DETAILED ACTION
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 1-38, drawn to an implantable device for tissue stimulation.
Group II, claim(s) 39-62, drawn to a method of applying current to a tissue of a subject.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I and II lack unity of invention because even though the inventions of these groups require the technical feature of routing received electrical energy to different electrodes at different locations inside the body, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Glukhovsky et al. (Pub. No.: US 2014/0172053 A1); hereinafter referred to as “Glukhovsky”. Per the 102 rejection below for claim 1, Glukhovsky discloses the special technical feature of routing received electrical energy to different electrodes at different locations inside the body.
During a telephone conversation with Kristen Hansen on 5/18/2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-38. Affirmation of this election must be made by applicant in replying to this Office action. Claims 39-62 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
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 16, 32, and 36 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 16 recites the limitations “the first location” and “the second location” in lines 7 and 8, respectively. There is insufficient antecedent basis for this limitation in the claim.
Claim 32 recites the limitation “the second end” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 36 recites the limitation “the carrier frequency” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-11, 15-34, and 36-38 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Glukhovsky et al. (Pub. No.: US 2014/0172053 A1); hereinafter referred to as “Glukhovsky”.
Regarding claim 1, Glukhovsky discloses an implantable device (e.g. see [0120]-[0121]) comprising: a receiving electrode (e.g. see figure 9A element 30, [0142]-[0146]); a first output electrode (e.g. see figure 9A element 12a, [0142]); a first channel (e.g. see figure 9A element 24a, [0142]-[0144]), the implantable device being configured to receive a transcutaneous current (e.g. see figure 9A element 30, [0142]-[0146]) having a first portion and a second portion (e.g. see [0017], [0033], [0061]-[0064]. Note: Alternating current will have different portions), the first channel being configured to allow the first portion of the transcutaneous current to pass from the receiving electrode to the first output electrode (e.g. see figure 9A element 24a, [0142]-[0144]) and to inhibit the second portion of the transcutaneous current passing from the first output electrode to the receiving electrode (e.g. see [0158]. The insulation of the three channels will inhibit current); a second output electrode (e.g. see figure 9A element 12b, [0142]); and a second channel (e.g. see figure 9A element 24b, [0142]-[0144]) configured to allow the second portion of the transcutaneous current to pass from the second output electrode to the receiving electrode (e.g. see figure 9A element 24b, [0142]-[0144]) and to inhibit the first portion of the transcutaneous current passing from the receiving electrode to the second output electrode (e.g. see [0158]. The insulation of the three channels will inhibit current).
Regarding claim 2, Glukhovsky discloses the transcutaneous current is an alternating transcutaneous current, the first portion of the transcutaneous current is a positive portion of the alternating transcutaneous current, and the second portion of the transcutaneous current is a negative portion of the alternating transcutaneous current (e.g. see [0017], [0033], [0061]-[0064]).
Regarding claim 3, Glukhovsky discloses the transcutaneous current comprises a series of bursts of alternating transcutaneous current, the first portion of the transcutaneous current is a positive portion of the series of bursts of alternating transcutaneous current, and the second portion of the transcutaneous current is a negative portion of the series of bursts of alternating transcutaneous current (e.g. see [0017], [0033], [0061]-[0064]).
Regarding claim 4, Glukhovsky discloses the implantable device is configured to receive the transcutaneous current from an external generator (e.g. see figure 9A elements 50, 20, 22, [0139]-[0146]).
Regarding claim 5, Glukhovsky discloses the transcutaneous current received by the implantable device is a fraction of a current applied by the external generator (e.g. see figure 9A elements 50, 20, 22, [0139]-[0146]).
Regarding claim 6, Glukhovsky discloses the implantable device is configured to receive transcutaneous current from an external generator through electrically conductive coupling (e.g. see figure 9A elements 50, 20, 22, [0139]-[0146]).
Regarding claim 7, Glukhovsky discloses the electrically conductive coupling is electrically coupling through conductive body tissue (e.g. see figures 2-6, element 10).
Regarding claim 8, Glukhovsky discloses the implantable device is configured to: receive a burst of alternating transcutaneous current from an external generator (e.g. see [0017], [0033], [0061]-[0064]), the burst of alternating transcutaneous current burst having a positive portion and a negative portion (e.g. see figure 9a elements 20, 22 [0142]); rectify the burst of alternating transcutaneous current to generate a positive current burst (e.g. see [0133]); rectify the burst of alternating transcutaneous current to generate a negative current burst (e.g. see [0133]); stimulate tissue at an implantation site of the first output electrode utilizing the positive current burst (e.g. see [0142]); and stimulate tissue at an implantation site of the second output electrode using the negative current burst (e.g. see [0142]).
Regarding claim 9, Glukhovsky discloses the implantable device is configured to: receive a high frequency (e.g. see [0133]) transcutaneous current from an external generator (e.g. see figure 9A elements 50, 20, 22, [0139]-[0146]), the high frequency transcutaneous current burst having a positive portion and a negative portion (e.g. see figure 9a elements 20, 22 [0142]); rectify the high frequency transcutaneous current to generate a positive high frequency current (e.g. see [0133]); rectify the high frequency transcutaneous current to generate a negative high frequency current (e.g. see [0133]); stimulate tissue at an implantation site of the first output electrode utilizing the positive high frequency current (e.g. see [0142]); and stimulate tissue at an implantation site of the second output electrode using the negative high frequency current (e.g. see [0142]).
Regarding claim 10, Glukhovsky discloses the first channel comprises a first rectification element configured to inhibit current from flowing from the first output electrode to the receiving electrode (e.g. see [0158]. The insulation of the three channels will inhibit current).
Regarding claim 11, Glukhovsky discloses the second channel comprises a second rectification element configured to inhibit current from flowing from the receiving electrode to the second output electrode (e.g. see [0158]. The insulation of the three channels will inhibit current).
Regarding claim 15, Glukhovsky discloses the first output electrode and the second output electrode are configured to be implanted in proximity to a nerve of a subject (e.g. see figure 10A elements 12 and 70), and wherein the receiving electrode is configured to be implanted in proximity to a surface of the skin of the subject (e.g. see figure 10A elements 12 and 70).
Regarding claim 16, Glukhovsky discloses the implantable device is configured to apply monopolar stimulation (e.g. see [0122]) to the nerve at an implantation site of the first output electrode, is configured to apply monopolar stimulation to the nerve at an implantation site of the second output electrode (e.g. see [0122]), and is configured to apply quasi-bipolar stimulation to the nerve between the implantation site of the first output electrode and the implantation site of the second output based on applying monopolar stimulation to the tissue at the first location and applying monopolar stimulation at the second location (e.g. see [0122]).
Regarding claim 17, Glukhovsky discloses a bypass electrode; and a bypass channel configured to allow transcutaneous current to pass between the receiving electrode and the bypass electrode, wherein the bypass channel is configured to allow current to pass from the receiving electrode to the bypass electrode and to pass from the bypass electrode to the receiving electrode (e.g. see figure 12e elements 70a and 70b).
Regarding claim 18, Glukhovsky discloses the first output electrode and the second output electrode are between the receiving electrode and the bypass electrode, and wherein the implantable device is configured to stimulate an efferent nerve (e.g. see figure 12e elements 70a and 70b).
Regarding claim 19, Glukhovsky discloses the bypass electrode is between the receiving electrode and the first output electrode, and wherein the implantable device is configured to stimulate an afferent nerve (e.g. see figure 12e elements 70a and 70b).
Regarding claim 20, Glukhovsky discloses the bypass electrode is between the receiving electrode and the first output electrode, and wherein the implantable device is configured to stimulate a nerve containing both efferent and afferent fibers (e.g. see figure 12e elements 70a and 70b).
Regarding claim 21, Glukhovsky discloses the bypass channel is configured to deliver alternating transcutaneous current (e.g. see [0017], [0033], [0061]-[0064]) to inhibit activation of the nerve (e.g. see claims 4 and 26).
Regarding claim 22, Glukhovsky discloses the bypass channel is configured to deliver low frequency current for nerve stimulation (e.g. see [0133], “The external stimulator 50 delivers a sub-threshold signal, which can be, for example, a sinusoidal signal having a frequency outside those of the ENG, to the surface cathodic electrode 20 which delivers the electrical current to termination 30”), and the first channel is configured to deliver rectified alternating current for nerve stimulation (e.g. see [0133]).
Regarding claim 23, Glukhovsky discloses the bypass channel comprises a tuning resistor configured to determine the ratio of current applied by the bypass channel relative to the first channel (e.g. see [0133]. The examiner is interpreting the digital amplifier 46 as the tuning resistor).
Regarding claim 24, Glukhovsky discloses an implantable lead (e.g. see figure 10 element 66, [0155]-[0157]), wherein: the implantable lead comprises a first end and a second end opposite the first end, the receiving electrode is located at or near the first end of the implantable lead (e.g. see figure 10 element 68, p1-p3), and the first output electrode or the second output electrode is located at or near the second end of the implantable lead (e.g. see figure 10 element 70, e1-e3).
Regarding claim 25, Glukhovsky discloses the first output electrode and the second output electrode are located at or near the second end of the implantable lead (e.g. see figure 10 element 70, e1-e3).
Regarding claim 26, Glukhovsky discloses an implantable lead, wherein: the implantable lead comprises a first end (e.g. see figure 9A element 12a), a first branch (e.g. see figure 9A element 24b) with a second end (e.g. see figure 9A element 12b), and a second branch (e.g. see figure 9A element 24c) with a third end (e.g. see figure 9A element 12c), the receiving electrode (e.g. see figure 9A element 30) is located at or near the first end of the implantable lead, the first output electrode is located at or near the second end of the implantable lead (e.g. see figure 9A element 12b), and the second output electrode is located at or near the third end of the implantable lead (e.g. see figure 9A element 12c).
Regarding claim 27, Glukhovsky discloses a receiver (e.g. see figure 5 element 30), wherein: the receiver comprises a cavity (e.g. see figure 5 element 30. Note: Element 30 is between the skin 10 and the nerve 12, and thus “comprises a cavity”), the first channel comprises a rectification element (e.g. see [0133], figure 5 element 52) configured to rectify current flowing in the first channel, and the rectification element is in the cavity of the receiver (e.g. see [0133], figure 5 element 52).
Regarding claim 28, Glukhovsky discloses the second channel comprises a second rectification element (e.g. see [0133], figure 5 element 52) configured to rectify current flowing in the second channel, the second rectification element being in the cavity of the receiver (e.g. see figure 5 element 30. Note: Element 30 is between the skin 10 and the nerve 12, and thus “comprises a cavity”).
Regarding claim 29, Glukhovsky discloses the receiver further comprises a lead connector (e.g. see figure 5 element 24).
Regarding claim 30, Glukhovsky discloses a receiver (e.g. see figure 5 element 48), the receiver comprising the receiving electrode (e.g. see figure 5 element 30) and a cavity (e.g. see figure 5 element 48. Note: Element 48 is between the skin 10 and the nerve 12, and thus “comprises a cavity”), and electrical elements configured to rectify (e.g. see [0133], figure 5 element 52) the electrical current flowing in the first or in the second channel, the electrical elements being in the cavity of the receiver (e.g. see figure 5 element 48).
Regarding claim 31, Glukhovsky discloses the receiver (e.g. see figure 5 element 48) comprises an electrical (e.g. see figure 5 element 24) and mechanical connector (e.g. see figure 9a element 67) configured to attach and electrically connect to a first end of an implanted lead.
Regarding claim 32, Glukhovsky discloses the first end of the lead electrically connects the first and the second channels to the second end of the lead (e.g. see figure 9a, elements 24a, 24b, 24c).
Regarding claim 33, Glukhovsky discloses the transcutaneous current is a burst of alternating transcutaneous current with a carrier frequency between 5 kHz and 100 kHz (e.g. see [0133]).
Regarding claim 34, Glukhovsky discloses the transcutaneous current is a burst of alternating transcutaneous current with a carrier frequency between 100 kHz and 5 MHz (e.g. see [0133]. Note: “higher than 30-50 KHz” will include 100 kHz to 5 MHz).
Regarding claim 36, Glukhovsky discloses the transcutaneous current is a burst of alternating transcutaneous current (e.g. see [0017], [0033], [0061]-[0064]) and wherein the carrier frequency of the alternating transcutaneous current has a first value at a first time during the burst of alternating transcutaneous current and has a second value at a second time during the burst of alternating transcutaneous current, the first value being different than the second value (e.g. see [0017], [0033], [0061]-[0064]. Note: Alternating current necessarily varies as it alternates and thus has first and second values).
Regarding claim 37, Glukhovsky discloses the transcutaneous current comprises a first burst of alternating transcutaneous current and a second burst of alternating transcutaneous current (e.g. see [0017], [0033], [0061]-[0064]. Note: Alternating current necessarily varies as it alternates and can be interpreted as different “bursts”), wherein a carrier frequency of the transcutaneous current during the first burst is different than a carrier frequency of the transcutaneous current during the second burst (e.g. see [0134]).
Regarding claim 38, Glukhovsky discloses the transcutaneous current comprises a first burst of alternating transcutaneous current and a second burst of alternating transcutaneous current (e.g. see [0017], [0033], [0061]-[0064]. Note: Alternating current necessarily varies as it alternates and can be interpreted as different “bursts”), wherein a carrier waveform of the transcutaneous current during the first burst is different than a carrier waveform of the transcutaneous current during the second burst (e.g. see [0134]).
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) 12-14 and 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glukhovsky in view of Wang et al. (Patent Number: 5,702,431); hereinafter referred to as “Wang”.
Regarding claim 12, Glukhovsky discloses a rectification element (e.g. see [0133], figure 5 element 52) but is silent as to the rectification element is a diode. Wang teaches it is known to use such a modification as set forth in column 13 lines 16-19 (Note: The examiner is equating diode 115 in the prior art to the rectifying diode) to provide a charging device which can efficiently charge a battery in an implanted medical device at a relatively high power transfer rate while reducing the peak temperature generated by the device (e.g. see column 4 lines 15-20). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use a diode as the rectifying element as taught by Wang in the system of Glukhovsky, since said modification would provide the predictable results of a charging device which can efficiently charge a battery in an implanted medical device at a relatively high power transfer rate while reducing the peak temperature generated by the device.
Regarding claim 13, Glukhovsky discloses the invention but is silent as to the first channel comprises a capacitor coupled between the first output electrode and the receiving electrode, a diode coupled between the first output electrode and the receiving electrode, and a resistor coupled in parallel to the diode. Wang teaches it is known to use such a modification as set forth in column 13 lines 4-19 (Note: The examiner is equating diode 115 in the prior art to the diode in this claim and the peak storage capacitor 120 to the capacitor in this claim) to provide a charging device which can efficiently charge a battery in an implanted medical device at a relatively high power transfer rate while reducing the peak temperature generated by the device (e.g. see column 4 lines 15-20). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use the circuit as taught by Wang in the system of Glukhovsky, since said modification would provide the predictable results of a charging device which can efficiently charge a battery in an implanted medical device at a relatively high power transfer rate while reducing the peak temperature generated by the device.
Regarding claim 14, Glukhovsky discloses the invention but is silent as to the second channel comprises a second capacitor coupled between the second output electrode and the receiving electrode, a second diode coupled between the second output electrode and the receiving electrode, and a second resistor coupled in parallel to the second diode (Note: WANG discloses wherein the second channel comprises a second capacitor coupled between the second output electrode and the receiving electrode (terminal (second channel) of comparator 126 includes a capacitor 125 between output and input; column 14, lines 2-7), a second diode coupled between the second output electrode and the receiving electrode (LED 131 coupled between the output and input of comparator 126; column 14, lines 2-9), and a second resistor coupled in parallel to the second diode (a resistor 127 coupled in parallel to the LED 131; column 14, lines 2-9)). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use the circuit as taught by Wang in the system of Glukhovsky, since said modification would provide the predictable results of a charging device which can efficiently charge a battery in an implanted medical device at a relatively high power transfer rate while reducing the peak temperature generated by the device.
Regarding claim 35, Glukhovsky discloses stimulating in the 30 kHz to 50 kHz range (e.g. see [0133]) but is silent as to the transcutaneous current is a burst of alternating transcutaneous current with a carrier frequency between 1 kHz and 5 kHz. Wang teaches it is known to use such a modification as set forth in column 9 lines 25-30 to provide a charging device which can efficiently charge a battery in an implanted medical device at a relatively high power transfer rate while reducing the peak temperature generated by the device (e.g. see column 4 lines 15-20). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use the stimulation range taught by Wang in the system of Glukhovsky, since said modification would provide the predictable results of a charging device which can efficiently charge a battery in an implanted medical device at a relatively high power transfer rate while reducing the peak temperature generated by the device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILIP C EDWARDS whose telephone number is (571)270-1804. The examiner can normally be reached Mon-Fri, 9:00-5:00 EST.
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/P.C.E/Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792
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