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 Group I, claims 1-8 in the reply filed on 6/26/2026 is acknowledged.
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, 3, 4, and 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.
Claim 1 recites the limitation "the electrode" in line 4. There is insufficient antecedent basis for this limitation in the claim. “An electrode lead” was claimed in line 3 but no “electrode” has been introduced/claimed yet in claim 1. For purposes of examination, the phrase is being interpreted as “an electrode”.
The term “about” in claims 3, 4, and 8 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Applicant should either remove the term “about” or more clearly define the phrase in claims 3, 4, and 8. For purposes of examination, the examiner is interpreting the claims as if the word “about” is not in the claims.
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.
Claim(s) 1, 6, and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Greenberg et al. (Pub. No.: US 2007/0255319 A1); hereinafter referred to as “Greenberg”, in view of Dufresne et al. (Patent Number: 4,917,093); hereinafter referred to as “Dufresne”.
Regarding claim 1, Greenberg discloses a method for more safely monitoring (e.g. see [0002], “an improved method of providing safety checks to prevent neural damage”) a direct current electrode system (e.g. see [0027], “The integrated circuit includes an excessive direct current flow (EDCF) detection circuit as shown in FIG. 2. In the implant or saline environment, a certain amount of continuous DC current passing through an electrode array will cause bubbling which may result in damage to neural tissue. The EDCF circuit detects harmful DC leakage levels and transmits this information through the inductive coil 16 to the external electronics”), comprising: delivering direct current via an electrode lead to a target tissue of a patient (e.g. see [0027], “The electronics package 14 includes an integrated circuit for controlling stimulation. The integrated circuit includes an excessive direct current flow (EDCF) detection circuit as shown in FIG. 2”); measuring the driving voltage across the electrode (e.g. see [0028], “Electrode bubbling occurs when the voltage across the double layer of the electrode-tissue interface exceeds a threshold voltage window over certain time duration during the stimulation cycles. This threshold voltage window is found to be around +/-1.5V for a flexible circuit electrode array 10”), comparing the driving voltage across the electrode to predetermined threshold range values (e.g. see claim 21 of Greenberg, “a comparator comparing voltage on said common line to a predetermined reference voltage”, [0027], “A comparator 212 detects the potential against a predetermined middle potential. The output of the comparator 212 is captured after a predetermined interval, preferably 250 microseconds, which is then interpreted by EDCF control logic”, and [0028] discloses “Electrode bubbling occurs when the voltage across the double layer of the electrode-tissue interface exceeds a threshold voltage window over certain time duration during the stimulation cycles. This threshold voltage window is found to be around +/-1.5V for a flexible circuit electrode array 10”).
Greenberg discloses the invention but is silent as to measuring the body impedance; determining a voltage drop across the lead from the body impedance measurement; and adjusting the driving voltage to maintain the voltage drop across the lead within a predetermined voltage range. Dufresne teaches measuring the body impedance (e.g. see column 4 lines 61-66, “The load for the output stage 16 is determined primarily from the electrode-biological tissue interface impedance, which is essentially the impedance at the point of contact between electrode elements 20 and 22 with the biological tissue, and the impedance of the biological tissue between electrode elements 20 and 22”); determining a voltage drop across the lead from the body impedance measurement (e.g. see column 5 lines 29-30 and 39, “actual voltage drop across the load impedance”); and adjusting the driving voltage to maintain the voltage drop across the lead within a predetermined voltage range (e.g. see column 3 lines 29-36, “An adjustment circuit is coupled to the output circuit and to the high voltage power supply for comparing the amplitude of the high voltage signal to the amplitude of the voltage drop across the biological load and then adjusting the amplitude of the high voltage signal dependent upon the result of the comparing”) to determine whether there is excess high voltage signal available and, hence, whether energy from the battery is being wasted (e.g. see column 5 lines 30-32). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use the circuitry configuration as taught by Dufresne in the system/method of Greenberg, since said modification would provide the predictable results of determining whether there is excess high voltage signal available and, hence, whether energy from the battery is being wasted.
Regarding claim 6, Greenberg discloses adjusting the amplitude (e.g. see [0042], [0047]) but is silent as to adjusting the driving voltage comprises adjusting the amplitude of direct current delivered. Dufresne teaches it is known to use such a modification as set forth in column 3 lines 63-68, column 4 lines 1-2 to provide to minimize the amplitude of the high voltage signal and still have sufficient voltage amplitude to allow the output circuit to produce the electrical stimulation signal at a predetermined current amplitude (e.g. see column 3 lines 63-68, column 4 lines 1-2). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use the circuitry configuration as taught by Dufresne in the system/method of Greenberg, since said modification would provide the predictable results of minimizing the amplitude of the high voltage signal and still have sufficient voltage amplitude to allow the output circuit to produce the electrical stimulation signal at a predetermined current amplitude.
Regarding claim 7, Greenberg discloses the direct current comprises cathodic direct current cycled with anodic direct current (e.g. see [0042], [0047]).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Greenberg and Dufresne as applied to claim 1 above, and further in view of Vaingast et al. (Pub. No.: 2006/0265027 A1); hereinafter referred to as “Vaingast”.
Regarding claim 2, Greenberg and Dufresne disclose the invention but are silent as to measuring the body impedance comprises delivering a short circuit current input across the electrode lead. Vaingast teaches it is known to use such a modification as set forth in [0013], [0016] to reduce and even eliminate electrolysis effects at the electrodes and more precisely define the tissue stimulation level (e.g. see [0013]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use the circuit configuration as taught by Vaingast in the system/method of Greenberg and Dufresne, since said modification would provide the predictable results of reducing and even eliminating electrolysis effects at the electrodes and more precisely defining the tissue stimulation level.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Greenberg, Dufresne, and Vaingast as applied to claims 1 and 2 above, and further in view of Keen (Pub. No.: US 2002/0015963 A1).
Regarding claim 3, Greenberg, Dufresne, and Vaingast disclose the invention but are silent as to the short circuit current input is about or less than about 100 microamps. Keen teaches it is known to use such a modification as set forth in [0216], lower curve of figure 7, to provide current input at a lower, safer amplitude. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use the short circuit current input is about or less than about 100 microamps as taught by Keen in the system/method of Greenberg, Dufresne, and Vaingast, since said modification would provide the predictable results of a current input at a lower, safer amplitude.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Greenberg, Dufresne, and Vaingast as applied to claims 1 and 2 above, and further in view of Manne (Pub. No.: US 2004/0181261 A1).
Regarding claim 4, Greenberg, Dufresne, and Vaingast disclose the invention but are silent as to the short circuit current input is delivered for less than about 200 microseconds. Manne teaches it is known to use such a modification as set forth in [0173]-[0174] to provide more brief stimulation which impacts the patient less. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use the short circuit current input is delivered for less than about 200 microseconds as taught by Manne in the system/method of Greenberg, Dufresne, and Vaingast, since said modification would provide the predictable results of more brief stimulation which impacts the patient less.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Greenberg and Dufresne as applied to claim 1 above, and further in view of Blauw et al. (Pub. No.: US 2011/0192720 A1); hereinafter referred to as “Blauw”.
Regarding claim 5, Greenberg and Dufresne disclose the invention but are silent as to the predetermined voltage range is below the electrolysis potential of water. Blauw teaches it is known to use such a modification as set forth in [0059] to provide a reference electrode with a good lifetime and a good response time (e.g. see [0014]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use the predetermined voltage range is below the electrolysis potential of water as taught by Blauw in the system/method of Greenberg and Dufresne, since said modification would provide the predictable results of a reference electrode with a good lifetime and a good response time.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Greenberg and Dufresne as applied to claim 1 above, and further in view of Palermo et al. (Pub. No.: US 2008/0208287 A1); hereinafter referred to as “Palermo”.
Regarding claim 8, Greenberg and Dufresne disclose the invention but are silent as the direct current comprises a frequency of less than about 1 Hz. Palermo teaches it is known to use such a modification as set forth in [0150] to provide different burst frequencies so as to generate the simultaneous production of endorphins, dynorphins, enkephalin, and serotonin during each of the respective sequences, which is believed to have beneficial effects in the treatment of neurological disorders due to the normalization of hyperactive sensory inputs (which play a role in the re-education of the central pattern generators) or triggering descending inhibition to reduce overactive muscle tone and/or spasticity (e.g. see [0022]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use the direct current comprises a frequency of less than about 1 Hz as taught by Palermo in the system/method of Greenberg and Dufresne, since said modification would provide the predictable results of different burst frequencies so as to generate the simultaneous production of endorphins, dynorphins, enkephalin, and serotonin during each of the respective sequences, which is believed to have beneficial effects in the treatment of neurological disorders due to the normalization of hyperactive sensory inputs (which play a role in the re-education of the central pattern generators) or triggering descending inhibition to reduce overactive muscle tone and/or spasticity.
Conclusion
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/P.C.E/Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792
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