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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/07/2026 has been entered.
Response to Amendment
Claims 1, 5-6, 10-11, 13-15 and 19-20 have been amended. Claims 1-6, 10-15 and 19-20 remain pending.
The previously raised 112b rejections with regard to the feature of point-of-contact along the X axis, for Claims 1-6, 10-15 and 19-20, are withdrawn because the issue has been properly addressed.
The previously raised 112a rejections with regard to the feature of the Cartesian coordinate system, for Claims 1-6, 10-15 and 19-20, are withdrawn.
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 16-19, Applicant discusses 103 rejections with regard to amended Claims 1 and 13, and argues that reference Marnfeldt discloses a 3D modelling of electric field, but does not teach the amended common-axis point-of-contact geometry, or estimating a local in-tissue finite-difference differential quantity between two contact locations. Examiner respectfully disagrees. Even though the focus of Marnfeldt is to model electric field in a 3D space of tissue, it relies on multiple voltage measurements performed by electrode contacts being aligned along a longitudinal axis of an implantable lead. On the contrary, it is reference Marnfeldt but not the claimed method that is capable of determining “local” electric field parameters. The claimed method uses the simple formula to determine E based on voltages at two different points. Such determined E is not the exact E level at either of the two points, but a rough estimate of electric field strength around the region that covers the two points. Marnfeldt instead takes measurements of voltage at multiple points and applies advanced modeling approach to estimate electric field strength at every point in a field of interest, which also covers the locations of the electrode contacts.
Claim Objections
Claims 5-6, 11 and 19 are objected to because of the following informalities:
Claims 5-6 and 11, Lines 1-2, recite “wherein the instructions which, … further cause …”, which should be changed to “wherein the instructions
Claim 19, Lines 7-8, “… and the stimulating contact …” should be deleted.
Appropriate correction is required.
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 40-52, and Claim 13, Lines 37-45, recite “a magnitude of a first electric field differential representing a difference in electric field strength between … the first measuring contact and … the second measuring contact … according to
E
=
-
(
V
2
-
V
1
)
/
(
∆
d
)
…”, and Claim 10, Lines 8-11, recites “a magnitude of a second electric field differential representing a difference in electric field strength between …”. On the one hand, the recited formula computes an electric field strength based on voltage values (V1 and V2) at two points, which seemingly assumes a uniform electric field, i.e. for the two points, voltage level is different but electric field strength is the same. On the other hand, in the same recited paragraph, it is explicitly claimed that the “electric field differential” represents “a difference in electric field strength between” the two points. It is unclear whether the claimed “electric field differential” is an electric field strength or its difference between two spatial points. For present purposes of examination, Examiner does not consider the feature of “representing a difference in electric field strength between the point-of-contact of the first measuring contact and the point-of-contact of the second measuring contact” in Claims 1, 10 and 13, and interprets the recited “electric field differential” in the claims to refer to “electric field”.
Claims 2-6, 11-12, 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.
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 (electrode E1 in the example shown in Fig. 6 and Fig. 1B) operable to apply an applied voltage to the tissue at a point-of-contact of the stimulating contact (Marnfeldt, Para 0011; “In the example of FIG. 2A, electrode E1 has been selected as a cathode (during its first phase 30a), and thus provides pulses which sink a negative current of amplitude −I from the tissue.”); 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 (electrode E1) (Marnfeldt, Para 0010; “Stimulation parameters typically include amplitude (current I, although a voltage amplitude V can also be used); … the electrodes 16 selected to provide the stimulation; and the polarity of such selected electrodes, i.e., whether they act as anodes that source current to the tissue or cathodes that sink current from the tissue.” This disclosure indicates that every electrode can be set as the claimed stimulating contact);
wherein the stimulating contact defines a point-of-contact at a stimulating-contact position x0 (Marnfeldt, Fig. 1B shows the position of E1 along central axis 31) 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.”), and wherein the point-of-contact of the stimulating contact, the point-of-contact of the first measuring contact, and the point-of-contact of the second measuring contact are collinear on the X axis (Marnfeldt, Fig. 1B (cited below) shows that one point of contact of E1, one point of contact of E2 and one point of contact of E5 are collinear on a line parallel to the central axis 31);
Fig. 1B of Marnfeldt
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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 Δd representative of a difference in a distance between the point-of-contact of the first measuring contact and the point-of-contact of 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 representing a difference in electric field strength between the point-of-contact of the first measuring contact and the point-of-contact of 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
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 differential magnitude value; and
in response to determining that the magnitude of the first electric field differential is less than the required electric field differential magnitude 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 differential magnitude value.
Simon in the same field of endeavor discloses
accessing a required electric field differential magnitude 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 differential magnitude 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 differential magnitude 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 point-of-contact of 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 point-of-contact of the first measuring contact and the point-of-contact of 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) …”) along the X axis; and
determine a magnitude of a second electric field differential representing a difference in electric field strength between the point-of-contact of the stimulation contact and the point-of-contact of 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 magnitudes of electric field differentials 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 (electrode E1 in the example shown in Fig. 6 and Fig. 1B) operable to apply an applied voltage to the tissue at a point-of-contact of the stimulating contact (Marnfeldt, Para 0011; “In the example of FIG. 2A, electrode E1 has been selected as a cathode (during its first phase 30a), and thus provides pulses which sink a negative current of amplitude −I from the tissue.”);
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 (electrode E1) (Marnfeldt, Para 0010; “Stimulation parameters typically include amplitude (current I, although a voltage amplitude V can also be used); … the electrodes 16 selected to provide the stimulation; and the polarity of such selected electrodes, i.e., whether they act as anodes that source current to the tissue or cathodes that sink current from the tissue.” This disclosure indicates that every electrode can be set as the claimed stimulating contact), wherein the stimulating contact defines a point-of-contact at a stimulating-contact position X0 (Marnfeldt, Fig. 1B shows the position of E1 along central axis 31) 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.”), and wherein the point-of-contact of the stimulating contact, the point-of-contact of the first measuring contact, and the point-of-contact of the second measuring contact are collinear on the X axis (Marnfeldt, Fig. 1B (cited above) shows that one point of contact of E1, one point of contact of E2 and one point of contact of E5 are collinear on a line parallel to the central axis 31);
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 point-of-contact of the first measuring contact and the point-of-contact of 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 representing a difference in electric field strength between the point-of-contact of the first measuring contact and the point-of-contact of 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 differential magnitude value; and
in response to determining that the magnitude of the first electric field differential is less than the required electric field differential magnitude 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 differential magnitude value.
Simon in the same field of endeavor discloses
accessing a required electric field differential magnitude 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 differential magnitude 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 differential magnitude 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 point-of-contact of 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 point-of-contact of the first measuring contact and the stimulating contact and the point-of-contact of the stimulating contact along the X axis (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 differentials 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 point-of-contact of the first measuring contact and the point-of-contact of the stimulating contact along the X axis, and a second distance value representative of a distance between the point-of-contact of the second measuring contact and the point-of-contact of the stimulating contact along the X axis; and
determine the intermediate radial distance value as an absolute value of a difference between the second distance value and the first distance value.
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 point-of-contact of the first measuring contact and the point-of-contact of the stimulating contact along the X axis, and a second distance value representative of a distance between the point-of-contact of the second measuring contact and the point-of-contact of the stimulating contact along the X axis (epoxylitecoated tungsten microelectrodes are positioned at different vertical and horizontal distances from the DBS electrode); and
determine the intermediate radial distance value as an absolute value of a difference between the second distance value and the first distance value (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 the stimulating-contact position X0, the first measuring-contact position X1, and the second measuring-contact position X2 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 E1, 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 point-of-contact of the first measuring contact and the point-of-contact of the stimulating contact along the X axis, and a second distance value representative of a distance between the point-of-contact of the second measuring contact and the point-of-contact of the stimulating contact along the X axis; and
determining the intermediate radial distance value as an absolute value of a difference between the second distance value and the first distance value.
Miocinovic in the same field of endeavor discloses
determining a first distance value representative of a distance between the point-of-contact of the first measuring contact and the point-of-contact of the stimulating contact along the X axis, and a second distance value representative of a distance between the point-of-contact of the second measuring contact and the point-of-contact of the stimulating contact along the X axis (epoxylitecoated tungsten microelectrodes are positioned at different vertical and horizontal distances from the DBS electrode); and
determining the intermediate radial distance value as an absolute value of a difference between the second distance value and the first distance value (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 comprising one or more CT scans or MRI scans (Marnfeldt, Para 0062; “… tissue imaging information 114 taken from the patient, represented as three different tissue structures 114a, 114b and 114c in FIG. 6 … may comprise a Magnetic Resonance Image (MM), a Computed Tomography (CT) image … the location of the lead(s) can be precisely referenced to the tissue structures 114i …”), wherein the first position, the second position, and the position of the stimulating contact are positions along a single axis of a three-dimensional Cartesian coordinate system (Marnfeldt, Fig. 1B (cited above) shows that one point of contact of E1, one point of contact of E2 and one point of contact of E5 are collinear on a line parallel to the central axis 31. Fig. 6 shows both a longitudinal view and a cross-section view in a x-y-z coordinate system), and wherein the first distance value and the second distance value are determined using the first position, the second position, and the position of the stimulating contact (see discussion for Claim 14 above).
Conclusion
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/L.Z./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
