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 .
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 18 and 21 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.
Claims 18 and 21 have antecedent basis issues because they are dependent on cancelled claims 17 and 20 respectively.
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.
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.
Claim(s) 1-7, 10-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gozani (US 2018/0177996 A1), In view of further Wingeier (US 2018/0256888 A1), in view of Hansen (US 6603318 B2).
Regarding claim 1, Gozani discloses A neurostimulation system, comprising: a skin electrode pad configured to be attached to an external electrostimulation electronics unit for treating a subject using transcutaneous neurostimulation therapy (eg. Para. 3, 47-49, electrode assembly 120 Fig. 1-4), the electrode pad comprising: a subject skin contact surface (eg. Para. 5, 66-68, 72); but does not disclose a rehydratable hydrophilic foam layer configured to be disposed between a neurostimulation output terminal of the electrostimulation electronics unit and the subject skin contact surface; and an electrolyte carried by the hydrophilic foam layer; and wherein the rehydratable hydrophilic foam layer is sized and shaped to be received within a receptacle of an electrode rehydrator to recurrently receive moisture from the electrode rehydrator to be rehydrated.
Wingeier teaches an electrical stimulation electrode that uses a rehydratable hydrophilic foam layer such as PVA (eg. Para. 65-68, claims 1, 3, 11-12, capable of absorbing and retaining a solution).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Gozani with the hydrophilic layer as taught by Wingeier since both are in the realm of electrical stimulation electrodes and using hydrophilic foams are well-known in the art for allowing the system to conform to different head sizes and/or prevent system pivoting (Eg. Wingeier, Para. 56).
Hansen teaches a system for determining suitability of electrode pads and reconditioning the pads with humidity (eg. Col. 6, Ln. 47 – Col. 7, Ln. 31, electrode pads can be placed in an environmental chamber).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Gozani and Wingeier with the detector and rehydrator as taught by Hansen to provide the predictable result of maintaining optimal collection of signals and deliver energy into the body (eg. Col. 1, Ln. 60 – Col. 2, Ln. 10). Gozani discloses that dry skin is a known issue that depletes the water in hydrogel electrode pads more quickly (Eg. Para. 100). While the prior art does not specifically disclose a receptacle, one of ordinary skill could make a simple substitution of using a chamber to rehydrate electrodes that fit inside of it.
Regarding claim 2, the combined invention of Gozani, Wingeier, and Hansen discloses rehydratable hydrophilic foam layer comprises polyvinyl alcohol (PVA) (Eg. Wingeier Para. 65-68).
Regarding claim 3, the combined invention of Gozani, Wingeier, and Hansen discloses wherein the rehydratable hydrophilic foam layer is configured to recurrently receive a vapor from a vaporizer configured to vaporize a liquid and to supply the vapor to the rehydratable hydrophilic foam layer (eg. Hansen Col. 6, Ln. 47 – Col. 7, Ln. 31).
Regarding claim 4, the combined invention of Gozani, Wingeier, and Hansen discloses the rehydratable hydrophilic foam layer has a thickness-to-pore-diameter ratio of at least ten to one (eg. Wingeier, Para. 68, shows tailoring pore size geometry, one of ordinary skill would have been able to arrive at a 10:1 ratio via routine optimization, see MPEP 2144.05).
Regarding claim 5, the combined invention of Gozani, Wingeier, and Hansen discloses the rehydratable hydrophilic foam layer includes an absorbent material having a water contact angle ranging between forty five degrees and fifty five degrees (eg. Hansen, Col. 6, Ln. 47 – Col. 7, Ln. 31, since the rehydration is via a vapor, the water contact angle is inherently any angle).
Regarding claim 6, the combined invention of Gozani, Wingeier, and Hansen discloses the rehydratable hydrophilic foam layer includes a polymer chain with polar end groups (eg. Wingeier Para. 65-68, PVA inherently is a polymer chain with polar hydroxyl groups at the end)
Regarding claim 7, the combined invention of Gozani, Wingeier, and Hansen discloses a substrate layer disposed between the neurostimulation output terminal of the electrostimulation electronics unit and the rehydratable hydrophilic foam layer (eg. Gozani, Para. 11-12, 56-65, 69).
Regarding claim 10, the combined invention of Gozani, Wingeier, and Hansen discloses the electrode rehydrator, and wherein: the electrode rehydrator is configured to supply moisture to recurrently rehydrate the neurostimulation skin electrode pad (eg. Hansen, Col. 6, Ln. 47 – Col. 7, Ln. 31).
Regarding claim 11, the combined invention of Gozani, Wingeier, and Hansen discloses the electrostimulation electronics unit, and wherein:the electrostimulation electronics unit is configured to be attached the neurostimulation skin electrode pad, and the electrostimulation electronics unit comprises: at least one neurostimulation output terminal configured for delivering neurostimulation to a subject via the at least one neurostimulation skin electrode pad (eg. Abstract, claim 1, Fig. 4, Para. 69).
Regarding claim 12, the combined invention of Gozani, Wingeier, and Hansen discloses a system controller configured to control water transfer from the electrode rehydrator and to the electrode pad (eg. Gozani Para. 100-101 control and detection combined with Hansen, Col. 6, Ln. 47 – Col. 7, Ln. 31).
Regarding claim 13, the combined invention of Gozani, Wingeier, and Hansen discloses the system controller is configured to impede water transfer upon detection of a moisture content of the electrode pad being greater than a predetermined value (eg. Hansen, Col. 6, Ln. 47 – Col. 7, Ln. 31).
Regarding claim 14, the combined invention of Gozani, Wingeier, and Hansen discloses the system controller is configured to impede water transfer upon detection of an electrical impedance of the electrode pad being less than a predetermined value (eg. Gozani, Para. 47, 86-87, 123-124).
Regarding claim 15, the combined invention of Gozani, Wingeier, and Hansen discloses the electrode rehydrator includes or is connected to a vaporizer configured to vaporize a liquid and to supply vapor to the electrode pad (eg. Hansen, Col. 6, Ln. 47 – Col. 7, Ln. 31, simple substitution with chamber as taught by Hansen).
Claim(s) 16, 18-19, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gozani (US 2018/0177996 A1), In view of further Wingeier (US 2018/0256888 A1), in view of Hansen (US 6603318 B2), further in view of Ediger (US 8544826 B2).
Regarding claim 16, the combined invention of Gozani, Wingeier, and Hansen discloses the invention of claim 10, but does not disclose the electrode rehydrator includes or is connected to a vaporizer configured to vaporize a liquid and to supply vapor to the electrode pad.
Ediger teaches an ultrasonic humidifier to produce atomized mist from a reservoir (eg. Fig. 1, Col. 2, Ln. 39-63).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Gozani, Wingeier, and Hansen with a known ultrasonic humidifier as taught by Edinger to provide a known humidifier in the art to provide the predictable result of increase the humidity inside of Hansen’s reconditioning chamber for rehydrating the electrodes.
Regarding claim 18, the combined invention of Gozani, Wingeier, Hansen, and Ediger discloses the vaporizer includes an ultrasonic mister including a ceramic diaphragm configured to vibrate the liquid (eg. Ediger, Fig. 1, Col. 1, Ln. 15-40, Col. 2, Ln. 39-63, vibrating metal diaphragm would be a simple substitute to achieve the same effect of forming an atomized mist above the surface of the reservoir).
Regarding claim 19, the combined invention of Gozani, Wingeier, Hansen, and Ediger discloses the electrode rehydrator includes a reservoir configured to supply liquid directly to the electrode pad (eg. Ediger, Fig. 1, Col. 2, Ln. 39-63, one of ordinary skill would have combined Hansen’s chamber with the humidifier source to provide the predictable result of rehydrating the electrodes).
Regarding claim 21, the combined invention of Gozani, Wingeier, Hansen, and Ediger discloses the battery charging circuitry is configured to charge the battery through at least one neurostimulation output terminal that is configured for delivering neurostimulation to a subject (eg. Gozani, Para. 49-51, 78, 88).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL J LAU whose telephone number is (571)272-2317. The examiner can normally be reached 8-5:30 PM.
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/MICHAEL J LAU/ Examiner, Art Unit 3796
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