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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-11 in the reply filed on 12/8/2025 is acknowledged.
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.
Claims 1, 2, 10 and 11 are rejected under 35 U.S.C. 102(a)(1) and (2) as being anticipated by Munro et al. (US 2006/0029652, hereinafter “Munro ‘652”).
In regards to claim 1, Munro ‘652 discloses an assembly (par. 0132; biomedical electrode in combination with the hydrogel at the skin-electrode interface), comprising:
at least one electrode (pars. 0044, 0132; “The compositions prepared according to the present invention are used in biomedical electrodes in generally conventional manner”); and
a foamed conductive hydrogel (abstract; “The invention provides an absorbent (porous) hydrogel composition comprising a foam portion which comprises a flexible plasticised hydrophilic polymer matrix having an internal cellular structure”) for placement between the at least one electrode and a patient's skin (pars. 0043, 0044, 0132; “The porous hydrogel compositions used in this invention may be electrically conductive and constitute a skin-contactable, preferably adhesive, portion of a biomedical electrode. Such a hydrogel composition will typically provide good current dispersion over the skin-electrode interface”), the foamed conductive hydrogel having a first surface and a second surface, wherein the first surface of the foamed conductive hydrogel is connected to the at least one electrode, and the second surface of the foamed conductive hydrogel is for application to the patient's skin (pars. 0043, 0044, 0132; “The porous hydrogel compositions used in this invention may be electrically conductive and constitute a skin-contactable, preferably adhesive, portion of a biomedical electrode. Such a hydrogel composition will typically provide good current dispersion over the skin-electrode interface”), the foamed conductive hydrogel being polymerized (abstract, “The invention provides an absorbent (porous) hydrogel composition comprising a foam portion which comprises a flexible plasticised hydrophilic polymer matrix having an internal cellular structure”).
In regards to claim 2, the assembly further comprising a liner disposed on the foamed conductive hydrogel and covering at least a portion of the second surface of the foamed conductive hydrogel (par. 0031, “The sheet material is preferably adapted to constitute a release layer for protecting the skin-contactable surface of the polymerised hydrogel composition prior to use”).
In regards to claim 10, the foamed conductive hydrogel necessarily has a density less than a solid conductive hydrogel because it includes the gel gassed with bubbles of a gas such as air (par. 0052).
In regards to claim 11, the foamed conductive hydrogel is one or more of a closed-cell foam or an open-cell foam (par. 0049, “the porous portion of the hydrogel composition, may be closed-cell throughout, open-cell throughout, or may have regions of closed-cell structure and regions of open-cell structure”).
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.
Claims 3-9 are rejected under 35 U.S.C. 103 as being unpatentable over Munro ‘652 in view of Munro et al. (US 2006/0251880, hereinafter “Munro ‘880”).
In regards to claims 3 and 4, Munro ‘652 discloses the essential features of the claimed invention, including utilizing a polymerized conductive hydrogel (abstract, par. 0044), but does not expressly disclose the assembly further comprises a hydrogel between the first surface of the foamed conductive hydrogel and the at least one electrode, wherein the polymerized conductive hydrogel is devoid of perforations. However, Munro ‘880 in the same field of endeavor of hydrogel layers for biomedical electrodes teaches providing a hydrogel between the first surface of the foamed conductive layer and the at least one electrode, wherein the hydrogel is devoid of perforations (e.g., Fig. 2, element 4, par. 0107 “additional continuous hydrogel layer”) to provide the predictable results of locking away excess moisture absorbed into the absorbent layer (par. 0110). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Munro ‘652 by providing a hydrogel between the first surface of the foamed conductive layer and the at least one electrode, wherein the hydrogel is devoid of perforations to provide the predictable results of locking away excess moisture absorbed into the absorbent layer.
In regards to claim 6, Munro ‘652 discloses that the polymerized conductive hydrogel comprises at least one modification that extends inwardly or outwardly from the second surface thereof (pars. 0021, 0030-0031; “The apertures of the second portion of the hydrogel composition may continue into the first portion of the composition and thus invade it to some extent. However, they preferably do not penetrate the first portion of the hydrogel entirely”).
In regards to claim 7, Munro ‘652 discloses that the at least one modification is selected from the group consisting of:
a perforation extending inwardly from the second surface to the first surface thereof and through the polymerized conductive hydrogel;
a recess, channel, or well extending inwardly from the second surface of the polymerized conductive hydrogel (pars. 0021, 0030-0031; “The apertures of the second portion of the hydrogel composition may continue into the first portion of the composition and thus invade it to some extent. However, they preferably do not penetrate the first portion of the hydrogel entirely”);
a plurality of protrusions extending outwardly from the second surface thereof, and wherein two or more protrusions form a recess, channel, or well therebetween;
and combinations thereof.
In regards to claim 8, Munro ‘652 discloses that at least a portion of the foamed conductive hydrogel is disposed in or associated with the at least one modification (pars. 0021, 0030-0031; “The apertures of the second portion of the hydrogel composition may continue into the first portion of the composition and thus invade it to some extent. However, they preferably do not penetrate the first portion of the hydrogel entirely”; the foamed hydrogel being the first portion).
In regards to claim 9, Munro ‘652 discloses that the polymerized conductive hydrogel comprises a plurality of modifications that extend inwardly or outwardly from the second surface thereof, and wherein at least a portion of the plurality of modifications has foamed conductive hydrogel disposed therein or associated therewith (pars. 0021, 0030-0031; “The apertures of the second portion of the hydrogel composition may continue into the first portion of the composition and thus invade it to some extent. However, they preferably do not penetrate the first portion of the hydrogel entirely”; the foamed conductive hydrogel is within the apertures).
In regards to claim 5, Munro ‘652 discloses the essential features of the claimed invention except for a conductive foam disposed between the first surface of the conductive hydrogel and the at least one electrode, the conductive foam having a solid continuous phase material constructed of a conductive material, and defining a plurality of pockets interspersed throughout the solid continuous phase material, the foamed conductive hydrogel disposed within at least a portion of the pockets, the conductive foam being one or more of an open cell foam or a closed cell foam. However, Munro ‘880 in the same field of endeavor of hydrogel interfaces for biomedical electrodes teaches providing a conductive foam disposed between the first surface of the conductive hydrogel and the at least one electrode, the conductive foam having a solid continuous phase material constructed of a conductive material (pars. 0011-0013, the polyurethane foam is in a solid continuous phase and the layer is conductive per par. 0044), and defining a plurality of pockets interspersed throughout the solid continuous phase material, the foamed conductive hydrogel disposed within at least a portion of the pockets, the conductive foam being one or more of an open cell foam or a closed cell foam (pars. 0050, 0053, integrally forming the two layers with the first layer being porous allows the hydrogel to dispose within the “pockets”/pores; par. 0049, “the porous portion of the hydrogel composition, may be closed-cell throughout, open-cell throughout, or may have regions of closed-cell structure and regions of open-cell structure”) to provide the predictable results of the strength and absorbability afforded by a solid phase material (abstract, par. 0016) with the flexibility and tackiness afforded by a hydrogel in a composite structure (par. 0016). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Munro ‘652 by providing a conductive foam disposed between the first surface of the conductive hydrogel and the at least one electrode, the conductive foam having a solid continuous phase material constructed of a conductive material, and defining a plurality of pockets interspersed throughout the solid continuous phase material, the foamed conductive hydrogel disposed within at least a portion of the pockets, the conductive foam being one or more of an open cell foam or a closed cell foam to provide the predictable results of the strength and absorbability afforded by a solid phase material with the flexibility and tackiness afforded by a hydrogel in a composite structure.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Andrews (US 2017/0189238) is another example of a biomedical electrode utilizing a foamed hydrogel.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL W KAHELIN whose telephone number is (571)272-8688. The examiner can normally be reached M-F, 8-5.
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/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792