Detailed Action
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
The rejections made under 35 U.S.C. 112(b) and 101 are withdrawn.
Applicant’s arguments with respect to rejections of claims 1-20 under 35 U.S.C. 102 and 103 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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On page 8 of Remarks, Applicant argues
Examiner asserts claim 16 still does not further limit dependent claim 12. For example, claim 16 has been amended to include “wherein the anatomical region comprises a target anatomical element”. Claim 1 already recites “receive a first image of an anatomical region, wherein the first image depicts an anatomical element”. Under the broadest reasonable interpretation for claim 1, the anatomical region comprises an anatomical element, as the first image is of the anatomical region and depicts an anatomical element. Furthermore, the use of “target” does not provide any meaningful limits to the claim which would constitute a further limitation of claim 12. Therefore, the rejection made under 35 U.S.C. 112(d) for claim 4 is maintained.
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On pages 8 and 9 of Remarks, Applicant argues
Examiner agrees that amended claim 1, as drafted, overcomes the previous 35 U.S.C. 101 rejection. The claim recites specific steps tied to a particular technological process, including generating updated implanted lead parameters for providing stimulation to an anatomical element by processing and comparing images of temporary implanted leads and subsequent implanted leads after a test period. Thus, these recited limitations integrate the judicial exception into a practical application by reciting an improvement to the technology field (see specifications paragraph 0049).
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 16-19 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 16 recites “process the first image to identify the target anatomical element and the initial lead; and process the second image to identify the target anatomical element and the implanted lead”, which is indefinite. These claim limitations are substantially identical to the processing steps recited in lines 9 and 16-17 of claim 12, with the mere addition of the term “target”. It is unclear whether the limitations are meant to define a separate processing of the first image and second image or if they are meant to further limit the corresponding limitations of claim 1. Thus, one of ordinary skill the art would not be able to ascertain the scope of the claim. For examination purposes, the claim limitations will be interpreted as requiring the same processing of the first and second images as recited in claim 1.
Claims 17-19 are rejected as being dependent on a rejected base claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 16 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 16 recites “process the first image to identify the target anatomical element and the initial lead; and process the second image to identify the target anatomical element and the implanted lead.”, which, under the 112(b) interpretation outline above, contains element found analogous to the limitations in lines 9 and 16-17 of independent claim 12. Claim 16 further recites “wherein the anatomical region comprises a target anatomical element”, which, as discussed above in Response to Arguments, contains element found analogous to the limitations in lines 5-6 of claim 1. Thus, claim 16, which depends from claim 12, does not further limit claim 12 and is being rejected under 35 U.S.C. 112(d).
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-8, 10-14, and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Goetz et al. (US 9259589 B2), (hereinafter Goetz) in view of Lee et al. (US 20220080212 A1), (hereinafter Lee).
Regarding claim 1, A system for generating a lead parameter, comprising:
a pulse generator configured to generate an electrical signal; an implanted lead in communication with the pulse generator and configured to transmit the electrical signal to an anatomical element (Goetz, “Implantable electrode arrays may be used to deliver therapy to patients to treat a variety of symptoms or conditions such as chronic pain, tremor, Parkinson's disease, epilepsy, urinary or fecal incontinence, sexual dysfunction, obesity, or gastroparesis. For example, an implantable medical device may deliver neurostimulation therapy via leads that include electrodes located proximate to the spinal cord, pelvic nerves, peripheral nerves, the stomach or other gastrointestinal organs, or within the brain of a patient. In general, the implantable medical device may deliver electrical stimulation therapy in the form of electrical pulses via one or more electrodes carried by one or more implantable leads.”, column 1, lines 21-32, see Fig. 1, implantable stimulator 14 and implanted leads 16A-16B);
a processor; and a memory storing data for processing by the processor (Goetz, “In a further embodiment, the disclosure provides a computer-readable medium comprising instructions to cause a processor to analyze an electronic image of an electrical stimulation electrode array implanted within a patient to identify one or more physical characteristics of the electrode array”, column 2, lines 52-57, see Fig. 2, processor 24), the data, when processed, causes the processor to:
receive a first image of an anatomical region, wherein the first image depicts the anatomical element and at least a portion of an initial lead (Goetz, “In operation, following implantation of one or more leads within a patient to form a lead configuration, a caregiver may obtain a post-implantation image of the lead configuration within the patient using any of a various imaging modalities…”, column 7, lines 17-20, “Using post-implant imagery, the implanted leads may be characterized to identify the type or types of leads implanted within a patient and/or determine positions of the implanted leads and/or electrodes carried by the leads relative to one another and/or or relative to anatomical structures within the patient.”, column 8, lines 52-57);
receive an initial lead parameter associated with the initial lead (Goetz, “An image processing device analyzes the image to identify one or more physical characteristics of the lead or leads in the lead configuration… A user may rely on the characterization information to manually adjust various electrical stimulation parameters. Alternatively, or additionally, an automatic or guided programming algorithm may rely on the information to automatically adjust various electrical stimulation parameters. Adjustment of stimulation parameters may refer to initial setting of parameters or modification of existing parameters.”, column 7, lines 35-51, Patient images are obtained for implanted lead identification. This includes determining characterization information for the leads, and using this to adjust or set Initial lead parameters.);
receive a second image of the anatomical region depicting at least a portion of the anatomical element and at least a portion of the implanted lead; generate an implanted lead parameter for the implanted lead based on a combination of the initial lead parameter and a correlation of the first image with the second image; and control the pulse generator to stimulate the anatomical element based on the implanted lead parameter (Goetz, “In addition to specifying lead configuration and parameters, programmer 20 may be configured to accept updated lead characterization data at a later time in order to accommodate possible lead migration. For example, at some time after initial implantation, e.g., days, months or years, a patient may return to the clinic to permit imaging modality 50 to obtain one or more subsequent electronic images of the implanted lead configuration. Image processing device 52 then may analyze the subsequent electronic image or images (100), and automatically generate an updated lead characterization (102) based on the analysis of the subsequent electronic image.”, column 28, lines 43-54, “As an additional or alternative purpose, relative spacing between electrodes in the lead configuration may be used to detect lead migration over time. For example, lead characteristics such as relative spacing of electrodes may be obtained from different images taken at different times, and then compared to determine whether one or more of the electrodes has shifted relative to a previous position… Using migration information, such as relative spacing differences, programmer 20, may automatically adjust or propose adjustments to one or more stimulation parameters, e.g., in a manner similar to that described above.”, columns 44 and 45, lines 51-67 and 1-3, respectively, The initial lead parameters can be adjusted based on subsequent imaging. Lead migration is determined by comparing patient images from different times, and this information is used to update parameter settings for lead stimulation.).
Goetz does not teach an initial lead temporarily implanted into the anatomical region for a duration of a test period during which the anatomical element is stimulated via the initial lead; an initial lead parameter generated based on the stimulation of the anatomical element via the initial lead during the test period; and receive, after the test period and after the initial lead is replaced by the implanted lead in the anatomical region, a second image of the anatomical region.
However, Lee teaches an initial lead temporarily implanted into the anatomical region for a duration of a test period during which the anatomical element is stimulated via the initial lead; an initial lead parameter generated based on the stimulation of the anatomical element via the initial lead during the test period; and receive, after the test period and after the initial lead is replaced by the implanted lead in the anatomical region, a second image of the anatomical region (Lee, “FIG . 1 schematically illustrates a use of a trial neurostimulation system utilizing an EPG affixation device, in accordance with aspect of the invention. Such a trial neurostimulation system can be used to assess viability of a fully implantable neurostimulation system .”, pg. 3, paragraph 0044, lines 1-5, “In a conventional approach, prior to implantation of the permanent device , patients undergo an initial testing phase to estimate potential response to treatment. The first type of testing developed was percutaneous nerve evaluation (PNE). This procedure is done under local anesthesia , using a test needle to identify the appropriate sacral nerve (s). Once identified, a temporary wire lead is inserted through the test needle and left in place for 4 to 7 days. This lead is connected to an external stimulator , which can be carried by patients in their pocket , secured against the skin under surgical dressings , or worn in a belt. The results of this test phase are used to determine whether patients are appropriate candidates for the permanent implanted device.”, pg. 4, paragraph 0050, lines 1-13, “FIG . 15 illustrates a schematic of a trial system 100 , in accordance with aspect of the invention , and a permanent system 200 to further demonstrate the applicable uses of any of the neurostimulation leads described herein. As can be seen, each of the trial and permanent system are compatible for use with a wireless clinician programmer and a patient remote. The communication unit by which EPG wirelessly communicates with the clinician programmer and patient remote can utilize MedRadio or Bluetooth capability, which can provide a communication range of about two meters . The clinician programmer can be used in lead placement, programming and stimulation control in each of the trial and permanent systems. In addition, each allows the patient to control stimulation or monitor battery status with the patient remote. This configuration is advantageous as it allows for an almost seamless transition between the trial system and the permanent system.”, pg. 10, paragraph 0094, lines 1-17, see Fig. 15).
Goetz teaches updating lead stimulation parameters by analyzing post-implant images to account for lead migration over time (Goetz, column 28, lines 43-54 and columns 44 and 45, lines 51-67 and 1-3, respectively). Goetz does not teach implementing a test period where a temporary lead is implanted. Lee teaches a trial neurostimulation system for an evaluation period, which uses a temporary implanted lead that is later replaced by a permanently implanted lead (see above). Lee further teaches using the same clinician programmer for lead placement, programming, and stimulation control to transition from trail to permanent implantations (Lee, paragraph 0094). Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified the lead parameter updating of Goetz to be applied to the transition from temporary to permanent implantation as taught by Lee (see paragraph 0050 and 0094). The motivation for doing so would have been to account for lead migration across implantations to maintain consistent parameter settings, thereby reducing physician effort and improving patient comfort (as suggested by Lee, “From the patient's view point, the systems will operate in the same manner and be controlled in the same manner, such that the patient's subjective experience in using the trial system more closely matches what would be experienced in using the permanently implanted system. Thus, this configuration reduces any uncertainties the patient may have as to how the system will operate and be controlled such that the patient will be more likely to convert a trial system to a permanent system .”, pg. 10, paragraph 0094, lines 17-25). Further, one skilled in the art could have combined the elements as described above by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results. Therefore, it would have been obvious to combine the teachings of Goetz with Lee to obtain the invention as specified in claim 1.
Regarding claim 2, Goetz in view of Lee teaches the system of claim 1, wherein the anatomical region comprises a target anatomical element, and wherein the target anatomical element comprises a vertebra and the anatomical element comprises a spinal cord (Goetz, “In addition, image analysis may be used to determine positioning of electrodes relative to anatomical targets, e.g., particular vertebrae of the spinal column in the case of SCS.”, column 15, lines 25-27, see Fig. 10).
Regarding claim 3, Goetz in view of Lee teaches the system of claim 2, wherein the memory stores further data for processing by the processor that, when processed, causes the processor to:
process the first image to identify the target anatomical element and the initial lead; and process the second image to identify the target anatomical element and the implanted lead (Goetz, “Using post-implant imagery, the implanted leads may be characterized to identify the type or types of leads implanted within a patient and/or determine positions of the implanted leads and/or electrodes carried by the leads relative to one another and/or or relative to anatomical structures within the patient.”, column 8, lines 52-57, “As an additional or alternative purpose, relative spacing between electrodes in the lead configuration may be used to detect lead migration over time. For example, lead characteristics such as relative spacing of electrodes may be obtained from different images taken at different times, and then compared to determine whether one or more of the electrodes has shifted relative to a previous position. Migration may be detected by comparing the positions to anatomical landmarks either by automated image processing, manual inspection, or both.”, columns 44 and 45, lines 51-67 and 1-3, respectively, “Anatomical features also can be registered to the same scale and coordinates as the electrodes, allowing a "distance to target," i.e., a distance between an electrode and an anatomical target, to be used by programmer 20 in making automatic adjustments to stimulation parameters such as amplitude. For example, image processing device 52 or programmer 20 may ask the user to pick key landmarks on the anatomy in the image, e.g., by tracing aspects of anatomy such as vertebra, by atlas overlay, or by other techniques.”, column 48, lines 53-62, Each image is analyzed independently to identify implanted leads and their position relative to anatomical structures, such as vertebrae of the spine, identified by users.).
Regarding claim 4, Goetz in view of Lee teaches the system of claim 2, wherein generating the lead parameter comprises:
Determining a first pose of the initial lead relative to the target anatomical element in the first image and a second pose of the implanted lead relative to the target anatomical element in the second image (Goetz, “As will be described, in some embodiments, multiple images may be obtained from different perspectives to ascertain relative positioning of electrodes in different dimensions.”, column 15, lines 22-27, “The lead characterization data may include a determination of the configuration of the one or more implanted leads, such as lead types, lead orientations, lead positions, number of leads, and relative positions of the electrodes carried by the leads, based on the analysis by image analysis unit 60 and lead characterization unit 62.”, column 21, lines 11-18, Each image is analyzed independently to identify implanted leads and their position, orientation, and spacing relative to each other or anatomical structures.);
Determining a difference between the first pose and the second pose; and applying the difference to the initial lead parameter to generate the implanted lead parameter (Goetz, “As an additional or alternative purpose, relative spacing between electrodes in the lead configuration may be used to detect lead migration over time. For example, lead characteristics such as relative spacing of electrodes may be obtained from different images taken at different times, and then compared to determine whether one or more of the electrodes has shifted relative to a previous position. Migration may be detected by comparing the positions to anatomical landmarks either by automated image processing, manual inspection, or both.”, columns 44 and 45, lines 51-67 and 1-3, respectively, The pose of the implanted lead is compared between initial implanted lead images and subsequent lead images. This lead migration determination allows the system to update initial lead parameters.).
Regarding claim 5, Goetz in view of Lee teaches the system of claim 2, wherein the memory stores further data for processing by the processor that, when processed, causes the processor to:
receive a third image of the anatomical region, the third image depicting the anatomical element and at least a portion of the implanted lead; and generate an updated implanted lead parameter for the implanted lead based on a combination of the implanted lead parameter and a correlation of the second image with the third image (Goetz, “As an additional or alternative purpose, relative spacing between electrodes in the lead configuration may be used to detect lead migration over time. For example, lead characteristics such as relative spacing of electrodes may be obtained from different images taken at different times, and then compared to determine whether one or more of the electrodes has shifted relative to a previous position. Migration may be detected by comparing the positions to anatomical landmarks either by automated image processing, manual inspection, or both.”, columns 44 and 45, lines 51-67 and 1-3, respectively, Lead parameter updates can be applied iteratively each time subsequent imaging is taken of the patient.).
Regarding claim 6, Goetz in view of Lee teaches the system of claim 5, wherein generating the updated implanted lead parameter comprises:
determining a first pose of the implanted lead relative to the target anatomical element in the second image and a second pose of the implanted lead relative to the target anatomical element in the third image (Goetz, “As will be described, in some embodiments, multiple images may be obtained from different perspectives to ascertain relative positioning of electrodes in different dimensions.”, column 15, lines 22-27, “The lead characterization data may include a determination of the configuration of the one or more implanted leads, such as lead types, lead orientations, lead positions, number of leads, and relative positions of the electrodes carried by the leads, based on the analysis by image analysis unit 60 and lead characterization unit 62.”, column 21, lines 11-18, Each subsequent image is analyzed independently to identify implanted leads and their position, orientation, and spacing relative to each other or anatomical structures);
determining a difference between the first pose and the second pose; and applying the difference to the implanted lead parameter to generate the updated implanted lead parameter (Goetz, “As an additional or alternative purpose, relative spacing between electrodes in the lead configuration may be used to detect lead migration over time. For example, lead characteristics such as relative spacing of electrodes may be obtained from different images taken at different times, and then compared to determine whether one or more of the electrodes has shifted relative to a previous position. Migration may be detected by comparing the positions to anatomical landmarks either by automated image processing, manual inspection, or both.”, columns 44 and 45, lines 51-67 and 1-3, respectively, The pose of the implanted lead is compared between subsequent lead images. This lead migration determination allows the system to continuously update lead parameters.).
Regarding claim 7, Goetz in view of Lee teaches the system of claim 1, wherein the first image comprises one or more representations of an X-ray image of the anatomical region and the initial lead (Goetz, see Fig. 10), and wherein the memory stores further data for processing by the processor that, when processed, causes the processor to:
segmenting the one or more representations to identify the anatomical element and the initial lead (Goetz, “FIG. 11B represents the result of binarization of the image of FIG. llA, e.g., using threshold filtering to convert the cropped gray scale image of FIG. 10 into a binary (black/white) image. When the image is converted to black and white, the key objects remaining in the image are the electrodes, as shown in FIG. 11B. After the black/white image of FIG. 11B is generated, image processing device 52 may detect "blobs." A blob is a connected group of 'object' pixels, i.e., pixels designated as a "1." As described above, pixels for electrodes are darker than other pixels and are designated with a value of "1." Therefore, a blob may generally correspond to an electrode of a lead.”, column 33, lines 53-64, “Anatomical features also can be registered to the same scale and coordinates as the electrodes, allowing a "distance to target," i.e., a distance between an electrode and an anatomical target, to be used by programmer 20 in making automatic adjustments to stimulation parameters such as amplitude. For example, image processing device 52 or programmer 20 may ask the user to pick key landmarks on the anatomy in the image, e.g., by tracing aspects of anatomy such as vertebra, by atlas overlay, or by other techniques.”, column 48, lines 53-62,).
Regarding claim 8, Goetz in view of Lee teaches the system of claim 1, wherein the first image comprises a plurality of representations of the X-ray image of the anatomical region and the initial lead, and wherein the memory stores further data for processing by the processor that, when processed, causes the processor to: combine the plurality of representations to form a single representation (Goetz, “Also, in some embodiments, an initial electronic image may include two or more images from different perspectives, e.g., to aid in generation of three-dimensional positioning information.”, column 7, lines 31-34).
Regarding claim 10, Goetz in view of Lee teaches the system of claim 1, wherein the anatomical region comprises at least one of a spinal region or a cranial region (Goetz, “In some embodiments, identified leads may be clustered into groups by system 10. For example, system 10 may have a first set of two leads with four electrodes each (2x4) implanted high in the spine…”, column 9, lines 1-4, see Fig. 10).
Regarding claim 11, Goetz in view of Lee teaches the system of claim 1, wherein the pulse generator is implantable (Goetz, “FIG. 1A is a schematic diagram illustrating an implantable stimulation system 10 including a pair of implantable electrode arrays in the form of stimulation leads 16A, 16B implanted within a patient 12. As shown in FIG. 1A, system 10 includes an implantable stimulator 14 and an external programmer 20 shown in conjunction with patient 12.”, column 8, lines 4-9, see Fig. 1A, implantable stimulator 14).
Claim 12 corresponds to claim 1, with the addition of process the first image to identify the anatomical element and the initial lead, process the second image to identify the anatomical element and the implanted lead, and generate an implanted lead parameter for the lead based on a combination of the initial lead parameter, a correlation of the anatomical element of the first image with the anatomical element of the second image, and a correlation of the initial lead of the first image with the implanted lead of the second image.
Goetz in view of Lee teaches the addition of process the first image to identify the anatomical element and the initial lead, process the second image to identify the anatomical element and the implanted lead (Goetz, “Using post-implant imagery, the implanted leads may be characterized to identify the type or types of leads implanted within a patient and/or determine positions of the implanted leads and/or electrodes carried by the leads relative to one another and/or or relative to anatomical structures within the patient.”, column 8, lines 52-57, “As an additional or alternative purpose, relative spacing between electrodes in the lead configuration may be used to detect lead migration over time. For example, lead characteristics such as relative spacing of electrodes may be obtained from different images taken at different times, and then compared to determine whether one or more of the electrodes has shifted relative to a previous position. Migration may be detected by comparing the positions to anatomical landmarks either by automated image processing, manual inspection, or both.”, columns 44 and 45, lines 51-67 and 1-3, respectively, “Anatomical features also can be registered to the same scale and coordinates as the electrodes, allowing a "distance to target," i.e., a distance between an electrode and an anatomical target, to be used by programmer 20 in making automatic adjustments to stimulation parameters such as amplitude. For example, image processing device 52 or programmer 20 may ask the user to pick key landmarks on the anatomy in the image, e.g., by tracing aspects of anatomy such as vertebra, by atlas overlay, or by other techniques.”, column 48, lines 53-62, Each image is analyzed independently to identify implanted leads and their position relative to anatomical structures, such as vertebrae of the spine, identified by users.), and generate an implanted lead parameter for the implanted lead based on a combination of the initial lead parameter, a correlation of the anatomical element of the first image with the anatomical element of the second image, and a correlation of the initial lead of the first image with the implanted lead of the second image; and control the pulse generator to stimulate the anatomical element based on the implanted lead parameter (Goetz, “With the aid of anatomical positioning information, programmer 20 may automatically generate further adjustments to one or more parameters, either for automatic application or application upon review and approval by the user. If the anatomical positioning information indicates that the distance of one or more electrodes in an electrode combination to an anatomical target is longer or shorter than a default distance of distance range, then programmer 20 may automatically adjust an amplitude or other parameter upward or downward, respectively.”, column 28, lines 21-30, “As an additional or alternative purpose, relative spacing between electrodes in the lead configuration may be used to detect lead migration over time. For example, lead characteristics such as relative spacing of electrodes may be obtained from different images taken at different times, and then compared to determine whether one or more of the electrodes has shifted relative to a previous position… Using migration information, such as relative spacing differences, programmer 20, may automatically adjust or propose adjustments to one or more stimulation parameters, e.g., in a manner similar to that described above.”, columns 44 and 45, lines 51-67 and 1-3, respectively, Updated lead parameters are generated by comparing lead positions across initial and subsequent images of the patient. This includes computing distance values, such as distances between leads or leads and anatomical structures to determine the updated parameters accounting for lead migration. To perform these calculations, the system correlates the positions of the same anatomical structures and the same leads across the images.).
As indicated in the analysis of claim 1, Goetz in view of Lee teaches all the limitations according to claim 1. Therefore, claim 12 is rejected for the same reasons as claim 1.
Regarding claim 13, Goetz in view of Lee teaches the system of claim 12, wherein the first image comprises at least one of an optical image, a fluoroscopic image, an x-ray image, or a three-dimensional image (Goetz, “In operation, following implantation of one or more leads within a patient to form a lead configuration, a caregiver may obtain a post-implantation image of the lead configuration within the patient using any of a various imaging modalities, such as fluoroscopy, x-ray imaging, magnetic resonance imaging (MRI) or ultrasound imaging.”, column 7, lines 17-22).
Regarding claim 14, Goetz in view of Lee teaches the system of claim 12, wherein the second image comprises at least one of an optical image, an x-ray image, or a three-dimensional image (Goetz, “In operation, following implantation of one or more leads within a patient to form a lead configuration, a caregiver may obtain a post-implantation image of the lead configuration within the patient using any of a various imaging modalities, such as fluoroscopy, x-ray imaging, magnetic resonance imaging (MRI) or ultrasound imaging.”, column 7, lines 17-22).
Regarding claim 20, Goetz teaches A system for generating a lead parameter, comprising:
a processor; and a memory (Goetz, “In a further embodiment, the disclosure provides a computer-readable medium comprising instructions to cause a processor to analyze an electronic image of an electrical stimulation electrode array implanted within a patient to identify one or more physical characteristics of the electrode array”, column 2, lines 52-57, see Fig. 2, processor 24) storing data for processing by the processor, the data, when processed, causes the processor to:
receive an optical image of an anatomical region comprising an anatomical element and an initial lead positioned near the anatomical element (Goetz, “In operation, following implantation of one or more leads within a patient to form a lead configuration, a caregiver may obtain a post-implantation image of the lead configuration within the patient using any of a various imaging modalities…”, column 7, lines 17-20, “Using post-implant imagery, the implanted leads may be characterized to identify the type or types of leads implanted within a patient and/or determine positions of the implanted leads and/or electrodes carried by the leads relative to one another and/or or relative to anatomical structures within the patient.”, column 8, lines 52-57, see Fig. 10);
process the optical image to identify the anatomical element and the initial lead in the optical image (Goetz, “Using post-implant imagery, the implanted leads may be characterized to identify the type or types of leads implanted within a patient and/or determine positions of the implanted leads and/or electrodes carried by the leads relative to one another and/or or relative to anatomical structures within the patient.”, column 8, lines 52-57, “As an additional or alternative purpose, relative spacing between electrodes in the lead configuration may be used to detect lead migration over time. For example, lead characteristics such as relative spacing of electrodes may be obtained from different images taken at different times, and then compared to determine whether one or more of the electrodes has shifted relative to a previous position. Migration may be detected by comparing the positions to anatomical landmarks either by automated image processing, manual inspection, or both.”, columns 44 and 45, lines 51-67 and 1-3, respectively, “Anatomical features also can be registered to the same scale and coordinates as the electrodes, allowing a "distance to target," i.e., a distance between an electrode and an anatomical target, to be used by programmer 20 in making automatic adjustments to stimulation parameters such as amplitude. For example, image processing device 52 or programmer 20 may ask the user to pick key landmarks on the anatomy in the image, e.g., by tracing aspects of anatomy such as vertebra, by atlas overlay, or by other techniques.”, column 48, lines 53-62, Each image is analyzed independently to identify implanted leads and their position relative to anatomical structures, such as vertebrae of the spine, identified by users.);
receive an initial lead parameter (Goetz, “An image processing device analyzes the image to identify one or more physical characteristics of the lead or leads in the lead configuration… A user may rely on the characterization information to manually adjust various electrical stimulation parameters. Alternatively, or additionally, an automatic or guided programming algorithm may rely on the information to automatically adjust various electrical stimulation parameters. Adjustment of stimulation parameters may refer to initial setting of parameters or modification of existing parameters.”, column 7, lines 35-51, Patient images are obtained for implanted lead identification. This includes determining characterization information for the leads, and using this to adjust or set Initial lead parameters.);
receive an additional image of the anatomical region depicting the implanted lead positioned near the anatomical element; process the additional image to identify the anatomical element and the implanted lead in the additional image; correlate the identified anatomical element and the initial lead from the optical image and the identified anatomical element and the implanted lead from the additional image; generate an implanted lead parameter based on the correlation and the initial lead parameter; and control the pulse generator to stimulate the anatomical element based on the implanted lead parameter (Goetz, “In addition to specifying lead configuration and parameters, programmer 20 may be configured to accept updated lead characterization data at a later time in order to accommodate possible lead migration. For example, at some time after initial implantation, e.g., days, months or years, a patient may return to the clinic to permit imaging modality 50 to obtain one or more subsequent electronic images of the implanted lead configuration. Image processing device 52 then may analyze the subsequent electronic image or images (100), and automatically generate an updated lead characterization (102) based on the analysis of the subsequent electronic image.”, column 28, lines 43-54, “As an additional or alternative purpose, relative spacing between electrodes in the lead configuration may be used to detect lead migration over time. For example, lead characteristics such as relative spacing of electrodes may be obtained from different images taken at different times, and then compared to determine whether one or more of the electrodes has shifted relative to a previous position… Using migration information, such as relative spacing differences, programmer 20, may automatically adjust or propose adjustments to one or more stimulation parameters, e.g., in a manner similar to that described above.”, columns 44 and 45, lines 51-67 and 1-3, respectively, The initial lead parameters can be adjusted based on subsequent imaging. Lead migration is determined by comparing patient images from different times, and this information is used to update parameter settings for lead stimulation.).
Goetz does not teach wherein the initial lead is temporarily implanted into the anatomical region for a duration of a test period during which the anatomical element is stimulated via the initial lead; an initial lead parameter generated based on the stimulation of the anatomical element via the initial lead during the test period; and receive, after the test period and after the initial lead is replaced by the implanted lead in the anatomical region, an additional image of the anatomical region.
However, Lee teaches wherein the initial lead is temporarily implanted into the anatomical region for a duration of a test period during which the anatomical element is stimulated via the initial lead; an initial lead parameter generated based on the stimulation of the anatomical element via the initial lead during the test period; and receive, after the test period and after the initial lead is replaced by the implanted lead in the anatomical region, an additional image of the anatomical region (Lee, similar to the analysis of claim 1, see pg. 3, paragraph 0044, lines 1-5, pg. 4, paragraph 0050, lines 1-13, and pg. 10, paragraph 0094, lines 1-17, see Fig. 15).
Goetz teaches updating lead stimulation parameters by analyzing post-implant images to account for lead migration over time (Goetz, column 28, lines 43-54 and columns 44 and 45, lines 51-67 and 1-3, respectively). Goetz does not teach implementing a test period where a temporary lead is implanted. Lee teaches a trial neurostimulation system for an evaluation period, which uses a temporary implanted lead that is later replaced by a permanently implanted lead (see above). Lee further teaches using the same clinician programmer for lead placement, programming, and stimulation control to transition from trail to permanent implantations (Lee, paragraph 0094). Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified the lead parameter updating of Goetz to be applied to the transition from temporary to permanent implantation as taught by Lee (see paragraph 0050 and 0094). The motivation for doing so would have been to account for lead migration across implantations to maintain consistent parameter settings, thereby reducing physician effort and improving patient comfort (as suggested by Lee, “From the patient's view point, the systems will operate in the same manner and be controlled in the same manner, such that the patient's subjective experience in using the trial system more closely matches what would be experienced in using the permanently implanted system. Thus, this configuration reduces any uncertainties the patient may have as to how the system will operate and be controlled such that the patient will be more likely to convert a trial system to a permanent system .”, pg. 10, paragraph 0094, lines 17-25). Further, one skilled in the art could have combined the elements as described above by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results. Therefore, it would have been obvious to combine the teachings of Goetz with Lee to obtain the invention as specified in claim 20.
Regarding claim 16, Goetz in view of Lee teaches the system of claim 12, wherein the anatomical region comprises a target anatomical element, and the memory stores further data for processing by the processor that, when processed, causes the processor to:
process the first image to identify the target anatomical element and the initial lead; and process the second image to identify the target anatomical element and the implanted lead (Goetz, “Using post-implant imagery, the implanted leads may be characterized to identify the type or types of leads implanted within a patient and/or determine positions of the implanted leads and/or electrodes carried by the leads relative to one another and/or or relative to anatomical structures within the patient.”, column 8, lines 52-57, “As an additional or alternative purpose, relative spacing between electrodes in the lead configuration may be used to detect lead migration over time. For example, lead characteristics such as relative spacing of electrodes may be obtained from different images taken at different times, and then compared to determine whether one or more of the electrodes has shifted relative to a previous position. Migration may be detected by comparing the positions to anatomical landmarks either by automated image processing, manual inspection, or both.”, columns 44 and 45, lines 51-67 and 1-3, respectively, “Anatomical features also can be registered to the same scale and coordinates as the electrodes, allowing a "distance to target," i.e., a distance between an electrode and an anatomical target, to be used by programmer 20 in making automatic adjustments to stimulation parameters such as amplitude. For example, image processing device 52 or programmer 20 may ask the user to pick key landmarks on the anatomy in the image, e.g., by tracing aspects of anatomy such as vertebra, by atlas overlay, or by other techniques.”, column 48, lines 53-62, Each image is analyzed independently to identify implanted leads and their position relative to anatomical structures, such as vertebrae of the spine, identified by users.).
Regarding claim 17, Goetz in view of Lee teaches the system of claim 16, wherein generating the implanted lead parameter comprises:
determining a first pose of the initial lead relative to the target anatomical element in the first image and a second pose of the implanted lead relative to the target anatomical element in the second image (Goetz, “As will be described, in some embodiments, multiple images may be obtained from different perspectives to ascertain relative positioning of electrodes in different dimensions.”, column 15, lines 22-27, “The lead characterization data may include a determination of the configuration of the one or more implanted leads, such as lead types, lead orientations, lead positions, number of leads, and relative positions of the electrodes carried by the leads, based on the analysis by image analysis unit 60 and lead characterization unit 62.”, column 21, lines 11-18, Each image is analyzed independently to identify implanted leads and their position, orientation, and spacing relative to each other or anatomical structures.);
determining a difference between the first pose and the second pose; and applying the difference to the initial lead parameter to generate the implanted lead parameter (Goetz, “As an additional or alternative purpose, relative spacing between electrodes in the lead configuration may be used to detect lead migration over time. For example, lead characteristics such as relative spacing of electrodes may be obtained from different images taken at different times, and then compared to determine whether one or more of the electrodes has shifted relative to a previous position. Migration may be detected by comparing the positions to anatomical landmarks either by automated image processing, manual inspection, or both.”, columns 44 and 45, lines 51-67 and 1-3, respectively, The pose of the implanted lead is compared between initial implanted lead images and subsequent lead images. This lead migration determination allows the system to update initial lead parameters.).
Regarding claim 18, Goetz in view of Lee teaches the system of claim 16, wherein the memory stores further data for processing by the processor that, when processed, causes the processor to: receive a third image of the anatomical region, the third image depicting the anatomical element and at least a portion of the implanted lead; and generate an updated implanted lead parameter for the implanted lead based on a combination of the implanted lead parameter and a correlation of the second image with the third image (Goetz, “As an additional or alternative purpose, relative spacing between electrodes in the lead configuration may be used to detect lead migration over time. For example, lead characteristics such as relative spacing of electrodes may be obtained from different images taken at different times, and then compared to determine whether one or more of the electrodes has shifted relative to a previous position. Migration may be detected by comparing the positions to anatomical landmarks either by automated image processing, manual inspection, or both.”, columns 44 and 45, lines 51-67 and 1-3, respectively, Lead parameter updates can be applied iteratively each time subsequent imaging is taken of the patient.).
Regarding claim 19, Goetz in view of Lee teaches the system of claim 18, wherein generating the updated implanted lead parameter comprises:
determining a first pose of the implanted lead relative to the target anatomical element in the second image and a second pose of the implanted lead relative to the target anatomical element in the third image (Goetz, “As will be described, in some embodiments, multiple images may be obtained from different perspectives to ascertain relative positioning of electrodes in different dimensions.”, column 15, lines 22-27, “The lead characterization data may include a determination of the configuration of the one or more implanted leads, such as lead types, lead orientations, lead positions, number of leads, and relative positions of the electrodes carried by the leads, based on the analysis by image analysis unit 60 and lead characterization unit 62.”, column 21, lines 11-18, Each image is analyzed independently to identify implanted leads and their position, orientation, and spacing relative to each other or anatomical structures.);
determining a difference between the first pose and the second pose; and applying the difference to the implanted lead parameter to generate the updated lead parameter (Goetz, “As an additional or alternative purpose, relative spacing between electrodes in the lead configuration may be used to detect lead migration over time. For example, lead characteristics such as relative spacing of electrodes may be obtained from different images taken at different times, and then compared to determine whether one or more of the electrodes has shifted relative to a previous position. Migration may be detected by comparing the positions to anatomical landmarks either by automated image processing, manual inspection, or both.”, columns 44 and 45, lines 51-67 and 1-3, respectively, The pose of the implanted lead is compared between initial implanted lead images and subsequent lead images. This lead migration determination allows the system to update initial lead parameters.).
Claims 9 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Goetz et al. (US 9259589 B2) in view of Lee et al. (US 20220080212 A1) and further in view of Pathak et al. (US 20220202491 A1), (hereinafter Pathak).
Regarding claim 9, Goetz in view of Lee teaches the system of claim 1. Goetz in view of Lee does not teach wherein the memory stores further data for processing by the processor that, when processed, causes the processor to: generate a trajectory for placing the implanted lead near the anatomical element.
However, Pathak teaches wherein the memory stores further data for processing by the processor that, when processed, causes the processor to: generate a trajectory for placing the implanted lead near the anatomical element (Pathak, “In one implementation, a representation of a selected electrode (e.g., a graphic symbol, pictorial image, pictogram, or an icon, etc. associated therewith) may be automatically generated at a path that hits or terminates at a specific location
of a selected ROI (e.g., the center of the target region) while avoiding the ROAs such as, e.g., blood vessels, ventricles, etc. Given the respective locations of the ROIs and ROAs identified in reference to a known coordinate system, any known or heretofore unknown path optimization process may be executed to calculate, obtain, estimate or otherwise determine an optimal trajectory, as set forth at block 234.”, pgs. 5 and 6, paragraph 0042, lines 11-22, “As noted previously, any suitable imaging technology can be utilized such as MRI systems, CT systems, etc., for obtaining pre-operative and/or
intra-operative imaging data of the patient's brain… Based upon the imaging information, the trained ML-based trajectory planning scheme may be executed to provide real time target location information and optimal path data to a stereotactic surgery system including the guiding apparatus as described.”, pgs. 9 and 10, paragraph 0068, lines 21-34, see Fig. 2E-2G).
Goetz in view of Lee teaches analyzing post-implant images to adjust lead parameters of a neurostimulation systems (Goetz,” Using lead characterization data, external programmer 20 may present suitable programming options and parameters, consistent with the lead configuration indicated by the lead characterization data.”, column 25, lines 39-42, see Fig. 8). Pathak teaches analyzing images prior to lead implantation to generate trajectory paths for lead placement (see above). Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Goetz in view of Lee to include trajectory planning for lead placement as taught by Pathak (Pathak, pgs. 5 and 6, paragraph 0042, lines 11-22 , pgs. 9 and 10, paragraph 0068, lines 21-34, see Fig. 2E-2G). The motivation for doing so would have been to provide guidance for precise lead placement, thereby improving the accuracy and effectiveness of targeted stimulation (as suggested by Pathak, “Brain anatomy typically requires precise targeting of tissue for stimulation by deep brain stimulation systems. For example, deep brain stimulation for Parkinson's disease commonly targets tissue within or close to the subthalamic nucleus (STN). The STN is a relatively small structure with diverse functions. Stimulation of undesired portions of the STN or immediately surrounding tissue can result in negative side effects”, pg. 1, paragraph 0003). Further, one skilled in the art could have combined the elements as described above by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results. Therefore, it would have been obvious to combine the teachings of Goetz in view of Lee with Pathak to obtain the invention as specified in claim 9.
Regarding claim 15, Goetz in view of Lee teaches the system of claim 12. Goetz in view of Lee does not teach wherein the memory stores further data for processing by the processor that, when processed, causes the processor to: generate a trajectory for placing the implanted lead near the anatomical element.
However, as indicated in the analysis of claim 9, the combination of Goetz in view of Lee and Pathak teaches wherein the memory stores further data for processing by the processor that, when processed, causes the processor to: generate a trajectory for placing the implanted lead near the anatomical element (see analysis of claim 9 above). Therefore, claim 15 is rejected for the same reasons of obviousness as claim 9.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/CONNOR L HANSEN/Examiner, Art Unit 2672
/SUMATI LEFKOWITZ/Supervisory Patent Examiner, Art Unit 2672
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