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 .
In the claims 58-59, 61, 65, 77-78, every instance of “and/or” will be interpreted as or.
Election/Restrictions
Applicant's election with traverse in the reply filed on 10/03/2024 is acknowledged. The traversal is on the ground(s) that species (b) and (c) containing overlapping subject matter and species (e) is not a species of an algorithm used for determining location of leads. This is found persuasive.
Claims 68-72 and 82-89 are withdrawn.
Claims 58-65, 66-67, and 73-81 will be examined on the merits.
Priority
The effective filing date of the claimed invention is 12/23/2019.
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.
Specification Objection
The use of the term Bluetooth, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claims 58 and 63-64 are objected to because of the following informalities:
In line 1 of claim 58, for correct punctuation, the semi-colon should instead be a colon.
In line 4 of claims 63-64, for maintaining consistency, “first instance in time” should read as --first instance of time--.
Appropriate correction is required.
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, 73-81 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.
In line 2 of claim 67, the limitation of “the manufacturing” lacks sufficient antecedent basis. To overcome the rejection, amend the limitation to --manufacturing--.
In claim 67, the limitation of “wherein the data is gathered during the manufacturing of the delivery device” is indefinite. It is unclear how this limitation ties into independent claim 58. It is unclear how the data gathered is communicated to the processor and memory. When looking to the specification, the Applicant comes close to providing an explanation in par. [0157] and par. [0162]: “for each measurement, the associated separation distance between each two adjacent electrodes 2600 is known (e.g. as determined by the manufacture of each lead 265).” However, there still is not adequate clarity.
In line 12 of claim 73, the limitation of “the distance” lacks sufficient antecedent basis. To overcome the rejection, amend the limitation to --distance--.
In line 3 of claim 78, the limitation of “the relative positions” lacks sufficient antecedent basis. To overcome the rejection, amend the limitation to --relative positions--.
In line 11 of claim 78, the limitation of “the difference” lacks sufficient antecedent basis. To overcome the rejection, amend the limitation to --a difference--.
In line 2 of claim 81, the phrase “relative linear” renders the limitation of “a relative linear migration” indefinite. The phrase “relative linear” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear the degree to which migration between the first lead and second lead can be considered linear.
Dependent claims 74-77 are rejected by virtue of their dependency on claim 73.
Dependent claims 79-81 are rejected by virtue of their dependency on claim 78.
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 claim(s) recite(s) 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 memorize how to determine position information of the first and/or second leads, a math model, and a list of electrode pairs.
Furthermore, 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 mathematical model to determine position information. 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.
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 comprising a first set of electrodes comprising one or more electrodes, and a second set of electrodes comprising one or more electrodes; a first lead comprising the first set of electrodes; and a second lead comprising the second set of electrodes, wherein the delivery device is configured to measure impedance between multiple pairs of electrodes of 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.
Claim(s) 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 comprising a first set of electrodes (In Fig. 2 of Wingeier, contacts 126a-h) comprising one or more electrodes, and a second set of electrodes (In Fig. 2 of Wingeier, contacts 226a-h) comprising one or more electrodes;
a first lead (In Fig. 2 of Wingeier, lead 112) comprising the first set of electrodes; and
a second lead (In Fig. 2 of Wingeier, lead 212) comprising the second set of electrodes, wherein the delivery device is configured to measure impedance between multiple pairs of electrodes 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; z=.PHI.=.theta.=0; and R.sub.j 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 (In Fig. 1A of Wingeier, one or more processors 122) operatively coupled to the delivery device; and
a memory (In Fig. 1A of Wingeier, memories or other storage devices 123) 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 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 R.sub.j, 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 instructions for the processor determines the position information based on 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]).).
Regarding claim 59, Wingeier teaches the invention of claim 58, and further teaches wherein the position information comprises angular rotation information of the first lead and/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 the first lead and/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 the position of the first lead relative to the position of the 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 the position of the first lead relative to the second lead at a first instance of time as compared to the position of the first lead relative to the second lead at a second instance of time, and wherein the second instance of time is previous to 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 R.sub.j 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 instructions for the processor to determine the position information comprises 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 pair of electrodes of the first set of electrodes and at least one pair 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]).
“In some embodiments, the impedance between any two contacts j and k is assumed to be the sum of R.sub.j, R.sub.k, and a function f(dist.sub.jk) 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.);
creating a first resistivity profile of tissue surrounding the first lead and creating a second resistivity profile of tissue surrounding the second lead based on the impedance measurements
(“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]).
“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 R.sub.j may represent the actual electrode-tissue impedance specific to the contact” (Wingeier, par. [0036]).
The description of (par. [0016] and [0036] of) Wingeier implies the model positively includes resistivity/impedance information regarding the tissue surrounding the leads.
“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.);
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 (See the Wingeier teaching with regards to step a of claim 73.);
determining the distance between the at least one cross-lead pair of electrodes using a linear resistivity assumption based on the first resistivity profile and the second resistivity profile
(“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 of the first lead and the second lead 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 78, Wingeier teaches the invention of claim 58, and further teaches wherein the instructions for the processor further comprise instructions to characterize a migration of the first lead and/or the second lead by:
determining the relative positions of the first lead and the second lead at a first time T1;
creating an initial graph based on the relative positions at the first time T1;
determining the relative positions of the first lead and the second lead at a second time T2;
creating a subsequent graph based on the relative positions at the second time T2; and
determining the difference between the initial graph and the subsequent graph to determine the migration of the first lead and/or the second lead between the first time T1 and the second time T2.
(“At block 412, routine 400 can indicate the relative positions of the leads or contacts, e.g., on a display. As an example, the technology may render (e.g., display or draw) a graphical depiction of one or both leads on a display so that the practitioner can visually see how the second lead is positioned relative to the first lead, e.g., on a display device. The technology can render changes in position 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” (Wingeier, par. [0047]).
“In various embodiments, the user interface 600 may enable users (e.g., practitioners) to…record movement of leads, etc.” (Wingeier, par. [0054]).
Based on the description, the lead positions are recorded and displayed on graphs. These graphs are updated with repeated measuring and can indicate lead movement if the relative lead positions change.).
Regarding claim 79, Wingeier teaches the invention of claim 78, and further teaches wherein the relative positions of the first lead and the second lead are determined using a resistivity profile
(“At block 404, the routine 400 employs a model (e.g., a "forward model" 300)” (Wingeier, par. [0036]), and “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]).
“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]).
“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 R.sub.j may represent the actual electrode-tissue impedance specific to the contact” (Wingeier, par. [0036]).
“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]).).
Regarding claim 80, Wingeier teaches the invention of claim 78, and further teaches wherein the relative positions of the first lead and the second lead are determined using impedance measurements (“Using routine 400 to determine relative lead positions for each new set of impedance measurements” (Wingeier, par. [0047]).).
Regarding claim 81, Wingeier teaches the invention of claim 78, and further teaches wherein the migration of the first lead and the second lead comprises a relative linear migration between the first lead and the second lead
(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]).
See par. [0047] of Wingeier describing render changes in position of leads in nearly “real-time”.
“In various embodiments, the user interface 600 may enable users (e.g., practitioners) to…record movement of leads, etc.” (Wingeier, par. [0054]).
Based on the description above, if parameter r 301 increases over time, the practitioner knows that the radial distance between a specified contact on each lead is increasing.).
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 the position of the first lead relative to the patient’s anatomy at a first instance of time as compared to the position of the first lead relative to the patient’s anatomy at a second instance of time, and wherein the second instance of time is previous to 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” (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 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 (“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 the 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 (“a lead with 3-mm long electrodes separated by 4 mm of insulating material (=inter-electrode space)” (Riahi, par. [0037]). 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 include the known adjacent electrode separation distance of Riahi 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]).
Prior Art of Record
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Engelman et al. (US 20140018788 A1) (hereinafter “Engelman”) teaches arms 66 and 67 in Fig. 6B. On arm 66, “electrode element 68 may be configured as an electrode” (Engelman, par. [0141]), and on arm 67, “ablation element 69 may be configured as an electrode” (Engelman, par. [0141]). Engelman also teaches the following:
“Tissue impedance … may be measured between electrodes on each arm” (par. [0316]);
“Impedance measurement across an intercarotid septum may be used to indicate distance between electrodes” (par. [0316]);
“For example, a bipolar radiofrequency configuration may provide an improved signal to noise ration compared to a monopolar configuration and may provide a clear indication that electrodes are moving” (par. [0316]); and
“if electrode contact with tissue is compromised or electrode position has moved[,] an acute impedance change and simultaneous temperature change at one or both electrodes may be measured” (par. [0316]).
Conclusion
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/P.M./Examiner, Art Unit 3792
/JAMES M KISH/Supervisory Patent Examiner, Art Unit 3792
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