The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
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.
Claims 1-3, 6-11, 13-20 are rejected under 35 U.S.C. 103 as being unpatentable over Giftakis et al. (US Patent Pub. No. 2006/0229686) in view of Wagenbach et al. (US Patent Pub. No. 2020/0305745).
Giftakis discloses “An assembly for sensing physiologic signals and delivering monopolar stimulation therapy” (see Abstract). Specifically, Giftakis teaches a method for providing stimulation to a patient’s brain (see paragraph 25, “The assembly depicted in FIG. 1 is a deep brain EEG sensing and stimulation system”) using a system comprising a stimulator device (see the system illustrated in Figure 1, for example), the stimulator device comprising a case (see case illustrated in Figures 3-4) and a plurality of electrodes comprising a case electrode associated with the case (see electrode 14 in Figures 3-4; see paragraphs 28-29) and other electrodes different from the case electrode (see electrode 42 in Figure 4, electrode 16 in Figure 5, electrode 28 in Figure 6B, and electrode 19 in Figure 8), the method comprising:
using stimulation circuitry within the case to provide stimulation between at least two of the plurality of electrodes (see paragraph 26, “An implantable pulse generator (IPG) 10 is implanted proximate to the patient's clavicle. The IPG 10 includes a pulse generating source”; note that in paragraph 24 it discusses that the “electrode can function as an indifferent electrode for monopolar stimulation” and paragraph 25 teaches that “Each of the monopolar stimulation assemblies described hereafter produces electrical impulses as a fully implantable system. Electrical impulses occur as current flows between an active electrode and an indifferent electrode through the body tissue”; see paragraph 27, “One aspect of the inventive monopolar stimulation assembly includes positioning the indifferent electrode away from the IPG 10 and in remote locations with respect to the electrodes 28. For this reason, the indifferent electrode will hereafter be referred to as a remote electrode”, noting that each of electrodes 14, 16, 18, 19 and 42 are all described as “remote electrodes” within the disclosure);
providing one or more first of the other electrodes within the patient’s brain (see electrode 28 in Figure 6B);
providing one or more second of the other electrodes within the patient’s head but not within the brain (see any one of electrodes 16, 18 and/or 19 within Figures 6A, 6B, 7 and 8, noting that electrode 16 is located on connector 22 and is shown in Figures 1 and 6B as being located “within the head” region of the patient); and
sensing a tissue signal in the brain using at least one of the first electrodes as a primary sensing electrode (see paragraph 25 which teaches that “The assembly depicted in FIG. 1 is a deep brain EEG sensing and stimulation system for the detection and termination of epileptic seizures”; also see paragraph 5 which teaches that “Standard diagnostic EEG sensing requires two electrodes in contact with body tissue. The first electrode is placed near the desired source of the electrical activity that the physician desires to monitor, and is referred to as active. The second electrode, referred to as the reference, is typically placed outside of the cranium away from the desired source of electrical activity”) and using at least one of the second electrodes as a sensing reference electrode (note that paragraphs 28 teaches that electrode 14 is a reference electrode; note that paragraph 39 teaches that “the remote electrode can be used as a reference electrode to sense neurological activity”, thereby teaching that each one of electrodes 16, 18 and/or 19 can be used as reference electrodes during EEG sensing).
It is noted that Giftakis a case electrode associated with the case (see electrode 14 in Figures 3-4; see paragraphs 28-29), this “remote electrode 14 is positioned on the header block 12 instead of the IPG 10”. Although Giftakis does state that “conventional monopolar stimulation assemblies utilize a conductive area of the IPG housing as a remote electrode” (see paragraph 32).
Wagenbach teaches that “Implantable neurostimulator devices are devices that generate and deliver electrical stimuli to body nerves and tissues for the therapy of various biological disorders, such as … cortical and deep brain stimulators to treat motor and psychological disorders… present invention may find applicability with any implantable neurostimulator device system” (see paragraph 3). As taught in paragraph 9, “IPG 10 as mentioned includes stimulation circuitry 28 to form prescribed stimulation at a patient's tissue… The stimulation circuitry 28 in this example also supports selection of the conductive case 12 as an electrode (Ec 12), which case electrode is typically selected for monopolar stimulation.”
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to use a conductive area of the IPG housing itself as the remote electrode, as hinted at in Giftakis within paragraph 32, and as explicitly taught within the system and methods of Wagenbach, because Giftakis teaches that this can be done with some IPGs, while Wagenbach explicitly teaches to do this in a working example. As such a modification amounts to substitution of known equivalents for providing a remote/reference electrode at the location of the IPG to yield predictable results (KSR v. Teleflex).
Regarding claim 2, Figure 1 and 6B illustrate the IPG located within the torso of the patient. Also, paragraph 26 teaches “An implantable pulse generator (IPG) 10 is implanted proximate to the patient's clavicle.”
Regarding claim 3, paragraph 5 teaches that “In a monitoring system or device, differential amplifiers measure the voltage difference between the reference electrode and other active electrodes located within the brain. The resulting intracranial signals are amplified and displayed as channels of EEG activity.” In paragraph 33, Giftakis teaches “the lead extension 20 provides an electrical connection from the remote electrode 16 back to the EEG sensing circuitry, or other circuitry coupled to the pulse generating circuitry, within the IPG 10”, which makes it clear that the IPG contains EEG sensing circuitry. Therefore, the IPG’s EEG sensing circuitry contains the stated differential amplifiers that measure the voltage difference between the reference electrode and other active electrodes located within the brain, and this means that the signals from electrode 28 within the brain would be connected to one input of the differential amplifier while signals from electrode 16 (as explicitly stated in the quote from paragraph 33) would therefore be used as input into a second input of the differential amplifier, based on the teachings of paragraph 5.
Regarding claim 6, Giftakis teaches that “conventional monopolar stimulation assemblies utilize a conductive area of the IPG housing as a remote electrode”.
Regarding claim 7, Figure 6B illustrates the system implanted within a patient, in which reference/remote electrodes 16, 18 and 19 (i.e., the one of more second electrodes) are all part of the same lead 20,23 as that of electrode 28 (i.e., the one or more first electrodes).
Regarding claim 8, Figure 6B illustrates that electrode 16, which is found on connector 22, is more proximate to the case the electrode(s) 28.
Regarding claim 9, it is noted that the title of Giftakis is “monopolar stimulation assembly including at least one remote electrode”. Therefore, the teachings of Giftakis include an embodiment in which there is one remote electrode, as well as the possibility of more than one remote electrode.
Regarding claim 10, it can be seen that connector 22, which comprises remote electrode 16 is shown in Figure 6B as being displaced from any point of electrodes 28 by more than twice the length of electrode 28. Additionally, Figure 1 illustrates the connector 22 displaced from electrode 28 by approximately the length of electrodes 28. Since the length of 28 shown in the figures comprises multiple electrodes thereon within that length, the distance described in the previous two sentences is clearly more than the distance of separation of the individual electrodes 28 from one another along the length labeled as 28 in these figures.
Regarding claim 11, it is noted that electrodes 28 are configured to be the active electrodes, while electrodes 14, 16, 18, 19 and 42 are all described as being remote/reference electrodes. Therefore, they are differently configured.
Regarding claim 13, Giftakis states that “FIG. 8 is a detailed cross sectional view of a ring 30 and a cap 32, together securing the two intracranial leads 23, 25 while also closing off a burr hole 24… The cap 32 is then installed to engage the burr ring 30, and thereby further close off the aperture 38” (see paragraph 36).
Regarding claims 14-15, Giftakis teaches that “in the arrangement illustrated in FIG. 7 a remote electrode 18 is attached to, or imbedded into the cap 32. A wire 25a or other conductive element attaches the remote electrode 18 to a set screw 38 that is threaded into the cap 32. The set screw 38 is just one exemplary device that functions to secure the intracranial lead 25, and also to establish an electrical connection between the remote electrode 18 and the intracranial lead 25” (see paragraph 37-38).
Regarding claim 16, Giftakis teaches in paragraph 38 that “FIG. 8 illustrates another way to use the ring 30 and cap 32 to position a remote electrode on or near the brain. In this embodiment, the ring 30 extends entirely through the burr hole 24, and the lower edge of the ring that is closest to the dura mater covering the brain functions as a remote electrode 19.”
Regarding claim 17, Wagenbach teaches “to sense a neural response to the stimulation at a sensing electrode node” (see paragraphs 17-18). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to sense the neural response in the system and methods of Giftakis, as is taught by Wagenbach, in order to provide Giftakis with “the ability to adjust stimulation dependent on such sensing” (see paragraph 24 of Wagenbach).
Regarding claim 18, Giftakis teaches that “Electrical impulses occur as current flows through the body tissue between the one or more electrodes 28 on the intracranial lead 23 and the remote electrode 14. In this and other embodiments, the remote electrode 14 is adapted to function in various capacities, including as a reference electrode for sensing electrical signals including EEG signals, and as an indifferent electrode during monopolar stimulation” (see paragraph 28).
Regarding claim 19, Wagenbach teaches that “the differential amplifier 111 will ideally subtract artifacts in the tissue (i.e., stimulation artifact 134 and artifacts related to passive charge recovery) as a common mode voltage from the output (Vo), leaving only the ECAP to be sensed” (see paragraph 66). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to utilize this technique within Giftakis in order to “leaving only the ECAP to be sensed”, thereby allowing for proper adjustment of the stimulation based on the sensing (see paragraph 24 of Wagenbach).
Regarding claim 20, Giftakis discloses “An assembly for sensing physiologic signals and delivering monopolar stimulation therapy” (see Abstract). Specifically, Giftakis teaches a stimulator device system for providing stimulation to a patient's brain (see Figures 1, 2 and 6B), comprising:
a stimulator device (see the system illustrated in Figure 1, for example) comprising a case (see case illustrated in Figures 3-4) and a plurality of electrodes comprising a case electrode associated with the case (see electrode 14 in Figures 3-4; see paragraphs 28-29) and other electrodes different from the case electrode (see electrode 42 in Figure 4, electrode 16 in Figure 5, electrode 28 in Figure 6B, and electrode 19 in Figure 8), wherein one or more first of the other electrodes are configured to be provided within the patient's brain (see electrodes 28 in Figure 6B), and wherein one or more second of the other electrodes are configured to be provided within the patient's head but not within the brain (see any one of electrodes 16, 18 and/or 19 within Figures 6A, 6B, 7 and 8, noting that electrode 16 is located on connector 22 and is shown in Figures 1 and 6B as being located “within the head” region of the patient);
stimulation circuitry within the case configured to provide stimulation between at least two of the plurality of electrodes (see paragraph 26, “An implantable pulse generator (IPG) 10 is implanted proximate to the patient's clavicle. The IPG 10 includes a pulse generating source”; note that in paragraph 24 it discusses that the “electrode can function as an indifferent electrode for monopolar stimulation” and paragraph 25 teaches that “Each of the monopolar stimulation assemblies described hereafter produces electrical impulses as a fully implantable system. Electrical impulses occur as current flows between an active electrode and an indifferent electrode through the body tissue”; see paragraph 27, “One aspect of the inventive monopolar stimulation assembly includes positioning the indifferent electrode away from the IPG 10 and in remote locations with respect to the electrodes 28. For this reason, the indifferent electrode will hereafter be referred to as a remote electrode”, noting that each of electrodes 14, 16, 18, 19 and 42 are all described as “remote electrodes” within the disclosure); and
sense amplifier circuitry within the case configured to sense a tissue signal in the brain using at least one of the first electrodes as a primary sensing electrode (see paragraph 25 which teaches that “The assembly depicted in FIG. 1 is a deep brain EEG sensing and stimulation system for the detection and termination of epileptic seizures”; also see paragraph 5 which teaches that “Standard diagnostic EEG sensing requires two electrodes in contact with body tissue. The first electrode is placed near the desired source of the electrical activity that the physician desires to monitor, and is referred to as active. The second electrode, referred to as the reference, is typically placed outside of the cranium away from the desired source of electrical activity”) and using at least one of the second electrodes as a sensing reference electrode (note that paragraphs 28 teaches that electrode 14 is a reference electrode; note that paragraph 39 teaches that “the remote electrode can be used as a reference electrode to sense neurological activity”, thereby teaching that each one of electrodes 16, 18 and/or 19 can be used as reference electrodes during EEG sensing).
It is noted that Giftakis a case electrode associated with the case (see electrode 14 in Figures 3-4; see paragraphs 28-29), this “remote electrode 14 is positioned on the header block 12 instead of the IPG 10”. Although Giftakis does state that “conventional monopolar stimulation assemblies utilize a conductive area of the IPG housing as a remote electrode” (see paragraph 32).
Wagenbach teaches that “Implantable neurostimulator devices are devices that generate and deliver electrical stimuli to body nerves and tissues for the therapy of various biological disorders, such as … cortical and deep brain stimulators to treat motor and psychological disorders… present invention may find applicability with any implantable neurostimulator device system” (see paragraph 3). As taught in paragraph 9, “IPG 10 as mentioned includes stimulation circuitry 28 to form prescribed stimulation at a patient's tissue… The stimulation circuitry 28 in this example also supports selection of the conductive case 12 as an electrode (Ec 12), which case electrode is typically selected for monopolar stimulation.”
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to use a conductive area of the IPG housing itself as the remote electrode, as hinted at in Giftakis within paragraph 32, and as explicitly taught within the system and methods of Wagenbach, because Giftakis teaches that this can be done with some IPGs, while Wagenbach explicitly teaches to do this in a working example. As such a modification amounts to substitution of known equivalents for providing a remote/reference electrode at the location of the IPG to yield predictable results (KSR v. Teleflex).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Giftakis in view of Wagenbach as applied to claim 11 above, further in view of Bakker et al. (US Patent Pub. No. 2016/0144189).
Giftakis in combination with Wagenbach is described above with respect to claim 11. However, neither of these references teach that the remote/reference electrodes are flexible.
Bakker teaches “electrical stimulation and sensing and, more particularly, electrodes for electrical stimulation therapy and sensing” (see Abstract). Figure 1 illustrates that this is specifically a system for stimulation/sensing in the brain via a controller located in the torso, which is similar to that of Giftakis and Wagenbach. Bakker states that “In general, the disclosure describes techniques, devices, and systems that include a grounding electrode (e.g., a return electrode) for a multi-module system… The grounding electrode may be located between the first module and the second module. In one example, the grounding electrode may be carried on a connecting cable that transfers power and/or stimulation signals between the first and second modules” (see paragraph 4). In other words, the grounding electrode may be placed between the controller or IPG 110 and second module 111, i.e., along connecting cable 120 (see Figure 3, also see connecting cable 120 in Figure 1). This is akin to a grounding or reference or remote electrode at a location similar to electrode 16 on connector 22 within the disclosure of Giftakis. In one example grounding electrode, it is taught to use a coiled conductor (see paragraph 86, which teaches “The coiled configuration of the conductor is flexible and can provide increased flexibility to connecting cable 120E and elongated body 121E as compared to having a solid ring electrode over elongated body 121E”). Paragraph 87 also teaches that “In other examples, portions of the electrode may be removed along the length of the structure to create a flexible structure, such as semi-circular arches running lengthwise along the electrode. The flexible structure may then be capable of flexing like a coil without being a coiled conductor.” And paragraph 96 teaches that “In other examples, ring electrodes 350A and 350B (or a single ring electrode) may be a laser-cut tube with the cut-out pattern forming a flexible structure (e.g., coil wire 352A and 352B) that allows the grounding electrode to be flexible for connecting cable 120H.” Also see paragraphs 92-94 for another example.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to utilize structures, materials and designs for a flexible grounding/reference/remote electrode within the system and methods of Giftakis as combined with Wagenbach, as is taught by Bakker in order to improve the flexibility of connecting cables upon which an electrode may reside, thereby allowing for placement of a grounding electrode at nearly any location along the connecting cables (see paragraphs 32-33 for discussion of improvements to certain locations over others). This would allow a remote electrode to be placed at any location between the IPG and the burr hole within the system of Giftakis, without being limited to the location of the connector 22, thereby improving utility of the design.
Conclusion
Additional prior art that is considered pertinent to applicant's disclosure can be found in the accompanying PTO-892.
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/JAMES KISH/ Primary Examiner, Art Unit 3792
