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 § 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 1-3, 5-9, 12-18 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lyster et al. (US 20030055478 A1).
As to claim 1, Lyster et al. discloses an evaluating method for a useful lifespan of a conductive gel, applied to a non-implantable electrical stimulation device, wherein the non-implantable electrical stimulation device comprises an electrical stimulator and an electrode assembly, the electrical stimulator is detachably electrically connected to the electrode assembly (Figures 27-31), and the evaluating method for the useful lifespan of the conductive gel (Abstract) comprises: generating a first measuring signal, wherein the first measuring signal flows through a conductive area to generate a first signal to be tested ([0185]); receiving the first signal to be tested ([0165-0171, 0200-202, 0220]); obtaining a first total impedance value according to the first signal to be tested ([0200-0205, 0220]); and obtaining the impedance value of the conductive gel according to the first total impedance value ([0254-0255]), so as to determine a useful lifespan of the conductive gel (Abstract, Figures 27-31).
As to claim 2, Lyster et al. discloses the step of obtaining the impedance value of the conductive gel according to the first total impedance value, so as to determine the useful lifespan of the conductive gel (Abstract, Figures 27-31), comprises: deducting an impedance value of the electrical stimulator, an impedance value of the electrode assembly excluding the conductive gel and a predetermined tissue impedance value from the first total impedance value, so as to obtain the impedance value of the conductive gel and determine the useful lifespan of the conductive gel ([0200-0214]).
As to claim 3, Lyster et al. discloses the impedance value of the electrical stimulator and the impedance value of the electrode assembly excluding the conductive gel are ignored, and the impedance value of the conductive gel is the first total impedance value deducting the predetermined tissue impedance value ([0127, 0140-0142, 0165-0169]).
As to claim 5, Lyster et al. discloses obtaining the impedance value of the conductive gel according to the first total impedance value, so as to determine the useful lifespan of the conductive gel (Abstract, Figures 27-31), comprises: deducting an impedance value of the electrical stimulator and an impedance value of the electrode assembly excluding the conductive gel from the first total impedance value, so as to obtain a sum of the impedance value of the conductive gel and a tissue impedance value and determine the useful lifespan of the conductive gel according to the sum of the impedance value of the conductive gel and the tissue impedance value ([0200-0214]).
As to claim 6, Lyster et al. discloses the impedance value of the electrical stimulator and the impedance value of the electrode assembly excluding the conductive gel are ignored, and the sum of the impedance value of the conductive gel and the tissue impedance value is the first total impedance value ([0127, 0140-0142, 0165-0169]).
As to claim 7, Lyster et al. discloses when the sum of the impedance value of the conductive gel and the tissue impedance value is greater than or equal to 1000 to 2000 ohms ([0140-0141]), it is determined that the useful lifespan of the conductive gel is unusable ([0148-0149, 0152-0153]).
As to claim 8, Lyster et al. discloses the non-implantable electrical stimulation device further comprises a storage box (Figure 30; [0259-0262]), the storage box comprises an upper cover and a lower cover, the upper cover and the lower cover form an accommodating space, and the accommodating space is configured to accommodate the electrical stimulator and the electrode assembly (Figure 30; [0259-0262]); wherein the lower cover comprises a conductive component and an isolation component, wherein the conductive area is the conductive component, the conductive component is disposed on the lower cover, and the isolation component is disposed on a part of the conductive component (Figure 30; [0259-0262]); wherein the step of obtaining the impedance value of the conductive gel according to the first total impedance value, so as to determine the useful lifespan of the conductive gel (Abstract, Figures 27-31), comprises: deducting an impedance value of the electrical stimulator, an impedance value of the electrode assembly excluding the conductive gel and an impedance value of the conductive component from the first total impedance, so as to obtain the impedance value of the conductive gel and determine the useful lifespan of the conductive gel ([0200-0214]).
As to claim 9, Lyster et al. discloses the impedance value of the electrical stimulator and the impedance value of the electrode assembly excluding the conductive gel are ignored, and the impedance value of the conductive gel is the first total impedance value deducting the impedance value of the conductive component ([0127, 0140-0142, 0165-0169]).
As to claim 12, Lyster et al. discloses a non-implantable electrical stimulation device (Figures 27 and 31), comprising: an electrode assembly (Abstract; depicted as 2794 in Figure 27 and 3094 in Figure 30), comprising a conductive gel ([0099-0109]); and an electrical stimulator ([0261]; Figures 27 and 31), wherein the electrical stimulator is detachably electrically connected to the electrode assembly and the electrical stimulator (Figures 27 and 30-31) comprises: an electrical stimulation signal generating circuit (Figures 27 and 31), configured to generate a first measuring signal, and the first measuring signal flows through a conductive area to generate a first signal to be tested ([0185]); and a control unit ([0261]; Figure 27 and 31), configured to receive the first signal to be tested, obtain a first total impedance value according to the first signal to be tested, and obtain the impedance value of the conductive gel according to the first total impedance value ([0254-0255]), so as to evaluate a useful lifespan of the conductive gel (Abstract, Figures 27-31).
As to claim 13, Lyster et al. discloses wherein the electrical stimulator further comprises a storage unit (memory, depicted as 2730 in Figure 27; [0235, 0240-0241, 0255]) for storing an impedance value of the electrical stimulator ([0255]), an impedance value of the electrode assembly excluding the conductive gel and a predetermined tissue impedance value ([0200-0214]); wherein the control unit deducts the impedance value of the electrical stimulator, the impedance value of the electrode assembly excluding the conductive gel and the predetermined tissue impedance value from the first total impedance value, so as to obtain the impedance value of the conductive gel and determine the useful lifespan of the conductive gel ([0200-0214, 0254-0255]).
As to claim 14, Lyster et al. discloses a storage unit (memory, depicted as 2730 in Figure 27; [0235, 0240-0241, 0255]) for storing an impedance value of the electrical stimulator ([0255]) and an impedance value of the electrode assembly excluding the conductive gel ([0099-0109]); wherein the control unit deducts the impedance value of the electrical stimulator and the impedance value of the electrode assembly excluding the conductive gel from the first total impedance value ([0200-0214, 0254-0255]), so as to obtain a sum of the impedance value of the conductive gel and a tissue impedance value ([0127, 0140-0142, 0165-0169]), and determine the useful lifespan of the conductive gel according to the sum of the impedance value of the conductive gel and the tissue impedance value ([0200-0214]).
As to claim 15, Lyster et al. discloses the conductive gel comprises a first sub conductive gel (conductive gel of first electrode, depicted as 1210 in Figure 14B) and a second sub conductive gel (conductive gel of the second electrode, also depicted as 1210 in Figure 14B); wherein the electrode assembly further comprises a conductive component and four electrical connectors (lead wires, depicted as 1740 and 1780 in Figure 17; Since there are two lead wires per electrode, as seen in Figure 17, the embodiment with two electrodes would thus have 4 wires total), wherein the conductive component (Figure 14B) comprises a first sub conductive component (foil layer of first electrode, depicted as 1220 in Figure 14B) and a second sub conductive component (foil layer of second electrode, also depicted as 1220 in Figure 14B), two of the four electrical connectors penetrate through the first sub conductive component and are electrically connected to the first sub conductive gel (Figure 17), and the other two of the electrical connectors penetrate through the second sub conductive component and are electrically connected to the second sub conductive gel (Figure 17); wherein the electrical stimulation signal generating circuit further generate a second measuring signal ([0184-0185]; impedance determining signal) and a third measuring signal ([0186-0188]; sonomicrometer signal), and the second measuring signal and the third measuring signal respectively flow through one of the two of the four electrical connectors (Figure 17), one of the other two of the four electrical connectors, the first sub conductive gel and the second sub conductive gel, so as to generate a second signal to be tested ([0184-0185]) and a third signal to be tested ([0186-0188]); wherein the control unit further respectively receives the second signal to be tested ([0184-0185], Figure 17) and the third signal to be tested through the other one of the two of the four electrical connectors and the other one of the other two of the four electrical connectors ([0186-0188]; Figure 17), obtains a second total impedance value and a third total impedance value according to the second signal to be tested and the third signal to be tested, and obtains an impedance value of the first sub conductive gel and an impedance value of the second sub conductive gel according to the second total impedance value and the third total impedance value ([0181-0187]).
As to claim 16, Lyster et al. discloses each of the first sub conductive component and the second sub conductive component includes a first portion (Conductive foil, depicted as 1720 in Figure 17) and a second portion (sonomicrometer, depicted as 1770 in Figure 17) that are separated (Figure 17), the one of the two of the four electrical connectors penetrates through the first portion of the first sub conductive component and is electrically connected to the first sub conductive gel (Figure 17), the other one of the two of the four electrical connectors penetrates through the second portion of the first sub conductive component and is electrically connected to the first sub conductive gel (Figure 17), the one of the other two of the four electrical connectors penetrates through the first portion of the second sub conductive component and is electrically connected to the second sub conductive gel (Figure 17),and the other one of the other two of the four electrical connectors penetrates through the second portion of the second sub conductive component and is electrically connected to the second sub conductive gel (Figure 17).
As to claim 17, Lyster et al. discloses the electrical stimulator further comprises a storage unit (memory, depicted as 2730 in Figure 27; [0235, 0240-0241, 0255]) for storing an impedance value of the electrical stimulator ([0255]) and an impedance value of the electrode assembly excluding the conductive gel ([0099-0109]); wherein the control unit deducts the impedance value of the electrical stimulator and the impedance value of the electrode assembly excluding the conductive gel from the second total impedance value ([0200-0214, 0254-0255]), so as to obtain the impedance value of the first sub conductive gel, and deducts the impedance value of the electrical stimulator and the impedance value of the electrode assembly excluding the conductive gel from the third total impedance value ([0127, 0140-0142, 0165-0169]), so as to obtain the impedance value of the second sub conductive gel ([0200-0214]).
As to claim 18, Lyster et al. discloses the non-implantable electrical stimulation device further comprises a storage box (Figure 30; [0259-0262]), wherein the storage box comprises an upper cover and a lower cover, the upper cover and the lower cover form an accommodating space, and the accommodating space is configured to accommodate the electrical stimulator and the electrode assembly (Figure 30; [0259-0262]); wherein the lower cover comprises a conductive component and an isolation component, wherein the conductive area is the conductive component, the conductive component is disposed on the lower cover, and the isolation component is disposed on a part of the conductive component (Figure 30; [0259-0262]); wherein the electrical stimulator further comprises a storage unit (memory, depicted as 2730 in Figure 27; [0235, 0240-0241, 0255]) for storing an impedance value of the electrical stimulator ([0255]), an impedance value of the electrode assembly excluding the conductive gel ([0099-0109]) and an impedance value of the conductive component ([0200-0214, 0254-0255]); wherein the control unit deducts the impedance value of the electrical stimulator, the impedance value of the electrode assembly excluding the conductive gel and the impedance value of the conductive component from the first total impedance value ([0200-0214, 0254-0255]), so as to obtain the impedance value of the conductive gel and determine the useful lifespan of the conductive gel ([0200-0214]).
As to claim 20, Lyster et al. discloses the electrical stimulator further comprises a warning unit ([0247-0262]); wherein the control unit is further configured to generate a warning signal to the warning unit according to the impedance value of the conductive gel and a predetermined impedance value, so that the warning unit displays the warning signal ([0241-0252]; Figures 27-31).
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, 10-11 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Lyster et al. (US 20030055478 A1).
As to claim 4, Lyster et al. discloses determining useful lifespan of the conductive gel and assessing if a conductive gel is unusable based on exceeding a threshold ([0117, 0247-0249]) but does not explicitly disclose the threshold is an impedance value for the conductive gel is greater than or equal 600 to 800 ohms. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the threshold range od Lyster et al., 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 (see MPEP 2144.05). Furthermore, such a modification would provide the predictable results of ensuring sufficient operational parameters.
As to claims 10 and 19, Lyster et al. discloses a non-implantable electrical stimulation device further comprises a storage box (Figure 30; [0259-0262]), the storage box comprises an upper cover and a lower cover, the upper cover and the lower cover form an accommodating space, and the accommodating space is configured to accommodate the electrical stimulator and the electrode assembly storage box (Figure 30; [0259-0262]) and determination of the useful lifespan of the conductive gel (Abstract, Figures 27-31), comprises: deducting an impedance value of the electrical stimulator, an impedance value of the electrode assembly excluding the conductive gel and an impedance value of the impedance component from the first total impedance, so as to obtain the impedance value of the conductive gel and determine the useful lifespan of the conductive gel ([0200-0214]). Lyster et al. additionally discloses a circuit board and an isolation component, wherein the conductive area is the circuit board that comprises a first metal trace, a second metal trace and an impedance component, the impedance component is connected between the first metal trace and the second metal trace, and the isolation component is disposed on the circuit board and exposes the first metal trace and the second metal trace (Figures 27-31; [0258-0262]).
Thus, Lyster et al. discloses the circuit board and isolation component in the upper cover ([0261]; Figure 30) but does not explicitly disclose the option of placing the circuit board and isolation component are located in the lower cover. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the location of circuit board and isolation component from the upper cover to the lower cover, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70 (see MPEP 2144.04).
As to claim 11, the modified Lyster et al. discloses the impedance value of the electrical stimulator and the impedance value of the electrode assembly excluding the conductive gel are ignored, and the impedance value of the conductive gel is the first total impedance value deducting the impedance value of the impedance component ([0127, 0140-0142, 0165-0169]).
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ALYSSA M ALTER/Primary Examiner, Art Unit 3796