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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12 February 2026 has been entered.
Claims 7, 9, 11-12 and 17-18 are cancelled; new claim 27 is entered; claims 1-6, 8, 10, 13-16 and 19-27 are pending.
Information Disclosure Statement
Applicant should note that the large number of references in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any particular references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action.
Response to Arguments
Applicant's arguments filed 12 February 2026 have been fully considered but they are not persuasive. Since the arguments pertain to the amendments, they will be addressed below.
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.
Claim 24 is 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. Claim 24 requires “the skin contact layer is configured to deliver electrical current having an amplitude of.” There appears to be some missing range or number here.
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 1-6, 8, 10, 13-16 and 19-27 are rejected under 35 U.S.C. 103 as being unpatentable over Sun et al (U.S. 2005/0015042). Sun discloses (par. 0009) a conductive backing layer; and a skin contact layer disposed on the conductive backing layer, wherein the skin contact layer is configured to deliver electrical current from the conductive backing layer to a skin surface via transcutaneous electrical stimulation of a peripheral nerve below the skin surface, wherein the skin contact layer comprises (par. 0075-0077) a polymer, plastic, or rubber material, and a conductive filler material dispersed throughout the polymer, plastic, or rubber material, wherein the skin contact layer comprises a skin facing surface that is not coated with a hydrogel or liquid.
Sun discloses the claimed invention except for the skin contact layer has a Shore hardness between about 10A to about 100A. It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide a skin contact layer of this hardness range, since it has been held that discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Furthermore, as stated in MPEP 2144.05(II)(B):
The Supreme Court has clarified that an "obvious to try" line of reasoning may properly support an obviousness rejection. In In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977), the CCPA held that a particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation, because "obvious to try" is not a valid rationale for an obviousness finding. However, in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007), the Supreme Court held that "obvious to try" was a valid rationale for an obviousness finding, for example, when there is a "design need" or "market demand" and there are a "finite number" of solutions. 550 U.S. at 421, 82 USPQ2d at 1397 ("The same constricted analysis led the Court of Appeals to conclude, in error, that a patent claim cannot be proved obvious merely by showing that the combination of elements was ‘[o]bvious to try.’ ... When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under §103.").
Also, per MPEP 2144.05(III)(A):
the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range." In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See also Minerals Separation, Ltd. v. Hyde, 242 U.S. 261, 271 (1916) (a patent based on a change in the proportions of a prior product or process (changing from 4-10% oil to 1% oil) must be confined to the proportions that were shown to be critical (1%)); In re Scherl, 156 F.2d 72, 74-75, 70 USPQ 204, 205 (CCPA 1946) ("Where the issue of criticality is involved, the applicant has the burden of establishing his position by a proper showing of the facts upon which he relies."); In re Becket, 88 F.2d 684 (CCPA 1937) ("Where the component elements of alloys are the same, and where they approach so closely the same range of quantities as is here the case, it seems that there ought to be some noticeable difference in the qualities of the respective alloys."); In re Lilienfeld, 67 F.2d 920, 924 (CCPA 1933) ("It is well established that, while a change in the proportions of a combination shown to be old, such as is here involved, may be inventive, such changes must be critical as compared with the proportions used in the prior processes, producing a difference in kind rather than degree."); In re Wells, 56 F.2d 674, 675, 12 USPQ 430 (CCPA 1932) ("Changes in proportions of agents used in combinations . . . in order to be patentable, must be critical as compared with the proportions of the prior processes."); E.I. DuPont de Nemours & Company v. Synvina C.V., 904 F.3d 996, 1006, 128 USPQ2d 1193, 1201 (Fed. Cir. 2018.)("[A] modification of a process parameter may be patentable if it ‘produce[s] a new and unexpected result which is different in kind and not merely in degree from the results of the prior art." (citing Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); UCB, Inc. v. Actavis Labs, UT, Inc., 65 F.4th 679, 693, 2023 USPQ2d 448 (Fed. Cir. 2023) ("A difference of degree is not as persuasive as a difference in kind – i.e., if the range produces ‘a new property dissimilar to the known property,’ rather than producing a predictable result but to an unexpected extent.").
Since the Applicant has not provided criticality for the hardness range claimed, the Examiner maintains that this is a results-effective variable that would have been obvious to one of ordinary skill in the art at the time of the invention.
With regards to the arguments previously presented, that Sun does not disclose nerve stimulation, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Furthermore, Sun discloses at least the electrical stimulation is configured to treat at least an inflammatory disease (par. 0111-0113).
Sun discloses the claimed invention except for the electrical current has an amplitude of between 1 and 25 mA. It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide an electrical current of this range, since it has been held that discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 2, Sun discloses (par. 0163) the conductive backing layer comprises a metal foil.
Regarding claim 3, Sun discloses (par. 0161) the metal foil is disposed on a flexible polymer substrate.
Regarding claim 4, Sun discloses (par. 0076) the conductive filler material comprises a powder.
Regarding claim 5, Sun discloses (par. 0076) the conductive filler material comprises metal, carbon, or a mixture thereof.
Regarding claim 6, Sun discloses (par. 0161-0163) the conductive backing layer comprises porous material treated with a conductive coating.
Regarding claim 8, Sun discloses the claimed invention except for the skin contact layer has a volume resistivity between about 1 ohm*cm and about 2000 ohm*cm. It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide a skin contact layer of this volume resistivity, since it has been held that discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 10, Sun discloses (par. 0075) the skin contact layer comprises silicone.
Regarding claim 13, Sun discloses (par. 0075) the conductive filler material comprises silver coated glass bubbles.
Regarding claims 14 and 21, Sun discloses the claimed invention except for the conductive filler material comprises single all carbon nanotubes. It would have been obvious to one of ordinary skill in the art at the time of the invention to provide a conductive filler of carbon nanotubes, 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.
Regarding claim 15, Sun discloses the claimed invention except for the loading of silver coated glass bubbles is between about 3% and about 30% of the skin contact layer. It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide a loading in this range, since it has been held that discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claims 16 and 22, Sun discloses the claimed invention except for the loading of single wall carbon nanotubes is between about 1% and about 5%, or 10%. It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide a loading in this range, since it has been held that discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 19, Sun discloses (par. 0009) a conductive backing layer; and a skin contact layer disposed on the conductive backing layer, wherein the skin contact layer is configured to deliver electrical current from the conductive backing layer to a skin surface via transcutaneous electrical stimulation of a peripheral nerve below the skin surface, wherein the skin contact layer (par. 0075-0077) comprises a polymer, plastic, or rubber material, and a conductive filler material, wherein the conductive filler material is dispersed throughout the polymer, plastic, or rubber material, wherein the skin contact layer comprises a skin facing surface, wherein the skin facing surface is not coated with a hydrogel or liquid, wherein the electrode is dry to reduce degradation and irritation.
Sun discloses the claimed invention except for the skin contact layer has a Shore hardness between about 25A to about 55A. It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide a skin contact layer of this hardness range, since it has been held that discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
With regards to the arguments previously presented, that Sun does not disclose nerve stimulation, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Sun discloses the claimed invention except for the skin contact layer comprises a thickness of between 0.5 mm and 10 mm. It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide a skin contact layer of this thickness, since it has been held that discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 20, Sun discloses (par. 0075-0077) the conductive filler material comprises carbon material.
Regarding claim 23, Sun discloses the claimed invention except for a skin contact layer of between 0.5 - 2 mm thickness. It would have been obvious to one having ordinary skill in the art at the time the invention was made to a skin contact layer of this range of thicknesses, since it has been held that discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 24, as best understood by the Examiner (see above rejection under 35 USC 112(b) or 35 USC 112, second paragraph, Sun discloses (par. 0009) the skin contact layer is configured to deliver electrical current having an amplitude of.
Regarding claim 25, Sun discloses (par. 0165) non-adhesive attachment mechanisms.
Regarding claim 26, Sun discloses (par. 0116) the dry electrode is configured to be disposed on a wearable band, and wherein the wearable band comprises a strap configured to be worn around a limb.
Regarding claim 27, Sun discloses the claimed invention except for the skin contact layer comprises a thickness of between 0.5 mm and 10 mm. It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide a skin contact layer of this thickness, since it has been held that discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEBORAH L MALAMUD whose telephone number is (571)272-2106. The examiner can normally be reached Mon - Fri 1:00-9:30 Eastern.
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/DEBORAH L MALAMUD/Primary Examiner, Art Unit 3792