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 .
Response to Amendment
The amendment filed on 01/13/2026 has been entered. Claims 1-6, 10-15 and 19-20 remain pending.
The previously raised 112 rejections with regard to Claims 4, 7 and 16 have been overcome by either properly correcting the issue or cancelling the claim.
Response to Arguments
On Pages 10-15, Applicant discusses 101 rejections with regard to independent Claims 1 and 13.
On Pages 11-14, Applicant argues that the claims (especially as amended) are not directed to an abstract idea, with Claim 1 reciting “measuring contacts, a stimulating contact, a waveform generator, and a processor, and thus is a machine” (Page 11), and Claim 1 and 13 describing “a specific measurement-and-control architecture for applied stimulation in tissue with closed-loop adjustment” (Page 11). After presenting the amended Claim 1 on Pages 11-12, Applicant further argues on Page 13 that Claims 1 and 13 recites “a specific medical/electro-technical system and method”, with features of (a)-(d). Examiner respectfully disagrees.
Regarding feature (a) of “uses physical measuring contacts placed at defined locations in biological tissue to obtain voltage measurements”, both “measuring contacts” and “point-of-contact” (or “location” as cited here) are recited in a very high level of generality. For example, the recited “measuring contact” is merely a generic electrical contact, and the “point-of-contact” is not defined in the claims and can be any location of biological tissue. Therefore, the elements in feature (a) do not impose any meaningful limit on practicing the abstract idea.
Regarding feature (b) of “determines a local electric field differential between two measuring contacts using a finite-difference relation in a 1-D collinear arrangement (with distance defined as the inter-contact spacing)”, the claimed determining of electric field differential follows a basic relationship of electrostatics, so this element recites an abstract idea and/or a law of nature.
Regarding feature (c) of “leverages the disclosed 1-D distance definition in which the stimulating source coordinate cancels when expressing the inter-contact distance as a difference between measuring-contact positions”, this element refers to “Іx2 – x1І is equal to І(x2-x0) – (x1-x0)І” in a context of electric field in Claims 1 and 13, which recites a mathematical concept and/or a law of nature.
Regarding feature (d) of “uses the resulting measured/determined field magnitude as real-time feedback in a closed-loop system to adjust stimulation to achieve/restore a required/desired field strength at tissue” (and additional discussion in the last paragraph of Page 13), this feature refers to Lines 46-52 of Claim 1, “in response to determining that the magnitude of the first electric field differential …, automatically adjust an input voltage … until the magnitude of the first electric field differential …”. The claimed “the first electric field differential” is determined based on a difference between V1 and V2, i.e. voltage values at two points of contact (Lines 40-44 of Claim 1). In other words, what is claimed is to adjust a stimulating voltage so that a voltage drop in tissue of interest reaches a required level. To a person having ordinary skill in the art, such claimed method is a straightforward method of applying any controlled electrical stimulation to biological tissue, so can be regarded as merely a step of data gathering.
On Pages 14-15, Applicant argues that the claims (especially as amended) recite significantly more than abstract idea. Specifically, on Page 14, Applicant argues that the claims recite additional elements that is not merely “generic electrodes and a processor”, e.g. (a) a 1-D, two-contact physical arrangement and inter-contact definition of Δd, and (b) a closed-loop stimulation adjustment, which are “not mere data gathering extras but a particular control architecture for applied tissue stimulation using real-time field feedback”. On Page 15, Applicant argues that, with current amendments, the element of the measured/determined field magnitude is now tied with “automatic adjustment of stimulation to reach/maintain a required/desired field magnitude”, and therefore “applying a voltage … with a waveform generator” is not merely a data gathering or insignificant activity. Examiner respectfully disagrees.
Regarding the argument on Page 14, “(a) a 1-D, two-contact physical arrangement and inter-contact definition of Δd, where source location cancels …”, positioning two measuring contacts on a 1-D arrangement with a distance in between does not provide specific improvement over prior art. Implantable electrode with multiple contacts is widely used in both electrical measurement and stimulation, so it is common to position two different contacts along a line with different distances from stimulating point. As a separate issue, the argument recites “a 1-D, two-contact physical arrangement”, which appears to physically arrange the one stimulating contact and the two measuring contacts on a common axis. This contradicts with Figs 2-3, and also possibly with Claim 2 that claims the electrode to be single-contact.
Regarding the argument on Page 14, “(b) a closed-loop stimulation adjustment to achieve/restore a required/desired field magnitude in tissue”, and on Page 15, “a waveform generator” not being part of data gathering because of the explicit tire of “the measured field magnitude to automatic adjustment of stimulation”, as discussed above for feature (d), what is claimed is essentially to adjust a stimulating voltage so that a voltage drop in tissue of interest reaches a required level. Such adjustment based on a basic relationship between voltage difference and electric field magnitude is a straightforward way of applying controlled electrical stimulation to a person having ordinary skill in the field, but not a particular control architecture that recites specific improvements over prior art.
On Pages 18-21, Applicant discusses 102 rejections with regard to amended Claims 1 and 13, and argues that reference Marnfeldt does not disclose the features 1-3 listed in Page 18.
On Pages 18-19, Applicant argues that Marnfeldt “describes defining positions in three-dimensional space … rather than the claimed 1-D cancellation-based inter-contact Δd definition” (Page 18), specifically “(i) defining a measuring-contact spacing Δd as Іx2 – x1І along a common axis and (ii) explicitly reciting the cancellation identity І(x2-x0) – (x1-x0)І such that Δd is independent of x0” (Page 19). Examiner respectfully disagrees. While Marnfeldt does disclose positioning electrodes and determining electric field in three-dimensional space, it also discloses the features (i) and (ii) as claimed. For example, in Fig. 1A of Marnfeldt, multiple tissue-stimulating electrodes 16 are arranged in either a percutaneous lead 15 or a paddle lead 19. Fig. 1B shows an arrangement with electrodes E1, E2-4, E5-7 and E8 on different positions of the central axis 31. For example, electrode E1 is at a proximal end of the lead, while E8 is at the distal end. Para 0060 and Fig. 6 of Marnfeldt disclose that a user can select which of the plurality of the electrodes to be cathode or anode, so any three electrodes on different longitudinal positions along the central axis in the examples can be selected to correspond to x0, x1 and x2 respectively. For example, in Fig. 6 of Marnfeldt, electrode Ec, which is connected to a line along the central axis can correspond to a stimulating contact with position x0, E2 can correspond to x1 and E5 to x2. The distance between E2 and E5 is independent of the position of electrode Ec.
On Pages 19-20, Applicant argues that Marnfeldt “computes … over a three-dimensional grid” (Page 19), and does not disclose “determining the claimed two-contact finite difference using only the two measured tissue voltages and the claimed Δd definition” (Page 20). Examiner respectfully disagrees. Marnfeldt, Para 0070 discloses “Another parameter received by the field modelling algorithm 116 is the bulk resistance of the tissue, p. This is beneficial so that the algorithm 116 can estimate the voltage at different points in the tissue surrounding the electrodes, and hence the strength of the electric field at those points (E=dV/dx).”; further in Para 0072, “Use of a bulk tissue resistance p assumes that tissue is homogenous, and has equal resistance in all directions in three-dimensional space”, which is a simplified scenario where resistance in space is equal everywhere and the differential form E=dV/dx can be written as its finite-difference form, i.e. E = (V2-V1)/(x2-x1). Marnfeldt, Para 0093 discloses “The field determination algorithm 175 essentially solves, given the current Is provided from selected electrodes Es, voltage drops across the directional resistances, and so can compute a voltage at each position 171. Thus, at position X1, Y1, Z1, a voltage V=M is computed, at position X2, Y1, Z1, a voltage V=N is computed, etc. These voltages in three-dimensional space define a three dimensional-electric field 172 (E(x,y,z)=dV/dx+dV/dy+dV/dz).”. This disclosure is an example that, with more realistic modeling by allowing heterogeneous directional resistance in three-dimensional space, Marnfeldt is obviously applicable for one-dimension homogeneous-resistance scenario.
On Pages 20-21, Applicant argues that Marnfeldt does not disclose a “closed-loop control scheme” that automatically adjust an input voltage of an applied waveform so that a measured electric field differential equals a required value. This argument is moot in view of the new grounds of rejection which relies on Simon et al (US 20110230938 A1) to disclose these limitations in the claims.
On Pages 22-23, Applicant discusses 103 rejections with regard to Claims 2, 5, 6, 10, 14, 15 and 19, and argues that Miocinovic or Bradley does not disclose the features 1-3 discussed above. As discussed above, the features 1-2 are disclosed in Marnfeldt, and the argument on the feature 3 is moot in view of the new grounds of rejection which relies on Simon et al (US 20110230938 A1).
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 1-6, 10-15 and 19-20 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, Lines 15-20, and Claim 13, Lines 16-21, define points of contact in a form of “define a point-of-contact at a position x along an X axis of a Cartesian coordinate system”. First, it is unclear whether the “point-of-contact” is on the “X axis”, or the “point-of-contact” is not necessarily on the “X axis” but has “x” as its X-axis coordinate; in other words, whether the three contacts (one stimulating contact and the two measuring contacts) are on a common line. For present purposes of examination, the recited “the stimulating contact”, “the first measuring contact” and “the second measuring contact” are interpreted to be not necessarily on a common line but have one coordinate on a same axis. Second, it is unclear how the recited “position x” is defined “along an X axis”. Specifically, the “position x” can be a distance of the point-of-contact to a reference point in polar coordinate system (see Figs. 2-3 of Specification), OR as recited in the claims, be a Cartesian coordinate along an axis, i.e. a line is drawn through the point-of-contact and perpendicular to the axis, and the coordinate is the position where the line meets the axis. For present purposes of examination, the recited “position x along an X axis” is interpreted to be a Cartesian coordinate along an axis.
Claim 1, Lines 37-44 recites “a magnitude of a first electric field differential” and describes how such a variable is determined. It is unclear whether the recited “electric field differential” refers to “electric field” or “differential of electric field”. For present purposes of examination, the recited “electric field differential” in Claim 1 and all its dependent claims is interpreted to refer to “electric field”.
Claim 1, Lines 46-48, and Claim 13, Lines 42-43, recite “the magnitude … is less than the required electric field strength value”. It is unclear whether the recited “magnitude” and “strength value” refer to a same variable. For present purposes of examination, all recited “strength value” in Claims 1 and 13 are interpreted to refer to “magnitude”.
Claim 13, Lines 34-36, recites “a magnitude of a first electric field differential between the first measuring contact and the second measuring contact”. It is unclear what the underlined part of the recited phrase means. Based on the claimed method of determining the variable (Claim 13, Lines 37-40), the recited phrase is interpreted to refer to “a magnitude of a first electric field”, for present purposes of examination.
Claims 2-6, 10-12, 14-15 and 19-20 are also rejected under 35 U.S.C. 112(b) because they inherit the indefiniteness of the claim(s) they respectively depend upon.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-6, 10-15 and 19-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1, Lines 15-17, and Claim 13, Lines 16-28, recite “defines a point-of-contact at a stimulating-contact x0 along an X axis of a Cartesian coordinate system”. Although there is literal use of “Cartesian space” and “Cartesian coordinate system” in Specification (Para 0022, 0023), a person having ordinary skill in the art would understand Figs. 2-3 and the description to appear to be describing polar coordinates since positions appear to be defined as distances from an origin point.
Claims 2-6, 10-12, 14-15 and 19-20 are also rejected under 35 U.S.C. 112(a) because they inherit the indefiniteness of the claim(s) they respectively depend upon.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-6, 10-15 and 19-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
With regard to Claims 1-6 and 10-12:
Step 1: the claims are drawn to a system/apparatus, one of the four statutory categories.
Step 2A, Prong One:
The claims recite the limitations of “access an intermediate radial distance value … based on an absolute value of a difference between … x2 and … x1 …” and “determine a magnitude of a first electric field differential using …” in Claim 1, “determine a first distance value …” and “subtract the second distance value from the first distance value …” in Claim 5, and “determine a magnitude of a second electric field differential between …” in Claim 10. These limitations are, under their broadest reasonable interpretation, limitations that cover performance of the limitation in the mind and/or by mathematical calculations. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind and/or by mathematical calculations but for the recitation of generic computer components such as a processor, then it falls within the “Mental Processes” grouping and/or “Mathematical Concepts” of abstract ideas. Accordingly, the claims recite an abstract idea.
Step 2A, Prong Two:
The judicial exceptions are not integrated into a practical application. In particular, the claims recite the additional elements – a processor, a waveform generator for generating a voltage waveform, a stimulating contact to apply a voltage at position of x0, a first and a second measuring contacts to measure voltage values at positions x1 and x2, accessing measured voltage values, and adjusting applied input voltage for a magnitude of electric field to reach a required level in Claim 1, an implantable depth electrode in Claim 2, an implantable multi-contact electrode in Claim 3, quantifying position of measuring contacts using imaging in Claim 6, accessing applied voltage value and a distance value between measuring contact and stimulating contact in Claim 10, mapping magnitude of electric field at a plurality of locations in Claim 11, switching a contact between measuring and stimulating in Claim 12. These additional elements are data gathering and accessing steps that are recited in a high level of generality, so are insignificant extra-solution activities. Accordingly, these additional elements do not integrate the judicial exceptions into a practical application because they do not impose any meaningful limits on practicing the abstract idea and law of nature. The claims are directed to an abstract idea and a law of nature.
Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the judicial exceptions into a practical application, the additional elements amount to no more than mere instructions to apply the exceptions using generic electrode and computer components, and cannot provide an inventive concept.
For the reasons set forth above, Claims 1-6 and 10-12 are not patent eligible.
With regard to Claims 13-15 and 19-20:
Step 1: the claims are drawn to a method/process, one of the four statutory categories.
Step 2A, Prong One:
The claims recite the limitations of “accessing an intermediate radial distance value … based on an absolute value of a difference between … x2 and … x1 …” and “determining a magnitude of a first electric field differential using …” in Claim 13, “determining a first distance value …” and “subtracting the second distance value from the first distance value …” in Claim 14, and “determine a magnitude of a second electric field differential between …” in Claim 19. These limitations are, under their broadest reasonable interpretation, limitations that cover performance of the limitation in the mind and/or by mathematical calculations. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind and/or by mathematical calculations but for the recitation of generic computer components such as a processor, then it falls within the “Mental Processes” grouping and/or “Mathematical Concepts” of abstract ideas. Accordingly, the claims recite an abstract idea.
Step 2A, Prong Two:
The judicial exceptions are not integrated into a practical application. In particular, the claims recite the additional elements – a processor, a stimulating contact to apply a voltage at position of x0, a first and a second measuring contacts to measure voltage values at positions x1 and x2, accessing measured voltage values, and adjusting applied input voltage for a magnitude of electric field to reach a required level in Claim 13, quantifying position of measuring contacts using imaging in Claim 15, accessing applied voltage value and a distance value between measuring contact and stimulating contact in Claim 19, and mapping magnitude of electric field at a plurality of locations in Claim 20. These additional elements are data gathering and accessing steps that are recited in a high level of generality, so are insignificant extra-solution activities. Accordingly, these additional elements do not integrate the judicial exceptions into a practical application because they do not impose any meaningful limits on practicing the abstract idea and law of nature. The claims are directed to an abstract idea and a law of nature.
Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the judicial exceptions into a practical application, the additional elements amount to no more than mere instructions to apply the exceptions using generic electrode and computer components, and cannot provide an inventive concept.
For the reasons set forth above, Claims 13-15 and 19-20 are not patent eligible.
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.
Claims 1, 3-4, 10-13 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Marnfeldt (US 20200001091 A1; hereafter Marnfeldt), in view of Simon et al (US 20110230938 A1; hereafter Simon).
With regard to Claim 1, Marnfeldt discloses a system, comprising:
a first measuring contact (electrode E2 in the example shown in Fig. 6) in communication with a processor (Marnfeldt, Para 0074; “… control circuitry 130, which in one example can comprise a microcontroller …”), wherein the first measuring contact in communication with the processor is operable to measure a first voltage value (Marnfeldt, Para 0076; “One or more control signal 137 issued by the field measurement algorithm 132 will select two of the electrode nodes ex and ey, thus passing their voltages Vex and Vey to the inputs of a differential amplifier 140”; for electrode E2, the voltage is Ve2) at a point-of-contact of the first measuring contact; and
a second measuring contact (electrode E5 in the example shown in Fig. 6) in communication with the processor, wherein the second measuring contact in communication with the processor is operable to measure a second voltage value (Marnfeldt, Para 0076; “One or more control signal 137 issued by the field measurement algorithm 132 will select two of the electrode nodes ex and ey, thus passing their voltages Vex and Vey to the inputs of a differential amplifier 140”; for electrode E5, the voltage is Ve5) at a point-of-contact of the second measuring contact;
a stimulating contact (Marnfeldt, Para 0004; “The IPG 10 includes a biocompatible device case 12 … “; Para 0007; “The conductive case 12 can also comprise an electrode (Ec).”) operable to apply an applied voltage to the tissue at a point-of-contact of the stimulating contact (Marnfeldt, Fig. 2A shows the voltage waveform applied to case electrode Ec); and
a waveform generator (IPG 10) in communication with the processor, wherein the waveform generator is operable for generating an applied voltage waveform (waveform in Fig. 2A) that is applied to the tissue by the stimulating contact (the case electrode Ec 12) (Marnfeldt, Para 0010; “Stimulation in IPG 10 is typically provided by pulses each of which may include a number of phases such as 30a and 30b, as shown in the example of FIG. 2A. … a current is provided between at least one selected lead-based electrode (e.g., E1) and the case electrode Ec 12.”);
wherein the stimulating contact defines a point-of-contact at a stimulating-contact position x0 (Marnfeldt, Fig. 1B shows the position of E2 and E5 (correspond to the two measuring contacts) along central axis 31. Fig. 6 also includes Ec (corresponds to the stimulating contact when selected so), which is displayed at a more proximal end of the lead (see Para 0060)) along an X axis of a Cartesian coordinate system (the central axis 31 in Fig. 1B), the first measuring contact defines a point-of-contact at a first measuring-contact position x1 along the X axis, and the second measuring contact defines a point-of-contact at a second measuring-contact position x2 along the X axis (Marnfeldt, Para 0005; “Electrodes E5, E6, and E7 … are located at a different longitudinal position along the central axis 31 than are split ring electrodes E1, E2, and E3.” The relative positions of E2 and E5 along the central axis 31 are displayed in Fig. 1B);
wherein the processor includes instructions (Marnfeldt, Para 0075; “Control circuitry 130 includes the field measurement algorithm 132”) which, when executed, cause the processor to:
access the first voltage value from the first measuring contact and the second voltage value from the second measuring contact (Marnfeldt, Para 0076; “One or more control signal 137 issued by the field measurement algorithm 132 will select two of the electrode nodes ex and ey, thus passing their voltages Vex and Vey to the inputs of a differential amplifier 140”. For E2 and E5, the voltages are Ve2 and Ve5 respectively, but any other two electrodes can be selected as measuring contacts, as described in Para 0060 and Fig. 6; Para 0060; “two or more electrodes can be chosen to act as anodes or cathodes at a given time, allowing the electric field in the tissue to be shaped, as explained further below.”);
access an intermediate radial distance value representative of a difference in a distance between the first measuring contact and the second measuring contact (Marnfeldt, Para 0069; “If more than one lead is used to form an electrode array 17 (FIG. 1A), leads database 115 may also provide information relevant to the spacing and orientation of one lead to another, which may be determined in any number of manners.”) along the X axis, wherein the intermediate radial distance value Δd is based on an absolute value of a difference between the second measuring-contact position x2 and the first measuring-contact position x1, and wherein Ix2 - x1I is equal to I(x2 - x0) - (x1 - x0)I such that the intermediate radial distance value is independent of the stimulating-contact position x0 (Marnfeldt, Fig. 1B shows that the distance between E2 and E5 along the central axis 31 is independent of the position of any stimulating electrode);
determine a magnitude of a first electric field differential using the first voltage value, the second voltage value, and the intermediate radial distance value according to
E
=
-
(
V
2
-
V
1
)
/
(
∆
d
)
(Marnfeldt, Para 0070; “the algorithm 116 can estimate the voltage at different points in the tissue surrounding the electrodes, and hence the strength of the electric field at those points (E=dV/dx).”), wherein V1 and V2 are respectively representative of the first voltage value and the second voltage value and Δd is representative of the intermediate radial distance value (Marnfeldt, Para 0093; “at position X1, Y1, Z1, a voltage V=M is computed, at position X2, Y1, Z1, a voltage V=N is computed, etc. These voltages in three-dimensional space define a three dimensional-electric field 172 (E(x,y,z)=dV/dx+dV/dy+dV/dz).” Again in this example, both the distance between two points and the calculated E are independent of where stimulation is applied); and
adjust an input voltage of the applied voltage waveform (Marnfeldt, Para 0010; “Stimulation parameters typically include amplitude (current I, although a voltage amplitude V can also be used) …”).
Marnfeldt does not clearly and explicitly disclose
accessing a required electric field strength value; and
in response to determining that the magnitude of the first electric field differential is less than the required electric field strength value, automatically adjusting an input voltage of the applied voltage waveform to adjust the electric field strength until the magnitude of the first electric field differential is the required electric field strength value.
Simon in the same field of endeavor discloses
accessing a required electric field strength value (Simon, Para 0054; “the stimulation device produces an electric field in the vicinity of the nerve that is sufficient to cause the nerve to depolarize and reach a threshold for action potential propagation, which is approximately 8 V/m at 1000 Hz.”); and
in response to determining that the magnitude of the first electric field differential is less than the required electric field strength value, automatically adjusting an input voltage of the applied voltage waveform to adjust the electric field strength until the magnitude of the first electric field differential is the required electric field strength value (Simon, Para 0024; “The stimulator is configured to induce a peak pulse voltage sufficient to produce an electric field in the vicinity of a nerve such as a vagus nerve, to cause the nerve to depolarize and reach a threshold for action potential propagation.”; Para 0054; “included in the system is a measuring stage which measures and displays the electrical stimulation signal operating on the substance being treated as well as the outputs of various sensors which sense conditions prevailing in this substance whereby the user of the system can manually adjust it or have it automatically adjusted by feedback to provide an electrical stimulation signal of whatever type the user wishes, who can then observe the effect of this signal on a substance being treated.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Marnfeldt, as suggested by Simon, in order to automatically adjust stimulation parameter to achieve a sufficient strength of electric field. One of ordinary skill in the art would have been motivated to make the modification for the benefit of achieving the therapeutic effect of stimulation in an efficient and effective way.
With regard to Claim 3, Marnfeldt and Simon disclose the system of Claim 1. Marnfeldt further discloses wherein first measuring contact (E2) (Marnfeldt, Para 0078; “in FIG. 6, the case electrode 12 Ec is specified to receive X=100% of the current I as an anodic current +I. The corresponding cathodic current −I is split between electrodes E2 (0.18*−I), E4 (0.52*−I), E5 (0.08*−I), and E7 (0.22*−I).”) is a contact of a plurality of contacts on an implantable multi-contact electrode (Marnfeldt, Para 0060; “in FIG. 6, the leads interface 102 shows an image 103 of a single split-ring lead 33 … select an illustrated electrode 16 (e.g., E1-E8, or the case electrode Ec)”; Para 0062; “the lead(s) are implanted using a stereotactic frame …”).
With regard to Claim 4, Marnfeldt and Simon disclose the system of Claim 3. Marnfeldt further discloses wherein the implantable multi-contact electrode includes the stimulating contact (Marnfeldt, Para 0060; “in FIG. 6, the case electrode 12 Ec is specified to receive X=100% of the current I as an anodic current +I.”).
With regard to Claim 10, Marnfeldt and Simon disclose the system of Claim 1. Marnfeldt further discloses wherein the processor (Marnfeldt, Para 0075; “Control circuitry 130 includes the field measurement algorithm 132”) includes instructions which, when executed, cause the processor to:
access an applied voltage value (Ve1) associated with the stimulating contact (E1) (Marnfeldt, Para 0070; “Providing Itest between electrodes E1 and E2 will cause voltages Ve1 and Ve2 to form at their respective electrodes nodes 39”);
access a second distance value representative of a physical distance between the first measuring contact and the stimulating contact (Marnfeldt, Para 0085; “… the three-dimensional positioning of the electrodes—their size, location, and spacing—can be queried from the leads database 115 (FIG. 11) …”); and
determine a magnitude of a second electric field differential between the stimulation contact and the first measuring contact using the applied voltage value (Ve1), the first voltage value (Ve2), and the second distance value (Marnfeldt, Para 0070; “the algorithm 116 can estimate the voltage at different points in the tissue surrounding the electrodes, and hence the strength of the electric field at those points (E=dV/dx).”).
With regard to Claim 11, Marnfeldt and Simon disclose the system of Claim 1. Marnfeldt further discloses wherein the instructions which, when executed, further cause the processor to:
generate a mapping by determining the magnitude of electric field differential between a plurality of measuring contacts at a plurality of locations across an organic structure (Marnfeldt, Para 0093; “These voltages in three-dimensional space define a three dimensional-electric field 172 (E(x,y,z)=dV/dx+dV/dy+dV/dz).”).
With regard to Claim 12, Marnfeldt and Simon disclose the system of Claim 1. Marnfeldt further discloses wherein a measuring contact is configured to switch between a measuring contact role and a stimulating contact role (Marnfeldt, Para 0011; “electrode E1 has been selected as a cathode … The polarity of the currents at these electrodes can be changed: Ec can be selected as a cathode, and E1 can be selected as an anode, etc.”).
With regard to Claim 13, Marnfeldt discloses a method, comprising:
providing a first measuring contact (electrode E2 in the example shown in Fig. 6) in communication with a processor (Marnfeldt, Para 0074; “… control circuitry 130, which in one example can comprise a microcontroller …”), wherein the first measuring contact in communication with the processor is operable to measure a first voltage value (Marnfeldt, Para 0076; “One or more control signal 137 issued by the field measurement algorithm 132 will select two of the electrode nodes ex and ey, thus passing their voltages Vex and Vey to the inputs of a differential amplifier 140”; for electrode E2, the voltage is Ve2) of tissue at a point-of-contact of the first measuring contact;
providing a second measuring contact (electrode E5 in the example shown in Fig. 6) in communication with the processor, wherein the second measuring contact in communication with the processor is operable to measure a second voltage value (Marnfeldt, Para 0076; “One or more control signal 137 issued by the field measurement algorithm 132 will select two of the electrode nodes ex and ey, thus passing their voltages Vex and Vey to the inputs of a differential amplifier 140”; for electrode E5, the voltage is Ve5) of tissue at a point-of-contact of the second measuring contact;
providing a stimulating contact (Marnfeldt, Para 0004; “The IPG 10 includes a biocompatible device case 12 … “; Para 0007; “The conductive case 12 can also comprise an electrode (Ec).”) operable to apply an applied voltage to the tissue at a point-of-contact of the stimulating contact (Marnfeldt, Fig. 2A shows the voltage waveform applied to case electrode Ec);
providing a waveform generator (IPG 10) in communication with the processor, wherein the waveform generator is operable for generating an applied voltage waveform (waveform in Fig. 2A) that is applied to the tissue by the stimulating contact (the case electrode Ec 12) (Marnfeldt, Para 0010; “Stimulation in IPG 10 is typically provided by pulses each of which may include a number of phases such as 30a and 30b, as shown in the example of FIG. 2A. … a current is provided between at least one selected lead-based electrode (e.g., E1) and the case electrode Ec 12.”), wherein the stimulating contact defines a point-of-contact at a stimulating-contact position x0 (Marnfeldt, Fig. 1B shows the position of E2 and E5 (correspond to the two measuring contacts) along central axis 31. Fig. 6 also includes Ec (corresponds to the stimulating contact when selected so), which is displayed at a more proximal end of the lead (see Para 0060)) along an X axis of a Cartesian coordinate system (the central axis 31 in Fig. 1B), the first measuring contact defines a point-of-contact at a first measuring-contact position x1 along the X axis, and the second measuring contact defines a point-of-contact at a second measuring-contact position x2 along the X axis (Marnfeldt, Para 0005; “Electrodes E5, E6, and E7 … are located at a different longitudinal position along the central axis 31 than are split ring electrodes E1, E2, and E3.” The relative positions of E2 and E5 along the central axis 31 are displayed in Fig. 1B);
accessing, by the processor, the first voltage value from the first measuring contact and the second voltage value from the second measuring contact (Marnfeldt, Para 0076; “One or more control signal 137 issued by the field measurement algorithm 132 will select two of the electrode nodes ex and ey, thus passing their voltages Vex and Vey to the inputs of a differential amplifier 140”. For E2 and E5, the voltages are Ve2 and Ve5 respectively, but any other two electrodes can be selected as measuring contacts, as described in Para 0060 and Fig. 6; Para 0060; “two or more electrodes can be chosen to act as anodes or cathodes at a given time, allowing the electric field in the tissue to be shaped, as explained further below.”);
accessing, by the processor, an intermediate radial distance value Δd representative of a difference in a distance between the first measuring contact and the second measuring contact (Marnfeldt, Para 0069; “If more than one lead is used to form an electrode array 17 (FIG. 1A), leads database 115 may also provide information relevant to the spacing and orientation of one lead to another, which may be determined in any number of manners.”) along the X axis, wherein the intermediate radial distance value Δd is based on an absolute value of a difference between the second measuring-contact position x2 and the first measuring-contact position x1, and wherein Ix2 - x1I is equal to I(x2 - x0) - (x1 - x0)I such that the intermediate radial distance value is independent of the stimulating-contact position x0 (Marnfeldt, Fig. 1B shows that the distance between E2 and E5 along the central axis 31 is independent of the position of any stimulating electrode);
determining, by the processor, a magnitude of a first electric field differential between the first measuring contact and the second measuring contact using the first voltage value, the second voltage value, and the intermediate radial distance value according to
E
=
-
(
V
2
-
V
1
)
/
(
∆
d
)
(Marnfeldt, Para 0070; “the algorithm 116 can estimate the voltage at different points in the tissue surrounding the electrodes, and hence the strength of the electric field at those points (E=dV/dx).”), wherein V1 and V2 are respectively representative of the first voltage value and the second voltage value and Δd is representative of the intermediate radial distance value (Marnfeldt, Para 0093; “at position X1, Y1, Z1, a voltage V=M is computed, at position X2, Y1, Z1, a voltage V=N is computed, etc. These voltages in three-dimensional space define a three dimensional-electric field 172 (E(x,y,z)=dV/dx+dV/dy+dV/dz).” Again in this example, both the distance between two points and the calculated E are independent of where stimulation is applied); and
adjusting an input voltage of the applied voltage waveform (Marnfeldt, Para 0010; “Stimulation parameters typically include amplitude (current I, although a voltage amplitude V can also be used) …”).
Marnfeldt does not clearly and explicitly disclose
accessing a required electric field strength value; and
in response to determining that the magnitude of the first electric field differential is less than the required electric field strength value, automatically adjusting an input voltage of the applied voltage waveform to adjust the electric field strength until the magnitude of the first electric field differential is the required electric field strength value.
Simon in the same field of endeavor discloses
accessing a required electric field strength value (Simon, Para 0054; “the stimulation device produces an electric field in the vicinity of the nerve that is sufficient to cause the nerve to depolarize and reach a threshold for action potential propagation, which is approximately 8 V/m at 1000 Hz.”); and
in response to determining that the magnitude of the first electric field differential is less than the required electric field strength value, automatically adjusting an input voltage of the applied voltage waveform to adjust the electric field strength until the magnitude of the first electric field differential is the required electric field strength value (Simon, Para 0024; “The stimulator is configured to induce a peak pulse voltage sufficient to produce an electric field in the vicinity of a nerve such as a vagus nerve, to cause the nerve to depolarize and reach a threshold for action potential propagation.”; Para 0054; “included in the system is a measuring stage which measures and displays the electrical stimulation signal operating on the substance being treated as well as the outputs of various sensors which sense conditions prevailing in this substance whereby the user of the system can manually adjust it or have it automatically adjusted by feedback to provide an electrical stimulation signal of whatever type the user wishes, who can then observe the effect of this signal on a substance being treated.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Marnfeldt, as suggested by Simon, in order to automatically adjust stimulation parameter to achieve a sufficient strength of electric field. One of ordinary skill in the art would have been motivated to make the modification for the benefit of achieving the therapeutic effect of stimulation in an efficient and effective way.
With regard to Claim 19, Marnfeldt and Simon disclose the method of Claim 13. Marnfeldt further discloses wherein the stimulating contact is in further communication with a processor (Marnfeldt, Para 0075; “Control circuitry 130 includes the field measurement algorithm 132”), and wherein the processor includes instructions which, when executed, cause the processor to:
access an applied voltage value (Ve1) associated with the stimulating contact (E1) (Marnfeldt, Para 0070; “Providing Itest between electrodes E1 and E2 will cause voltages Ve1 and Ve2 to form at their respective electrodes nodes 39”);
access a second distance value representative of a physical distance between the first measuring contact and the stimulating contact (Marnfeldt, Para 0085; “… the three-dimensional positioning of the electrodes—their size, location, and spacing—can be queried from the leads database 115 (FIG. 11) …”); and
determine a magnitude of a second electric field differential between the stimulation contact and the first measuring contact using the applied voltage value (Ve1), the first voltage value (Ve2), and the second distance value (Marnfeldt, Para 0070; “the algorithm 116 can estimate the voltage at different points in the tissue surrounding the electrodes, and hence the strength of the electric field at those points (E=dV/dx).”).
With regard to Claim 20, Marnfeldt and Simon disclose the method of Claim 13. Marnfeldt further discloses generating a mapping of electric field differential between a plurality of measuring contacts at a plurality of locations across an organic structure (Marnfeldt, Para 0093; “These voltages in three-dimensional space define a three dimensional-electric field 172 (E(x,y,z)=dV/dx+dV/dy+dV/dz).”).
Claims 2, 5-6 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Marnfeldt and Simon, further in view of Miocinovic et al (Experimental Neurology 216 (2009) 166-176; hereafter Miocinovic).
With regard to Claim 2, Marnfeldt and Simon disclose all the limitations of Claim 1 as discussed above, but do not clearly and explicitly disclose wherein the first measuring contact is a single contact on an implantable depth electrode.
Miocinovic in the same field of endeavor discloses wherein the first measuring contact is a single contact on an implantable depth electrode (Miocinovic, Page 167, right column, Para 3; “In both cases epoxylitecoated tungsten microelectrodes with tip lengths of approximately 50 μm (FHC, Bowdoinham, ME) were positioned at different vertical and horizontal distances from the DBS electrode using a microdrive …”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Marnfeldt and Simon, as suggested by Miocinovic, in order to use a single contact on an implantable depth electrode as measuring contact. One of ordinary skill in the art would have been motivated to make the modification for the benefit of flexibly varying the position of the electrode relative to the stimulating electrode to generate electric field map of fine resolution (Miocinovic, Page 167, right column, Para 3; “Vertical spatial resolution was 0.25-0.5 mm while horizontal resolution was 0.5-1 mm.”).
With regard to Claim 5, Marnfeldt and Simon disclose all the limitations of Claim 1 as discussed above, but do not clearly and explicitly disclose wherein the instructions which, when executed, further cause the processor to:
determine a first distance value representative of a distance between the first measuring contact and the stimulating contact, and a second distance value representative of a distance between the second measuring contact and the stimulating contact; and
subtract the second distance value from the first distance value to obtain the intermediate radial distance value between the first measuring contact and the second measuring contact.
Miocinovic in the same field of endeavor discloses wherein the instructions which, when executed, further cause the processor to:
determine a first distance value representative of a distance between the first measuring contact and the stimulating contact, and a second distance value representative of a distance between the second measuring contact and the stimulating contact (epoxylitecoated tungsten microelectrodes are positioned at different vertical and horizontal distances from the DBS electrode); and
subtract the second distance value from the first distance value to obtain the intermediate radial distance value between the first measuring contact and the second measuring contact (vertical resolution of 0.25 - 0.5 mm, and horizontal resolution of 0.5 - 1 mm; each of these resolution values is subtraction result between two adjacent positions of voltage measurement) (Miocinovic, Page 167, right column, Para 3; “In both cases epoxylitecoated tungsten microelectrodes with tip lengths of approximately 50 μm (FHC, Bowdoinham, ME) were positioned at different vertical and horizontal distances from the DBS electrode using a microdrive (MO-95-lp, Narishige Scientific Instruments, Tokyo, Japan). Vertical spatial resolution was 0.25 - 0.5 mm while horizontal resolution was 0.5 - 1 mm.” See Fig. 1 C as an example).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Marnfeldt and Simon, as suggested by Miocinovic, in order to determine the distance values for the measuring contacts and further determine the intermediate radial distance value between the contacts. One of ordinary skill in the art would have been motivated to make the modification for the benefit of mapping voltage measurements for further derivation of electric field or electrical conductivity in the region around the measuring contacts (Miocinovic, Page 167, left column, Para 2; “By varying the vertical and horizontal distance of the microelectrode from the DBS electrode, multiple recordings were obtained and voltage distribution maps were constructed.”).
With regard to Claim 6, Marnfeldt, Simon and Miocinovic disclose all the limitations of Claim 5 as discussed above. Marnfeldt further discloses wherein the instructions which, when executed, further cause the processor to:
quantify a first position of the first measuring contact and a second position of the second measuring contact using imaging (Marnfeldt, Para 0062; “The visualization interface 106 preferably, but not necessarily, further includes tissue imaging information 114 taken from the patient … Such tissue imaging information may comprise a Magnetic Resonance Image (MM) … the location of the lead(s) can be precisely referenced to the tissue structures 114i because the lead(s) are implanted using a stereotactic frame”; Fig. 6, visualization interface 106 shows the position of E2 and E5 relative to surrounding tissue structures 114a, 114b and 114c).
With regard to Claim 14, Marnfeldt and Simon disclose all the limitations of Claim 13 as discussed above, but do not clearly and explicitly disclose:
determining a first distance value representative of a distance between the first measuring contact and the stimulating contact, and a second distance value representative of a distance between the second measuring contact and the stimulating contact; and
subtracting the second distance value from the first distance value to obtain the intermediate radial distance value between the first measuring contact and the second measuring contact.
Miocinovic in the same field of endeavor discloses determining a first distance value representative of a distance between the first measuring contact and the stimulating contact, and a second distance value representative of a distance between the second measuring contact and the stimulating contact (epoxylitecoated tungsten microelectrodes are positioned at different vertical and horizontal distances from the DBS electrode); and
subtracting the second distance value from the first distance value to obtain the intermediate radial distance value between the first measuring contact and the second measuring contact (vertical resolution of 0.25 - 0.5 mm, and horizontal resolution of 0.5 - 1 mm; each of these resolution values is subtraction result between two adjacent positions of voltage measurement) (Miocinovic, Page 167, right column, Para 3; “In both cases epoxylitecoated tungsten microelectrodes with tip lengths of approximately 50 μm (FHC, Bowdoinham, ME) were positioned at different vertical and horizontal distances from the DBS electrode using a microdrive (MO-95-lp, Narishige Scientific Instruments, Tokyo, Japan). Vertical spatial resolution was 0.25 - 0.5 mm while horizontal resolution was 0.5 - 1 mm.” See Fig. 1 C as an example).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Marnfeldt and Simon, as suggested by Miocinovic, in order to determine the distance values for the measuring contacts and further determine the intermediate radial distance value between the contacts. One of ordinary skill in the art would have been motivated to make the modification for the benefit of mapping voltage measurements for further derivation of electric field or electrical conductivity in the region around the measuring contacts (Miocinovic, Page 167, left column, Para 2; “By varying the vertical and horizontal distance of the microelectrode from the DBS electrode, multiple recordings were obtained and voltage distribution maps were constructed.”).
With regard to Claim 15, Marnfeldt, Simon and Miocinovic disclose all the limitations of Claim 14 as discussed above. Marnfeldt further discloses comprising:
quantifying a first position of the first measuring contact and a second position of the second measuring contact using imaging (Marnfeldt, Para 0062; “The visualization interface 106 preferably, but not necessarily, further includes tissue imaging information 114 taken from the patient … Such tissue imaging information may comprise a Magnetic Resonance Image (MM) … the location of the lead(s) can be precisely referenced to the tissue structures 114i because the lead(s) are implanted using a stereotactic frame”; Fig. 6, visualization interface 106 shows the position of E2 and E5 relative to surrounding tissue structures 114a, 114b and 114c).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/L.Z./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798