially as claimed with a conductive hydrogel but does not explicitly disclose the embedding a dry electrolyte in one or more of the elastomeric layers, wherein the dry electrolyte being configured to provide a desired ionization response. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the multiple layered structure of the interface pad to have an “embedded dry electrolyte in one or more of the elastomeric layers”, “wherein the dry electrolyte being configured to provide a desired ionization response” in order to provide the predictable results of optimizing function and treatment to meet specific patient therapeutic needs and requirements.
As to claim 21, Giuntoli et al. discloses “A suitable hydrogel is sold under the tradename Ludlow 62D, available from Ludlow Technical Products. This hydrogel is a moderately conductive hydrogel and has moderate adhesive qualities. The gel typically has an adhesive quality which makes easily releasable and applicable to the electrodes without need for tools”([0029]). Therefore, Giuntoli et al. discloses “adhesive-free use” since the hydrogel has adhesive qualities but is not in itself an “adhesive”. Giuntoli et al. discloses the invention substantially as claimed but does not explicitly discloses “the interface pad is washable and resuable”. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the interface pad to be able to be reused (i.e., by being able to clean or wash the scrim and redeposit hydrogel into the scrim) in order to provide the predictable results of reducing waste generated by disposable pads.
As to claim 22, Giuntoli et al. discloses the employment of silicone material ([0042]) but does not explicitly disclose the silicone has a Shore A hardness in the range of 30 to 70. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the silicone to have a Shore A hardness in the range of 30 to 70, 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 MPEP 2144.07) Furthermore, such a modification would provide the predictable results of optimizing the device performance to meet specific patient therapeutic needs and requirements.
Claims 2 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Giuntoli et al. (US 20030069627 A1) in view of Schaefer et al. (US 5203330).
As to claim 2, Giuntoli et al. discloses the electrodes comprise stimulation electrodes and the interface pad is configured to deliver electrical stimulation signals from the stimulation electrodes to the subject's skin ([0006, 0027-0028]) and electrodes in contact with the interface pad (Figure 3) that provide stimulation ([0006]). Giuntoli et al. discloses the invention substantially as claimed with electrodes but does not explicitly disclose electrodes with recording capabilities for recording EMG response signals. Schaefer et al. dual-purpose electrodes used for both stimulation and EMG sensing (col. 1, lines 58-64). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the stimulation electrodes of Giuntoli et al. to be sensing and recording electrodes as disclosed by Schaefer et al. in order to provide the predictable results of incorporating diagnostic capabilities in order optimize treatment to meet specific patient therapeutic neuromuscular needs and requirements.
As to claim 15, the modified Giuntoli et al. discloses the first low conductivity layer is configured to interface with the subject's skin and the second low conductivity layer is configured to interface with the electrodes the interface pad being configured to distribute localized EMG response current from the subject's skin uniformly across the interface pad to the electrodes interfacing the second layer ([0006, 0033, 0042]; Figures 4a-7d and 9-10).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA M ALTER whose telephone number is (571)272-4939. The examiner can normally be reached M-F 8am-4pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David E Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALYSSA M ALTER/Primary Examiner, Art Unit 3796
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