DETAILED ACTION
This action is responsive to the application filed 4/11/22.
Claims 1-8 are rejected.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-8 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 1, it is not clear how the recited electrode could comprise a ‘skin contact surface’ if the ‘coupling member’ is recited to be placed between the electrode and the skin.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-2 and 4-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grob et al. (US 20130197341, “Grob”) in view of Taverner et al. (2014), Transcutaneous Pulsed Radiofrequency Treatment for Patients with Shoulder Pain Booked for Surgery: A Double-Blind, Randomized Controlled Trial. Pain Pract, 14: 101-108.
Regarding claim 1, Grob teaches a coupling arrangement (Abstract, “An electrode configured to provide electrical contact with a subject's skin and includes a conductive layer and a gel layer.”), comprising a coupling member configured to be arranged on a skin contact surface of an electrode (Fig. 4, the coupling member can be considered the combination of current spreader 36 and gel layer 34 which are arranged on the skin facing surface of conductive layer 74) skin treatment device for electrically coupling the electrode to a skin of a user (Abstract, “The gel layer has a first interface surface that directly contacts the subject's skin if the electrode is installed on the subject, and to conduct electrical signals between the subject's skin and the first conductive surface.”), wherein: the coupling member comprises a first layer of a first electrically conductive material configured to be arranged on the skin contact surface via a first side of the first layer (Fig. 4, conductive layer 36 disposed on a skin facing surface of conductive layer 74; par. 33, “The conductive layer 36 may be made of, just for example, metallic foils, conductive polymers, graphitized or metalized cloth or wire mesh.”), the coupling member comprises a second layer of a second electrically conductive material, different from the first electrically conductive material (Fig. 4, gel layer 34 is a different material than conductive layer 36; par. 6, “The gel layer has a first interface surface configured to directly contact the subject's skin if the electrode is installed on the subject, and to conduct electrical signals between the subject's skin and the first conductive surface.”), arranged on the first layer, on a second side of the first layer opposite to the first side (Fig. 4, gel layer 34 is arranged on a side the opposite side of conductive layer 36 from conductive layer 74).
Grob fails to teach that skin treatment device is a radio-frequency (RF) skin treatment device; that the first layer has a thickness in a range from 10 µm to 100 µm and the first electrically conductive material has a modulus of elasticity of at least 100 kPa, and the second layer has a thickness of 10 µm or less and the second electrically conductive material has a viscosity of 1,000 CPS or less.
Regarding the radio-frequency aspect, Taverner teaches an analogous skin treatment device for stimulating tissue, which utilizes pulsed radio-frequency energy (Abstract, “Previously, the effect of transcutaneous pulsed radiofrequency treatment (TCPRFT) was evaluated in a retrospective audit that showed good pain relief for a mean 395 days and justified this randomized sham controlled trial. In this study, 51 patients entered into a randomized double-blinded, placebo controlled study of TCPRFT.”).
Therefore, since both Grob and Taverner teach different stimulation devices for delivering transcutaneous electrical stimulation to tissue, it would have been obvious to POSITA at the time that the invention was filed to substitute one known type of transcutaneous stimulation energy for the other, in order to arrive at the predictable result of a device for providing transcutaneous stimulation energy to tissue. KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding the thickness of the layers aspect, the examiner maintains that it would have been obvious to POSITA at the time the invention was filed to optimize the thicknesses of the different conductive layers as needed, since the thicknesses of the conductive layers would have been regarded as result effective variables which affect the overall resistances of the conductive layers, and since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Further, regarding the recited elasticity and viscosity of the first and second layers, it is the examiner’s position that it would have been obvious to POSITA at the time that the invention was filed to optimize these properties, since these properties would have been considered result-effective variables which affect the ability of the device to conform to the contours of the subject’s body, and since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 2, Grob, as modified, further teaches wherein the first electrically conductive material is a solid material (Par. 28, “The conductive layer 36 may be made of, just for example, metallic foils, conductive polymers, graphitized or metalized cloth or wire mesh.”).
Regarding claim 4, Grob, as modified, further teaches wherein the first electrically conductive layer has a thickness in a range from 10 µm to 20 µm (Grob has previously been modified to optimize the thickness of the first electrically conductive layer; see the discussion of claim 1, above).
Regarding claim 5, Grob, as modified, further teaches wherein the second electrically conductive material comprises a viscous liquid (Par. 35, “The gel layer 34 may include hydrogel materials, such as, just for example, the ARBO HRA5 gel made by Covidien”; for instance, a hydrogel inherently comprises water; further, applicant’s disclosure explicitly teaches that the viscous liquid can be water-based and can include a hydrogel; see applicant’s specification, pg. 7, lines 14-17).
Regarding claim 6, Grob, as modified, further teaches wherein the second electrically conductive material comprises a solid gel, a hydrogel, and/or an ionic gel (Par. 35, “The gel layer 34 may include hydrogel materials, such as, just for example, the ARBO HRA5 gel made by Covidien”).
Regarding claim 7, Grob, as modified, fails to teach wherein the first electrically conductive material and the second electrically conductive material each have an electrical conductivity in a range from 0.01 to 0.25 S/m for an RF frequency of 1 MHz.
The examiner maintains, however, that it would have been obvious to POSITA at the time that the invention was filed to optimize the conductivities of the conductive layers, since the conductivities of the conductive layers would have been considered result-effective variables which affect the ability of the device to conduct current to and from the tissue, and since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 8, Grob, as modified, further teaches wherein a removable cover layer is arranged on the second layer, on a side of the second layer remote from the first layer (Fig. 4 and par. 30, “The electrode pad 14 may be provided with a plastic carrier or film to prevent inadvertent and/or premature adhesion of a patient's skin or other object to portions of the front layer 32. The plastic carrier may be removed prior to application of the electrode 14 to the subject's skin. The plastic carrier may be disposed on either one or both of the adhesive layer 38 and the gel layer 34 (in embodiments where the gel layer 34 is an adhesive gel).”).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grob in view of Taverner, as applied to claims 1-2 and 4-8 above, and further in view of Shoemaker (US 5974344).
Regarding claim 3, Grob, as modified, fails to teach wherein the first electrically conductive material comprises silicone rubber, polyurethane, silicone elastomer, or other elastomeric materials.
Shoemaker, however, teaches an analogous electrode (Abstract, “A wound care electrode including a flexible, electrically conductive body and an electrically conductive gel layer secured to the bottom of the electrically conductive body”) having a conductive polymer layer which comprises silicone rubber (Col. 2, lines 56-59, “The conductive body 12 is preferably formed from a thin film (approximately 0.1 mm thick) of silicone rubber or other material which has been made electrically conductive by the addition of carbon black.”).
Therefore, since both Grob and Shoemaker teach different conductive polymer layers for use in flexible medical electrodes, it would have been obvious to POSITA at the time that the invention was filed to substitute one known conductive polymer layer for the other in order to arrive at the predictable result of a conductive polymer layer for use in a flexible medical electrode. KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM JOSEPH AVIGAN whose telephone number is (571)270-3953. The examiner can normally be reached Monday-Friday 9am-5pm.
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ADAM JOSEPH. AVIGAN
Examiner
Art Unit 3739
/ADAM J AVIGAN/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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