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 .
Status of Claims
In the response dated April 15th, 2026, Applicant amended claims 58-59, 61-65, 67, 73, and 81. Claims 78-80 are canceled. Applicant added claims 90-91. Claims 58-67, 73-77, 81, and 90-91 are pending.
Priority
The current application claims benefit of provisional application 62952717, filed on December 23rd, 2019. Examiner acknowledges the applicant’s claim for priority.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 07/28/2021 and 10/03/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS have being considered by the examiner.
Response to Arguments
In response to the argument put forward in the amendment, Examiner will address them in the order they were presented.
Regarding page 11, Applicant’s arguments regarding specification and claim objections have been considered. Applicant’s amendments overcome the claim and specification objections and the rejections are therefore withdrawn.
Regarding page 12, Applicant’s arguments regarding claim 67’s rejection under 35 U.S.C. 112 has been considered but is unpersuasive. Examiner found no changes to the language of “the manufacturing of the delivery device”. Appropriate correction to “manufacturing of the delivery device” is recommended.
Regarding page 12, Applicant’s arguments regarding claim 73, 78 and 81’s rejection under 35 U.S.C. 112 been considered. Applicant's amendments to the claims have overcome the rejections to claims 73, 78, and 81 under 35 U.S.C. 112 and the rejections are therefore withdrawn.
Regarding page 14, Applicant’s arguments that the amended claims should undergo a streamlined analysis have been considered but unpersuasive. Applicant argues because the claims clearly does not seek to tie up any judicial exception such that others cannot practice it. Examiner respectfully disagrees. MPEP 2106.06 describes that a streamlined analysis can occur when the claim’s eligibility is self-evident. The claims were previously directed to ineligible subject matter under 35 U.S.C. 101 because it recites abstract ideas without a judicial exception. The amendments of detecting lead migration and comparing resistivity profiles additionally recite the abstract idea material and do not recite an improvement to any underlying technology. Therefore, Examiner maintains the detailed analysis as written.
Regarding page 15, Applicant’s arguments have been considered but are unpersuasive. Applicant argues that the amended claim language improves the storage and processing of information for implantable leads. The Examiner respectfully disagrees. MPEP 2106.05(a) "It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II, below. In addition, the improvement can be provided by the additional element(s) in combination with the recited judicial exception.". Here, the processing of information related to lead position is directed to an abstract idea in the form of a mental process and therefore does not amount to an improvement of a technology. Examiner maintains that claim 58 and dependent claims are directed towards ineligible subject matter.
Regarding page 15, Applicant’s arguments have been considered but are unpersuasive. Applicant argues that the amended claim language does not recite a mental process because the measuring impedances cannot be performed in a human mind. Examiner indicates that the measuring of impedances as recited as insignificant pre-solution data-gathering (see OA, page 6). That the underlying data is obtained with physical electrodes does not render the subsequent analysis non-abstract. The claimed improvement lies in mathematical determination, which can be performed be a practitioner using observation and calculation. Therefore, Examiner maintains the claims recite ineligible subject matter.
Regarding page 16, Applicant’s arguments regarding improvement to the field of technology have been considered but are unpersuasive. MPEP 2106.04(d)(1) states “the word ‘improvements’ in the context of this consideration is limited to improvements to the functioning of a computer or any other technology/technical field, whether in Step 2A Prong Two or in Step 2B.” Here, there is no improvement to the implantable electrode storage hardware nor is there an improvement to another technology of delivery devices. Rather, Applicant’s own specification indicates that “delivery devices that treat a patient and/or record patient data are known” [0004]. Because neither type of improvement is present in the claims, an improvement to technology is not present and there is no practical application.
Regarding page 16, Applicant’s arguments have been considered but are unpersuasive. Applicant argues that the claim is integrated into a practical application because the claimed apparatus provides a technical solution of generating and monitoring resistivity profiles to detect migration without medical imaging. MPEP 2106.04(d)(1) states that a practical application may be present where the claimed invention improves another technology. See also MPEP 2106.05(a)(II). The problem of lead migration has troubled implanted medical devices since conception of their technology and tracking these movements is a problem that has existed as a training problem for healthcare professionals regardless of whether the electrodes were involved in the process. Applicant’s programming that determines migration is limited to the programming of the stimulation leads, rather than an improvement in the implanted leads. The programming improves healthcare provider workflows for migration management, but it does not address lead migration through a technological improvements. Any improvements are solely directed towards the abstract idea of mental process. Applicant’s claim is also confined to a known delivery devices (see Spec. Para. [0004]) and does not recite “another technology.” Applicant’s claimed invention recites the additional elements of delivery devices. There is no indication that these additional elements operate in a manner different than they normally operate. The specification discloses “delivery devices that treat a patient and/or record patient data are known” (par. 4). Operating another device in the manner it normally operates is insufficient to improve that other technology. As such, these additional elements are not improved through implementation of the abstract idea and a practical application is not present.
Regarding page 17, Applicant’s arguments have been considered but are unpersuasive. Applicant argues that the claim recites additional elements that include specialized medical hardware including a delivery device with first and second leads. Alongside Applicant’s previous comment regarding known delivery devices, Applicant also indicates the routine nature of these devices in [0004] with “implants and other delivery devices that deliver energy such as electrical energy, or deliver agents such as pharmaceutical agents are commercially available”. Applicant does not indicate how these delivery devices are specialized in the arguments. The additional elements of a delivery device and electrode implants were found to represent extra-solution activity were analyzed and determined to represent well-understood, routine, conventional activities in the field. As such, when viewed either individually or as an ordered combination, the additional elements do not provide significantly more to the abstract idea and the claims are not subject matter eligible.
Regarding page 18 and 19, Applicant’s arguments have been considered but are unpersuasive. Applicant argues that Wingeier fails to disclose a first and second resistivity profile to monitor lead migration because the resistivity information is an input parameter and does not disclose a resistivity profile. MPEP 2111 indicates that the broadest reasonable interpretation must be given to claim language in light of the specification. Figure 4 of Wingeier depicts a closed loop feedback loop for computing a fitness value for an electrode using impedance to dynamically optimize impedance estimates/measurements to predict impedances for each member. Furthermore, [0038] indicates that “quantitative characteristics of these models, such as tissue resistance per unit distance, can also be treated as input parameters to the model and optimized by routine 400” where optimizing the resistivity to produce a model comprises a resistivity profile. Tissue resistance/ distance is the same equation as Applicant’s derivation of a resistivity profile (see Applicant’s spec, [0163]). This system contains real-time adjustments based on measured distances alongside resistivity information. Therefore, the disclosure of Wingeier teaches generating the claimed resistivity profiles for the purpose of then using said resistivity profile in the disclosed model. This is distinct from Applicant’s interpretation of the prior art merely reciting input parameters to display as an output. Examiner interprets Wingeier to teach Applicant generating resistivity profiles and monitoring migration of leads, as amended.
Claim Rejections - 35 USC § 112(b)
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 67 is 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.
In line 2 of claim 67, the limitation of “the manufacturing” lacks sufficient antecedent basis. To overcome the rejection, amend the limitation to --manufacturing--.
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 58-65, 66-67, and 73-81 rejected under 35 USC 101 because the claimed invention is directed to a judicial exception, specifically abstract idea (determining position information based on measured impedances between the pairs of electrodes that best fit the mathematical model), without significantly more.
Step 1
The claimed invention in claim 58 is directed to statutory subject matter as the claims recite a medical apparatus for determining position information based on measured impedances between the pairs of electrodes that best fit the mathematical model.
Step 2A, Prong 1
Regarding claim 58, the recited steps are directed to mathematical concepts and mental process of performing concepts in a human mind or by a human using a pen and paper (see MPEP 2106.04(a)(2) subsections (I) and (III)).
In lines 10-14 of claim 58, the limitation of “a memory operatively coupled to the processor and storing: instructions for the processor to determine position information of the first lead and/or the second lead based on the measured impedances, a mathematical model; and a list of pairs of electrodes selected from the plurality of electrodes” is both a mathematical concept (see mathematical model in the claim limitation) and a mental process, as drafted, covering performance of the limitations that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, this limitation is nothing more than a medical professional memorizing how to determine position information of the first and/or second leads, a math model, and a list of electrode pairs.
Additionally, in lines 15-17 of claim 58, the limitation of “wherein the instructions for the processor determines the position information based on measured impedances between the pairs of electrodes that best fit the mathematical model” is both a mental process and a mathematical calculation. This limitation is process that can be performed by a human mind under the broadest reasonable standard and a mathematical calculation of fitting measured impedances to a polynomial spline curve to the resistivity, impedance, and distance values to determine position information (see Applicant, par. [0169]). For example, this limitation is nothing more than a medical professional determining position information based on analyzing measured impedance with respect to a mathematical model using pen and paper.
Furthermore, in lines 18-25, “wherein the instructions further comprise instructions to determine migration of one or both of the first or second leads by: generating a first resistivity profile of tissue surrounding the first lead based on a first set of impedances measured between one or more electrode pairs on the first lead; generating a second resistivity profile of tissue surrounding the second lead based on a second set of impedances measured between one or more electrode pairs on the second lead” is both a mental process and a mathematical calculation. This limitation is process that can be performed by a human mind under the broadest reasonable standard and a mathematical calculation of fitting measured impedances to a polynomial spline curve to the resistivity, impedance, and distance values to determine position information (see Applicant, par. [0169]). For example, this limitation is nothing more than a medical professional generating position information based on analyzing measured impedance with respect to a mathematical model using pen and paper.
Finally, in lines 26-27, “monitoring migration of one or both of the first or second leads by comparing the first and second resistivity profiles over time.” is both a mental process and a mathematical calculation. This limitation is process that can be performed by a human mind under the broadest reasonable standard and a mathematical calculation of fitting measured impedances to a mathematical model to determine position information. For example, this limitation is nothing more than a medical professional monitoring position information based on analyzing measured impedance with respect to a mathematical model using pen and paper.
Step 2A, Prong 2
For claim 58, the judicial exception is not integrated into a practical application.
In particular, lines 2-8 of claim 58 recite the additional element of “a delivery device comprising: a plurality of electrodes ; a first lead comprising a first set of the plurality of electrodes; and a second lead comprising a second set of the plurality of electrodes, wherein the delivery device is configured to measure impedance between pairs the plurality of electrodes”. This limitation amounts to no more than mere pre-solution activity of impedance data gathering using a delivery device.
Moreover, line 10 of claim 58 recites additional elements of “a processor operatively coupled to the delivery device.” The processor is recited at a high-level of generality and amount to nothing more than mere parts of a generic computer. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into practical application.
Step 2B
The claim does 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 abstract idea into a practical application, the additional elements of measuring impedance data amounts to no more than mere pre-solution activity of data gathering, which does not amount to an inventive concept.
Simply appending structures associated with well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception does not amount to an inventive concept. Furthermore, Applicant’s own specification describes “delivery devices that treat a patient and/or record patient data are known” (par. 4).
Furthermore, using components of a generic computer to perform generic computer functions, such as processing data, also does not amount to an inventive concept. (See MPEP § 2106.05(d)). In this case, elements of general computer are being used to implement abstract idea of determining position information based on measured impedances between the pairs of electrodes that best fit the mathematical model.
Regarding dependent claims 59-65, 66-67, and 73-81, the limitations of the dependent claims further define limitations of claim 58, which is already indicated as being directed to abstract idea.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 58-62, 64, 66, 73-81 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wingeier (US 2013/0096642 A1).
Regarding claim 58, Wingeier teaches a medical apparatus for a patient (See par. [0015] of Wingeier.), comprising;
a delivery device (In Fig. 1A of Wingeier, signal delivery system 110) comprising:
a plurality of electrodes configured to deliver stimulation energy to the patient (“an implanted stimulation system includes two leads” [0016]; see also in Fig. 2 of Wingeier, contacts 126a-h; see also “the pulse generator applies electrical pulses to the electrodes” [0006])
a first lead (In Fig. 2 of Wingeier, lead 112) comprising a first set of the plurality of electrodes; and (“an implanted stimulation system includes two leads” [0016])
a second lead (In Fig. 2 of Wingeier, lead 212) comprising a second set of the plurality of electrodes, (see also in Fig. 2 of Wingeier, contacts 126a-h) wherein the delivery device is configured to measure impedance between pairs of the plurality of electrodes (“At block 403, the routine 400 selects an initial parameter or set of parameters, e.g., r=0.2 centimeters; ζ=φ=θ=0; and Rj equal to measured or detected one-to-many-contacts impedance values, e.g., for each contact j” (Wingeier, Fig. 4, par. [0035]). Sentence 1 of par. [0042] further teaches obtaining values related to “measured impedance pair.”);
a processor operatively coupled to the delivery device; and (In Fig. 1A of Wingeier, one or more processors 122)
a memory operatively coupled to the processor and storing: (In Fig. 1A of Wingeier, memories or other storage devices 123)
instructions for the processor to determine position information of one or both of the first or second leads based on the measured impedances (“a routine 400 that the disclosed technology may invoke in various embodiments, e.g., to identify a position of a second lead relative to a first lead” (Wingeier, Fig. 4, par. [0034]), and “using routine 400 to determine relative lead positions for each new set of impedance measurements” (Wingeier, Fig. 4, par. [0047]).);
a mathematical model (“At block 404, the routine 400 employs a model (e.g., a “forward model” 300), e.g., to predict the expected impedances based on a set of parameters supplied to the forward model” (Wingeier, Fig. 4, par. [0036]).); and
a list of pairs of electrodes selected from the plurality of electrodes (“The forward model also takes as parameters impedance parameters Rj, e.g., for each contact j of leads 112 and 212. When each lead has eight contacts, j can take on values 1 through 16 and so there would be sixteen impedance values” (Wingeier, Fig. 4, par. [0036]).);
wherein the processor is configured to execute the instructions to determine the position information based on the measured impedances between the pairs of electrodes that best fit the mathematical model (“At decision block 410, routine 400 may determine whether an optimal fitness value has been computed” (Wingeier, Fig. 4, par. [0044]). “If an optimal fitness value has been computed, the routine continues at block 412. Otherwise, the routine continues at block 413” (Wingeier, Fig. 4, par. [0044]).).
and wherein the instructions further comprise instructions to determine migration of one or both of the first or second leads by: (“The model can take as input various parameters, e.g., geometric parameters such as distances between the two leads at various points, rotation about axes, etc; various physical parameters such as resistivity or specific impedance of nearby tissue; and parameters representing impedance values at each contact” (Wingeier, par. [0016])
generating a first resistivity profile of tissue surrounding the first lead based on a first set of impedances measured between one or more electrode pairs on the first lead; ( “Quantitative characteristics of these models, such as tissue resistance per unit distance, can also be treated as input parameters to the model and optimized by routine 400” (Wingeier, par. [0038]; see also “When each lead has eight contacts, j can take on values 1 through 16 …. The impedance parameters can indicate the electrode-tissue impedance at each contact. The impedance parameters Rj may represent the actual electrode-tissue impedance specific to the contact” (Wingeier, par. [0036]. The description of (par. [0016] and [0036]) Wingeier implies the model positively includes resistivity/impedance information regarding the tissue surrounding the leads.
generating a second resistivity profile of tissue surrounding the second lead based on a second set of impedances measured between one or more electrode pairs on the second lead; (“The technology may employ more complex or less complex models of electrode-tissue interface impedance and tissue impedance between two electrical contacts. These more complex or less complex models may include characteristics of the electrode-tissue interface impedance and medium impedance such as linearity, nonlinearity, isotropy, anisotropy, or frequency-dependence, other structures affecting impedance such as vertebrae or spinal tissue” (Wingeier, par. [0038]). Wingeier directly implies that the impedance of tissues along the path between the two electrodes would be a factor in the model.);
and monitoring migration of one or both of the first or second leads by comparing the first and second resistivity profiles over time. (“routine 400 can indicate the relative positions of the leads or contacts, … in nearly ‘real-time’ so that the changed positions are evident immediately, e.g., by repeatedly measuring or detecting new impedance measurements, and repeatedly using routine 400 to determine relative lead positions for each new set of impedance measurements” in par. [0047] indicates a continuous monitoring of lead migration over time for each lead; see also “the user interface 600 may enable users (e.g., practitioners) to … record movement of leads,” [0054])
Regarding claim 58, Wingeier discloses measuring impedances between electrode pairs on each lead and modeling tissue impedance across distance, similar to Applicant’s specification in [0163]. Wingeier does not expressly derive a resistivity profile from the measured impedances. Wingeier expressly models the impedance between any two contacts j and k [see 0037] and further teaches that “tissue resistance per unit distance” is optimized by routine 400 against the measured impedances [0038]. The distance term in a volume conductor is given by the standard spreading-resistance relation f(d)= ρ/4πd [i.e., Z= ρk, where k is the geometric constant, and ρ is resistivity]. Therefore, it would have been prima facie obvious to a person having ordinary skill in the art, before the effective filing date, to have applied Wingeier’s impedance and distance measurements to account for any applicable tissue medium and coordinate system so as to accurately derive a resistivity profile. Applying this would have amounted to no more than a routine application of a known mathematical relationship yielding predictable results.
Regarding claim 59, Wingeier teaches the invention of claim 58, and further teaches wherein the position information comprises angular rotation information of one or both of the first lead or the second lead (See the description of theta 304 and phi 303 in par. [0033] of Wingeier.)
Regarding claim 60, Wingeier teaches the invention of claim 59, and further teaches wherein the position information comprises angular rotation information of the first lead and the second lead (See the description of theta 304 and phi 303 in par. [0033] of Wingeier.).
Regarding claim 61, Wingeier teaches the invention of claim 58, and further teaches wherein the position information comprises the position of one or both of the first lead or the second lead relative to the patient’s anatomy (“In some embodiments, parameters describing the position of leads with respect to these anatomical structures may be included in the forward model and optimization process, yielding a determination of position with respect to these structures in addition to a determination of relative lead position” (Wingeier, par. [0058]).).
Regarding claim 62, Wingeier teaches the invention of claim 58, and further teaches wherein the position information comprises a position of the first lead relative to the position of a second lead (“The orientation of lead 212 may also be compared relative to lead 112 in one or more rotational axes” (Wingeier, Fig. 3, par. [0033]).).
Regarding claim 64, Wingeier teaches the invention of claim 58, and further teaches wherein the position information comprises a position of the first lead relative to the second lead at a first instance in time as compared to a position of the first lead relative to the second lead at a second instance in time, and wherein the second instance of time is before the first instance in time
(“At block 403, the routine 400 selects an initial parameter or set of parameters, e.g., r=0.2 centimeters; z=.PHI.=.theta.=0; and Rj equal to measured or detected one-to-many-contacts impedance values, e.g., for each contact j” (Wingeier, par. [0035]).
At block 404, “the forward model takes as parameters r, z, .PHI., and .theta. that can be used to specify the position of a second lead relative to a first lead” (Wingeier, par. [0036]).
At block 408, “The technology can compute a fitness value that compares the output of the model [or a set of predicted impedance measurements] with actually detected impedance values” (Wingeier, par. [0016]).).
Regarding claim 66, Wingeier teaches the invention of claim 58, and further teaches wherein the instructions for the processor to determine the position information is based on data gathered prior to implantation of the delivery device in the patient (“During at least some procedures, an external programmer 120 (e.g., a trial modulator) can be coupled to the signal delivery device 111 during an initial procedure, prior to implanting the pulse generator/receiver 121” (Wingeier, par. [0023]). “The practitioner can test the efficacy of the signal delivery device 111 in an initial position …. The practitioner can then disconnect the cable assembly 114 (e.g., at a connector 117), reposition the signal delivery device 111, and reapply the electrical modulation. This process can be performed iteratively until the practitioner obtains the desired position for the signal delivery device 111” (Wingeier, par. [0023]).).
Regarding claim 73, Wingeier teaches the invention of claim 58 and further teaches wherein the impedances are measured between at least one pair of electrodes of the first set of electrodes and at least one pair of electrodes of the second set of electrodes, (“The model can take as input various parameters, e.g., geometric parameters such as distances between the two leads at various points, rotation about axes, etc; various physical parameters such as resistivity or specific impedance of nearby tissue; and parameters representing impedance values at each contact” (Wingeier, par. [0016]). And “When each lead has eight contacts, j can take on values 1 through 16 …. The impedance parameters can indicate the electrode-tissue impedance at each contact. The impedance parameters Rj may represent the actual electrode-tissue impedance specific to the contact” (Wingeier, par. [0036] “The technology may employ more complex or less complex models of electrode-tissue interface impedance and tissue impedance between two electrical contacts. These more complex or less complex models may include characteristics of the electrode-tissue interface impedance and medium impedance such as linearity, nonlinearity, isotropy, anisotropy, or frequency-dependence, other structures affecting impedance such as vertebrae or spinal tissue” (Wingeier, par. [0038]). “Quantitative characteristics of these models, such as tissue resistance per unit distance, can also be treated as input parameters to the model and optimized by routine 400” (Wingeier, par. [0038]).
This description of (of par. [0038] of) Wingeier directly implies that the impedance of tissues along the path between the two electrodes would be a factor in the model.);. The description of (par. [0016] and [0036] of) Wingeier implies the model positively includes resistivity/impedance information regarding the tissue surrounding the leads.
and wherein the instructions for the processor to determine the position information comprise instructions to determine a relative position between the first lead and the second lead by (“FIG. 4 is a flow diagram illustrating a routine 400 that the disclosed technology may invoke in various embodiments, e.g., to identify a position of a second lead relative to a first lead” (Wingeier, par. [0034]).):
measuring the impedance between at least one cross-lead pair of electrodes, each cross-lead pair comprising one electrode of the first set of electrodes and one electrode of the second set of electrodes (“The technology constructs a model (e.g., a "forward model") of the expected impedance measured between contacts of the two leads, e.g., between contact of a first lead and each contact of a second lead” (Wingeier, par. [0016]). “In some embodiments, the impedance between any two contacts j and k is assumed to be the sum of Rj, Rk, and a function f(distjk) of the Cartesian distance (dist) between the two contacts j and k. The technology can model impedance between one set of one or more contacts and another set of one or more contacts using well known rules for addition of resistances” (Wingeier, par. [0037]).Also see par. [0039], sentence 2 of Wingeier. These descriptions of Wingeier teach determining impedance between one pair and another pair.);
determining a distance between the at least one cross-lead pair of electrodes using a linear resistivity assumption based on the first and second resistivity profiles (“In various embodiments, the technology may employ more complex or less complex models of electrode-tissue interface impedance and tissue impedance between two electrical contacts. These more complex or less complex models may include characteristics of the electrode-tissue interface impedance and medium impedance such as linearity” (Wingeier, par. [0038]).
See par. [0045] regarding block 413 (vary parameters). In par. [0045], simulated metal technique is used to vary parameters such as parameter r until a “most fit” set of parameters can be ultimately identified that maximizes the fitness value. Note: “A parameter r 301 can indicate a radial distance (e.g., in cylindrical coordinates) between a specified contact on each lead, e.g., a least distal contact from a first end of each lead” (Wingeier, par. [0033]).); and
determining the relative positions between the first and second leads using the calculated distances (“If an optimal fitness value has been computed, the routine continues at block 412” (Wingeier, par. [0044]). “At block 412, routine 400 can indicate the relative positions of the leads or contacts, e.g., on a display” (Wingeier, par. [0047]).).
Regarding claim 74, Wingeier teaches the invention of claim 73, and further teaches wherein the at least one pair of electrodes of the first set of electrodes comprises all pairs of electrodes of the first set of electrodes, and wherein the at least one pair of electrodes of the second set of electrodes comprises all pairs of electrodes of the second set of electrodes
(“The technology constructs a model (e.g., a "forward model") of the expected impedance measured between contacts of the two leads, e.g., between contact of a first lead and each contact of a second lead” (Wingeier, par. [0016]).
At block 404, “these simulated impedance measurements may be selected to correspond with actual impedance measurements that have been collected; as an example, if an impedance measurement has been collected between each contact and the set of all other contacts, the forward model can be used to output simulated impedance measurements between each contact and the set of all other contacts” (Wingeier, par. [0039]).).
Regarding claim 75, Wingeier teaches the invention of claim 73, and further teaches wherein the impedance measurements include at least 56 impedance measurements per lead
(See the Wingeier teaching with regards to step a of claim 73. Additionally, Fig. 2 depicts eight contacts 126a-h on lead 112 and eight contacts 226a-h on lead 212.
Based on the description of Wingeier above, there would be at least 64 impedance measurements per lead.).
Regarding claim 76, Wingeier teaches the invention of claim 73, and further teaches wherein the at least one cross-lead pair of electrodes comprises at least 64 pairs of electrodes
(See the Wingeier teaching with regards to step a of claim 73. Additionally, Fig. 2 depicts eight contacts 126a-h on lead 112 and eight contacts 226a-h on lead 212.
Based on the description of Wingeier above, there would be 64 pairs of electrodes.).
Regarding claim 77, Wingeier teaches the invention of claim 73, and further teaches wherein the relative position includes a first linear offset Lx (In Fig. 3 of Wingeier, see parameter r 301), a second linear offset Ly (In Fig. 3 of Wingeier, see parameter z 302), and/or an angle
θ
(In Fig. 3 of Wingeier, see
θ
304) between the first lead and the second lead.
Regarding claim 81, Wingeier teaches the invention of claim 78, and further teaches wherein the migration of one or both of the first lead or second lead (“In various embodiments, the user interface 600 may enable users (e.g., practitioners) to…record movement of leads, etc.” (Wingeier, par. [0054]) comprises a linear migration of the first lead relative to the second lead, or of the second lead relative to the first lead (“These initial parameters may represent a lead position believed to be most likely; they may be based on previous lead position” [0035], where the current and previous lead positions comprise a linear migration. See also par. [0045] regarding block 413 (vary parameters). In par. [0045], simulated metal technique is used to vary parameters such as parameter r until a “most fit” set of parameters can be ultimately identified that maximizes the fitness value. Note: “A parameter r 301 can indicate a radial distance (e.g., in cylindrical coordinates) between a specified contact on each lead, e.g., a least distal contact from a first end of each lead” (Wingeier, par. [0033]).
See par. [0047] of Wingeier describing render changes in position of leads in nearly “real-time”.
Based on the description above, if parameter r 301 increases over time, the practitioner knows that the radial distance between specified contact on each lead is increasing linearly between one point to the next).
Regarding claim 90, Wingeier teaches the invention of claim 58. Wingeier also teaches wherein the instructions further comprise instructions to adjust one or more parameters of the stimulation energy based on the lead migration. (“The pulse generator/receiver 121 can … up-regulate (e.g., stimulate or excite) and/or down-regulate (e.g., block or suppress) target nerves… with instructions for generating and transmitting suitable therapy signals” Wingeier, par. [0021]) (“routine 400 can indicate the relative positions of the leads or contacts, … in nearly ‘real-time’ so that the changed positions are evident immediately, e.g., by repeatedly measuring or detecting new impedance measurements, and repeatedly using routine 400 to determine relative lead positions for each new set of impedance measurements” in par. [0047] indicates a continuous monitoring of lead migration over time for each lead for adjustment of parameters)
Regarding claim 91, Wingeier teaches the invention of claim 90. Wingeier also teaches wherein the parameters of the stimulation energy comprise one or more of: … drive impedance (“impedance parameters can indicate the electrode-tissue impedance at each contact” Wingeier, par. [0036]) … anode configuration, cathode configuration. (“coordinates used, to identify a position of a second lead relative to a first lead. Taking one end of lead 112 (or a contact of lead 112) as an origin in the coordinate system 300, a parameter z 302 can indicate a z-coordinate of a corresponding end of lead 212 (or a contact of lead 212)” Wingeier, par. [0033])
Claim(s) 63 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wingeier (US 2013/0096642 A1), as applied to claim 58, and further in view of Min et al. (US 2016/0157769 A1) (hereinafter “Min”).
Regarding claim 63, Wingeier teaches the invention of claim 58. However, Wingeier does not teach comparing position information of the first lead relative to the patient’s anatomy at first and second instance of time.
With regards to Fig. 1 of Min, “component 52 may be configured to generate lead position geometrical models, which illustrate a position of one or more electrodes on a lead with respect to a spinal cord (SC) tissue of interest based on measured impedance and evoked compound action potential (ECAP) signals” (Min, par. [0047]). Min further teaches wherein the position information comprises a position of the first lead relative to the patient’s anatomy at a first instance in time as compared to a position of the first lead relative to the patient’s anatomy at a second instance of time, and wherein the second instance in time is before the first instance in time
(“FIG. 8 is a graphical illustration 800 of the impedance signals 806-810 corresponding to drive signals originating or sensed from electrodes 511a-e, acquired at 304, at different points in time” (Min, par. [0081]).
“The magnitude of the impedance signal 806-810 corresponds to a distance (e.g., 702-710) from the emitting electrode (e.g., 511a-e) to the dura layer 514 or CSF 508” indicates location differences (Min, par. [0084]).
“The impedance signals 806-810 may be compared by the system 100 and/or the controller 251 to an impedance distance database to determine the distances 702-710” (Min, par. [0085]).).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the comparison of signals related to position at different times of Min in the invention of Wingeier in order to simplify the computational process and reduce the need for specialized personnel to perform the tasks such as assessing the placement of the NS system within the patient (Min, par. [0004]).
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Figure 8 of Min
Claim(s) 65 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wingeier (US 2013/0096642 A1), as applied to claim 58, and further in view of Bradley et al. (US 2006/0122653 A1 cited in IDS) (hereinafter “Bradley”).
Regarding claim 65, Wingeier teaches the invention of claim 58. Wingeier expressly teaches an external power source 118 and implantable pulse generator/receiver 121 in par. [0022]. However, Wingeier does not expressly a housing surrounding the power supply and the controller, and wherein the first lead and/or the second lead is attachable to the housing during a clinical procedure in which the delivery device is implanted in the patient.
Bradley teaches “the present invention uses: (1) interelectrode impedance (one technique or embodiment) … to determine the relative orientation of one electrode on an implanted lead to other electrodes on the implanted lead or adjacent implanted leads in the spinal column or other body/tissue location” (Bradley, par. [0024]). Bradley further teaches wherein the delivery device (In Fig. 1 of Bradley, see leads 20, 30 and IPG 40.) further comprises a power supply (“the IPG 40 therein depicted is made up of a multiplicity of dual current sources 42” (Bradley, par. [0029).), a controller (“A programmable current control circuit 44 is also provided within the IPG 40” (Bradley, par. [0032]).), and a housing (See the outer cover of IPG 40 in Fig. 1 of Bradley.) surrounding the power supply and the controller, and wherein one or both of the first lead or the second lead is attachable to the housing during a clinical procedure in which the delivery device is implanted in the patient (“Each of the electrodes of each lead 20 or 30 are electrically connected through respective wires, embedded or carried within a body of the lead, to an implantable pulse generator (IPG) 40” (Bradley, par. [0026]). Since IPG 40 is an abbreviation of implantable pulse generator 40, it can be inferred that IPG 40 can be implanted in the body. Additionally, par. [0024] discusses implanting leads in the body.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the neurostimulation system of Bradley in the invention of Wingeier in order to have a more objective technique for verifying the position of the leads (Bradley, par. [0005]) and prevent electrical reprogramming or surgical revision (Bradley, par. [0004]).
Claim(s) 67 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wingeier (US 2013/0096642 A1), as applied to claim 66, and further in view of Riahi et al. (US 2020/0132434 A1 filed 10/29/2019) (hereinafter “Riahi”).
Regarding claim 67, Wingeier teaches the invention of claim 66. See the 35 USC 112(b) rejection(s) directed to this claim. Wingeier does not adequately teach wherein the data is gathered during manufacturing of the delivery device.
Riahi teaches estimating an offset between a first group and a second group of contacts with respect to a longitudinal direction using impedance data (Riahi, Abstract). Riahi further teaches wherein the data is gathered during the manufacturing of the delivery device (‘pre-conditioning of the measured data set comprises using the distribution of measurements to subtract estimations of electrode-specific characteristics “ [0030] and “a lead with 3-mm long electrodes separated by 4 mm of insulating material (=inter-electrode space)” (Riahi, par. [0037]) and stored in the memory (” templates are generated beforehand and they can be stored in a device ROM saving working memory.” [0140]). Based on the description, the separation distance between each two adjacent electrodes is known.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to preconfigure the known adjacent electrode separation distance stored in memory of Riahi’s system in the invention of Wingeier in order to “remotely determine the relative position of the electrode leads with respect to one another while particularly avoiding excessive use of the system's memory and significant reduction of battery life, and particularly without requiring the patient to undergo medical imaging” (Riahi, par. [0010]).
Conclusion
The prior art made of record and not relied upon that is considered pertinent to applicant’s disclosure can be found on PTO-892 of the prior office action.
DaShazo et al. (Pat. 11135439) measures multiple voltage points during a therapy pulse and uses those time-based measurements to estimate an impedance model of the electrode/tissue interface. That richer model lets the implantable device monitor electrode condition, patient changes, and therapy loading more accurately than a single-point resistance check.
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/R.A.S/Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792
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