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
Regarding claim objections
Examiner notes that the previously set forth claim objections are withdrawn in view of the amendments to the claims.
Regarding claim interpretation
Examiner notes that the previously set forth claim interpretations regarding intended use are withdrawn in view of the amendments to the claims.
Regarding 35 U.S.C. 101
Applicant's arguments filed 05/18/2026 have been fully considered but they are not persuasive.
For example, applicant argues “it is unreasonably broad to conclude that the human mind is equipped to determine amount of adhesion between an implantable device and tissue by analysis of X-ray attenuation” (REMARKS pg. 11). Examiner respectfully disagrees in that first it is noted that analysis of X-ray attenuation is not a requirement of the claim, but rather the claim broadly recites determining an amount of adhesion between an implantable device and tissue based on the attenuation data. Therefore the claim broadly recites determining an amount of adhesion between an implantable device and tissue without reciting any specificity as to how such determining is done nor how it is based on the attenuation data, where based on the attenuation data could merely be using the attenuation data (or a derivative thereof) to determine a location of the tissue, the implantable device, or use it for merely reference. Furthermore, it is noted that even if the claim required analysis of the attenuation data that such a limitation is broad and would read on merely analyzing CT image data to determine an amount of adhesion and applicant’s originally filed specification discloses that determining the amount of adhesion may be performed using a functional relationship between HU values and adhesion classes or scores such that voxels contacting the implantable device that have relatively lower HU values are mapped to adhesion classes or adhesion scores, representing a relatively low amount of adhesion, whereas voxels contacting the implantable device that have relatively higher HU values, are mapped to adhesion classes, or scores, representing a relatively higher amount of adhesion where such a functional relationship could reasonably be applied by a human analyzing a CT image and voxels therein to identify relatively higher/lower HU values of pixels and corresponding higher/lower amount(s) of adhesion accordingly. Applicant’s arguments that it is unreasonable broad to conclude that the human mind is equipped to determine an amount of adhesion between an implantable device and tissue by analysis of X-ray attenuation is considered merely conclusory without any evidence as to the complexities associated with such a determination that would render the limitation unable to be performed in the mind by a human. Arguments presented by applicant cannot take the place of evidence in the record (MPEP 2145). For at least the reasons listed above, applicant’s arguments are not found persuasive.
Applicant further argues “If the Office continues to interpret the claim as directed to an abstract idea, as the above element (“determine an amount of adhesion between the implantable device and a tissue contacting the implantable device based on the attenuation data [defining X-ray attenuation within the anatomical region]”) is not a mental process, this element should be analyzed as an ‘additional limitation’ of the claim. Clearly this additional limitation provides the practical application of the determination of the amount of adhesion between the implantable device and a tissue contacting the implantable device for guiding an implantable device extraction procedure” (REMARKS pg. 11). Examiner respectfully disagrees in that as noted above, determining an amount of adhesion between the implantable device and a tissue contacting the implantable device based on the attenuation data is considered to be directed to a judicial exception (i.e. abstract idea/mental process) and not an additional element. Therefore applicant’s arguments that the above element is an additional element which provides the practical application is not found persuasive.
Applicant further argues “the claimed invention improves this field by providing a new reliable, non-invasive technique for guiding the extraction of an implantable device that determines an amount of adhesion between the implantable device and a tissue contacting the implantable device from X-ray attenuation within the anatomical region. Further, pages 10-14 of the specification provides specific, detailed example embodiments of the determination of an amount of adhesion between the implantable device and a tissue contacting the implantable device form X-ray attenuation with in the anatomical region” (REMARKS pg. 11-12). Examiner respectfully disagrees in that as noted above, the limitation regarding determining an amount of adhesion is considered a judicial exception and it is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements (See MPEP 2106.05(a)). Therefore applicants arguments that the claimed invention improves the field through determining an amount of adhesion between the implantable device and a tissue contacting the implantable device from X-ray attenuation within the anatomical region are not found persuasive as the alleged improvement cites to merely the judicial exception.
Applicant finally argues “the additional limitations of claim 1 indeed contributes an inventive concept that improves the field of implantable device extraction procedures. As described above, the additional limitations determines an amount of adhesion between the implantable device and a tissue contacting the implantable device from X-ray attenuation within the anatomical region for guidance of an implantable device extraction procedure. Such manner of determining the amount of adhesion between the implantable device and a tissue contacting the implantable device is not well-understood, routine, conventional activity in this technical field” (REMARKS pg. 12). Examiner respectfully disagrees in that as noted above, determining an amount of adhesion between the implantable device and a tissue contacting the implantable device based on the attenuation data is considered to be directed to a judicial exception (i.e. abstract idea/mental process) and therefore is not an additional element which may be considered for amounting to significantly more. Therefore applicant’s arguments that the above element is an additional element which provides the practical application is not found persuasive.
Regarding prior art
Applicant's arguments filed 05/18/2026 have been fully considered but they are not persuasive.
For example, applicant argues “the cited passages of Grass do not disclose to determine an amount of adhesion based on attenuation data the defines X-ray attenuation within an anatomical region. Rather the cited paragraphs of Grass disclose to determine the degree of local adhesion to the vessel wall by quantifying a local motion of the lead relative to the vessel wall from a temporal sequence of three-dimensional image data received via the input and determining a degree of local adhesion based on the local motion. To one skilled in the art, it would be unreasonably broad to interpret the claimed attenuation data defining x-ray attenuation within the anatomical region’ as Grass’s ‘local motion of the lead’. Such interpretation appears to disregard the meaning in the art of X-ray attenuation” (REMARKS pg. 13). Examiner respectfully disagrees in that the attenuation data is not necessarily equated to the local motion of the lead as applicant appears to understand the cited passages. Applicant explicitly notes that the local motion of the lead relative to the vessel wall is quantified from a temporal sequence of three-dimensional image data received. Examiner notes that pg. 11 lines 7-21 that the local motion of the lead is quantified from a 4D CT dataset comprising a plurality of 3D images and pg. 10 lines 27-33 the three dimensional image data is disclosed as one or more coregistered 3D reconstructions, such as non-contrast enhanced CT image volume and a contrast enhanced CT image volume, or multiple spectral CT image volumes. Where examiner notes that CT image volumes are considered to be/include attenuation data defining x-ray attenuation within the anatomical region. Therefore, it is noted that by determining a degree of local adhesion by quantifying the local motion of the lead from a temporal sequence of three-dimensional image data (i.e. attenuation data defining X-ray attenuation within the anatomical region) that determining the amount of adhesion is necessarily based on the attenuation data (i.e. the temporal sequence of three-dimensional image data). Applicant’s focus on the mere disclosure regarding the degree of local adhesion being based on the local motion of the lead appears to omit any recognition that the local motion of the lead is quantified from the three-dimensional images and thus from the attenuation data. For at least the reasons listed above, applicant’s arguments with respect to the teachings of Grass are not found persuasive.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception in the form of an abstract idea without significantly more.
In a test for patent subject matter eligibility, the claims pass Step 1 (see 2019 Revised Patent Subject Matter Eligibility), as they are related to a process, machine, manufacture, or composition of matter.
When assessed under Step2A, Prong I, Independent claims 1 and 17 are found to recite a judicial exception (i.e. abstract idea). In this instance, claims 1 and 16-17 recite the limitations “determine an amount of adhesion between the implantable device and a tissue contacting the implantable device” and “determine… output guidance information comprising one or more indications configured to guide the implantable device extraction procedure based on the amount of adhesion”. The cited limitation(s), under their broadest reasonable interpretation, encompass a mental process (i.e. abstract idea) of analyzing data which can be performed in the mind or by a human using a pen and a paper (e.g. observation, evaluation, judgment, opinion). In other words, a person could reasonably determine an amount of adhesion between the implantable device and a tissue contacting the implantable device based on the attenuation device via observation/evaluation of the x-ray attenuation data (i.e. looking at an CT image) or by some other means where the position of the lead or other data from the x-ray attenuation data is merely used as a reference (i.e. based on the attenuation data). More specifically, it is noted that applicant’s specification explicitly recites a functional relationship between HU values and adhesion classes where voxels contacting the implantable device that have a relatively lower HU values are mapped to adhesion classes representing a relatively low amount of adhesion where voxels contact the implantable device that have a relatively higher HU values are mapped to adhesion classes representing a relatively higher amount of adhesion. Such disclosure provides support that a person having ordinary skill in the art could look at pixels in a CT image (where pixel values are representative of HU values) contacting the implantable device and reasonably determine an amount of adhesion based thereon (i.e. by association low HU values with low adhesion and high HU values with high adhesion). Furthermore, a person could reasonably determine guidance information via observation/evaluation of the amount of adhesion. Examiner notes that with the exception of generic computer-implemented steps (e.g. one or more processors recited in claim 1 and non-transitory computer-readable storage medium in claim 16), there is nothing in the claims that preclude the limitation from being performed by a human, mentally or with pen and paper, thus the cited limitation(s) recites a judicial exception (MPEP 2106.04(a)) and the claim must be reviewed under Step 2A, Prong II to determine patent eligibility.
Step 2A, Prong II determines whether any claim recites an additional element that integrates the judicial exception into a practical application. Independent claims recites the following additional element(s):
Receive/receiving attenuation data representing an implantable device in an anatomical region, the attenuation data defining X-ray attenuation within the anatomical region
Output/outputting guidance information comprising one or more indications configured to guide the implantable device extraction procedure based on the amount of adhesion.
The additional element(s) in the cited independent claim(s) are not found to integrate the judicial exception into a practical application. In this case, receiving attenuation data amounts to merely insignificant pre-solution activity in the field of X-ray attenuation and outputting guidance information amounts to merely insignificant post-solution activity of outputting results/data. These elements are seen as adding insignificant extra-solution activity to the judicial exception. They do no more than link the judicial exception to a particular technological environment or field of use. Therefore, under step 2A Prong II the Judicial exception is not integrated into a practical application by additional elements of independent claims 1 and 16-17 and the claims must be reviewed under Step 2B to determine patent eligibility.
Step 2B determines where a claim amounts to significantly more.
The additional element(s) listed above do not amount to significantly more than the judicial exception. In this instance, as noted above, the additional elements amount to merely insignificant extra-solution activity of data gathering and outputting results. Additionally there is no improvement in the functioning of the computer or technological field, and there is no transformation of subject matter into a different state. Therefore, under Step 2B in a test for patent subject matter eligibility, the judicial exception of the independent claim(s) do not amount to significantly more and the independent claim(s) remain patent ineligible.
Dependent claims 2-15, and 18-20 further limit the abstract idea of independent claims 1 and 16. When analyzed as a whole, these claims are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitations fail to establish that the claims are not directed towards an abstract idea and do not sufficiently integrate the subject matter into a practical application or recite elements which constitute significantly more than the abstract ideas identified. The dependent claims are directed toward additional elements which encompass abstract ideas
In this instance, dependent claims recite the following limitations:
Determine a Hounsfield unit attenuation value of the tissue contacting the implantable device (claims 2 and 18)
Determine the amount of adhesion between the implantable device and the tissue contacting the implantable device based on the Hounsfield Unit attenuation value (claims 2 and 18)
Determine an amount of adhesion between the implantable device and a tissue contacting the implantable device, is performed for a plurality of positions along a length of the implantable device (claim 5)
Determine a total amount of adhesion between the implantable device and a tissue contacting the implantable device, based on the amount of adhesion between the implantable device and the tissue contacting the implantable device at the plurality of positions along the implantable device (claim 6)
determine a value of a risk metric, the value of the risk metric representing a risk of damage to a tissue represented in the attenuation data and/or a risk of fracturing the implantable device (claim 7)
Predicting the amount of adhesion between the implantable device and a tissue contacting the implantable device (claim 8)
Quantify the amount of adhesion between the implantable device and a tissue contacting the implantable device with one or more adhesion classes, or adhesion scores (claim 10)
determine a presence of implantable device-induced inflammation in the anatomical region (claim 11)
determine a stability metric for the implantable device (claim 12)
Calculate a recommended length of the implantable device to be extracted in the implantable device extraction procedure, the recommended length being calculated based on at least one of the amount of adhesion between the implantable device and a tissue contacting the implantable device, the stability metric, or the presence of the implantable device induced inflammation (claim 13)
Segment the received attenuation data to identify at least the implantable device, prior to analyzing the attenuation data (claim 14)
The cited limitation(s), under their broadest reasonable interpretation, encompass mental processes (i.e. abstract idea) which can be performed in the mind or by a human using a pen and a paper (e.g. observation, evaluation, judgment, opinion). In other words, a human could reasonably determine a Hounsfield unit attenuation value via observation/evaluation of attenuation data/pixel or voxel values, determine the amount of adhesion via observation/evaluation, determine the amount of adhesion for a plurality of positions and a total amount of adhesion via observation/evaluation, quantify the amount of adhesion, determine a value of a risk metric, predict the amount of adhesion, determine a stability metric, calculate a recommended length and segment the received attenuation data via observation/evaluation. Examiner notes that with the exception of generic computer-implemented steps (e.g. the one or more processors and the neural network of claim 8), there is nothing in the claims that preclude the limitation from being performed by a human, mentally or with pen and paper, thus the claimed limitation is considered to be directed towards a judicial exception (MPEP 2106.04(a)).
Under Step 2A, Prong II for dependent claims 2-15 and 18-20 present additional elements which only further narrow the judicial exceptions (e.g. claims 3 and 19 which further narrow the nature of the attenuation data merely directed to the technological field of multiple energy x-ray/computed tomography, claims 4 and 20 which further introduce applying a material decomposition algorithm which is found to be insignificant extra-solution activity of data processing in the field of multiple energy x-ray/computed tomography, claims 6-7 and 9 which further narrow the nature of the outputting, claim 8 which further recites inputting the received attenuation data into a neural network amounting to merely inputting data and further narrowing the nature in which the neural network is trained which amounts to merely a generic training a neural network, claims 11-13 which further introduce outputting indications amounting to merely insignificant post-solution activity of outputting data/results and claim 15 which further narrows the nature of the implantable device) and provide no additional element which are found to integrate the judicial exception into a practical application.
These dependent claims include no additional claims that are sufficient to amount to significantly more than the judicial exception. Additionally, there is no improvement in the functioning of the computer or technological field, and there is no transformation of subject matter into a different state. As discussed above with respect to integration of the abstract idea into a practical application, the additional claims do not provide any additional elements that would amount to significantly more than the judicial exception. Under Step 2B, these claims are not patent eligible.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 5-7, 9-12, and 14-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WIPO Grass et al. (WO 2020064518 A1), hereinafter Grass.
Regarding claims 1, 16, and 17,
Grass discloses a system for providing guidance information for an implantable device extraction procedure, the system comprising:
One or more processors (at least fig. 1 (2, 3, and 5) and corresponding disclosure in at least pg. 10 lines 14-19 and pg. 11 lines 22-29) configured to:
Receive attenuation data representing an implantable device in an anatomical region, the attenuation data defining X-ray attenuation within the anatomical region (pg. 11 lines 7-12 which discloses The input 2 may be 10 adapted for receiving a plurality of image volumes, representative of different acquisition times in a temporal sequence, e.g. the input may be adapted for receiving a four-dimensional (4D, i.e. three spatial dimensions and a temporal dimension) CT (or MRI) dataset.pg. 10 lines 20-31 which discloses the input unit 2 may be adapted for receiving a cardiac CT dataset of the thorax and the heart of the subject, e.g. including the entire lead, e.g. including a volume from a pacemaker pocket to the electrode ends and pg. 2 lines 24-35 which discloses receiving a live stream of x-ray projection image data. Examiner notes that both CT data and x-ray projection image data are attenuation data defining x-ray attenuation)
Analyze X-ray data to determine an amount of adhesion between the implantable device and a tissue contacting the implantable device (in pg. 4 lines 23-27 which discloses the preprocessor may be adapted for determining the degree of local adhesion to the vessel wall by quantifying a local motion of the lead relative to the vessel wall from a temporal sequence of three-dimensional image data received via the input and determining a degree of local adhesion based on the local motion and pg. 11 lines 4-21 which discloses the pre-processor may be adapted for determining parameters of interest from the segmented lead. For example a degree of local adhesion of the lead tip, and/or of the lead as a function of the longitudinal position along the lead, may be determined. The input 2 may be adapted for receiving a plurality of image volumes, representative of different acquisition times in a temporal sequence, e.g. the input may be adapted to receiving a four-dimensional (4D, i.e. three spatial dimensions and a temporal dimension) CT dataset. The processor 5 may be adapted for determining the local adhesion of the lead to the wall fo the body structure that contains the lead. For example, the 4D dataset may comprise a plurality of 3D images corresponding a plurality of points in time extending over at least one cardiac cycle and/or at least one breathing cycle, such that the local motion of the lead relative to the vessel wall, induced by the natural motion of the body, can be quantified, in which regions of the lead which shows a large motion relative to the wall e.g. a large variability of its position relative to the wall are indicative of a low or no adhesion, and in which regions of the lead which show a small motion relative to the wall are indicative of a high adhesion. Thus the adhesion can be quantified or determined in a straight-forward manner. see also pg. 17 lines 21-32 disclosing registering the fitted three-dimensional parametric model to the live stream of x-ray projection image data to correlate the position of the extraction device in the live stream); and
Determine and output guidance information comprising one or more indications configured to guide the implantable device extraction procedure based on the amount of adhesion (pg. 4 lines 16-22 which discloses the output may be adapted for outputting the parameter corresponding to a longitudinal position or ahead of the determined position of the extraction device. This parameter may comprise a local curvature and/or a degree of local adhesion of the lead and or a proximity of the lead to the vessel wall. Examiner notes that the output parameter comprises one or more indications (i.e. local curvature and/or a degree of local adhesion of the lead and/or a proximity of the lead to the vessel wall) which are necessarily determined and are considered guidance information configured to guide the implantable device extraction procedure based on the amount of adhesion. See also pg. 14 lines 21-26 which discloses The output 4 may also provide additional information. For example, the output 4 may be adapted for outputting the local curvature and/or the degree of local adhesion at the determined position of the extraction device. For example, advice may be provided for changing the extraction device. For example, information may be provided, e.g. displayed, 25 that relates to curvature ahead of the extraction device and/or to proximity of the lead to the vessel wall and pg. 14 lines 27-pg. 15 line 6 as well as pg. 17 lines 7-9)
Examiner notes that the system of Grass would further comprise the non-transitory computer-readable medium which cause the processor(s) to perform the corresponding functions of claim 16 and would perform the method of claim 17 having corresponding method steps.
Regarding claims 2 and 18,
Grass further discloses wherein to determine the amount of adhesion between the implantable device and the tissue contacting the implantable device, the one or more processor are further configured to:
Determine a Hounsfield unit attenuation value of the tissue contacting the implantable device ( pg. 10 lines 1-5 which discloses the 3D image volume may comprise an image volume representative of a segmentation of the lead, e.g. in which the presence or absence of the lead at each voxel location is encoded in the voxel values. And pg. 10 lines 15-20 which discloses The pre-processor 5, further
discussed hereinbelow, may be adapted for segmenting the lead from the image volume or
image volumes to provide the 3D image volume in which the lead is segmented from 3D
image data. The pre-processor 5 may be adapted for fitting a 3D model, e.g. a parametric 3D
model, to the segmented 3D image of the lead. Examiner notes that such segmentation of the lead and/or 3D image data necessarily requires determination of a Hounsfield unit attenuation value (i.e. voxel value from CT image data); and
determine the amount of adhesion between the implantable device and the tissue contacting the implantable device based on the Hounsfield Unit attenuation value (pg. 11 lines 4-20 which discloses the pre-processor 5 may be adapted for determining parameters of interest 5 from the segmented lead, e.g. from the 3D image volume in which the lead is segmented and/or based on the parametric 3D model. For example, a local curvature of the lead as function of a longitudinal position along the lead may be determined. For example, a degree of local adhesion of the lead tip, and/or of the lead as function of the longitudinal position along the lead, may be determined, thus using the segmented lead and therefore based on the Hounsfield Unit attenuation value (i.e. voxel value)).
Regarding claim 5,
Grass further discloses wherein to determine the amount of adhesion between the implantable device and the tissue contacting the implantable device, the one or more processors are further configured to analyze a plurality of positions along a length of the implantable device (pg. 11 lines 8-21 which discloses the preprocessor 5 may be adapted for determining the local adhesion of the lead to the wall of the body structure that contains the lead. For example, the 4D dataset may comprise a plurality of 15 3D images corresponding to a plurality of points in time extending over at least one cardiac cycle and/or at least one breathing cycle, such that the local motion of the lead relative to the vessel wall, induced by the natural motion of the body, can be quantified, in which regions of the lead which shows a large motion relative to the wall, e.g. a large variability of its position relative to the wall, are indicative of a low or no adhesion, and in which regions of the lead 20 which show a small motion relative to the wall are indicative of a high adhesion. Thus, the adhesion can be quantified or determined in a straight-forward manner)
Regarding claim 6,
Grass further discloses wherein the one or more processors are further configured to determine a total amount of adhesion between the implantable device and the tissue contacting the implantable device, based on the amount of adhesion between the implantable device and the tissue contacting the implantable device at the plurality of positions along the implantable device (pg. 11 lines 8-21 which discloses for example, the 4D dataset may comprise a plurality of 15 3D images corresponding to a plurality of points in time extending over at least one cardiac cycle and/or at least one breathing cycle, such that the local motion of the lead relative to the vessel wall, induced by the natural motion of the body, can be quantified, in which regions of the lead which shows a large motion relative to the wall, e.g. a large variability of its position relative to the wall, are indicative of a low or no adhesion, and in which regions of the lead 20 which show a small motion relative to the wall are indicative of a high adhesion. Thus, the adhesion can be quantified or determined in a straight-forward manner); and
Wherein the outputting guidance information for the implantable device extraction procedure, is based on the total amount of adhesion (pg. 14 lines 21-23 which discloses the output 4 may also provide additional information. For example, the output 4 may be adapted for outputting the local curvature and/or the degree of local adhesion at the determined position of the extraction device and pg. 17 lines 32-35 which discloses the parameter may comprise a degree of local adhesion. Examiner notes that any outputting of the adhesion at any position would necessarily be based on the total amount of adhesion determined).
Regarding claim 7,
Grass further discloses wherein the one or more processors are further configured to determine a value of a risk metric based on the attenuation data (pg. 3 lines 2-4 which discloses the processing unit is further adapted to determine a vessel and/or plaque characteristic at or near said determined position of said extraction device. Examiner notes that such a vessel or plaque characteristic is considered a risk metric in its broadest reasonable interpretation), the value of the risk metric representing a risk of damage to a tissue represented in the attenuation data (pg. 14 line 27 – pg. 15 line 15 which discloses vessel and/or plaque characteristics at (or near) the determined position of the extraction device may be determined from the 3D image data and after a region with hard plaque where a strong pressure needs to be applied to advance the extraction device and unexpected sudden advance of the cutting tip, once the hard plaque is passed could cause damage to the vessel. This can be advantageously avoided by automatically turning off the cutting device in regions with low adhesion, or after the characteristic sudden advance after a region with hard plaque).
And wherein the guidance information comprises an indication of the value of the risk metric (pg. 14 line 27-pg. 15 line 6 which discloses the parameter of the extraction device may be controlled by taking these characteristics into account. The power and/or wavelength of a laser extraction device, or the power of mechanical cutting device, may be controlled to be lower for soft plaque regions than for hard plaque regions, such an output of the parameter such as power, wavelength, etc. is considered an indication of the value of the risk metric)
Regarding claim 9,
Grass further discloses wherein the guidance information for the implantable device extraction procedure, comprises an indication of one or more of:
The amount of adhesion between the implantable device and a tissue contacting the implantable device (pg. 4 lines 19-22 which discloses output may be adapted for outputting the parameter corresponding to 20 a longitudinal position at or ahead of the determined position of the extraction device. This parameter may comprise a local curvature and/or a degree of local adhesion of the lead and/or a proximity of the lead to the vessel wall), an outcome metric for the implantable device extraction procedure (examiner notes that any of the output information is an outcome metric in its broadest reasonable interpretation), a recommended device setting for use in the implantable device extraction procedure, a recommended procedural step for use in the implantable device extraction procedure (pg. 17 lines 7-9 which discloses the at least one parameter of the extraction device may comprise a power setting and/or an on/off setting of the extraction device. This controlling 105 may comprise (e.g. temporarily) deactivating the extraction device when the detected position corresponds to a region of low adhesion of the lead to the vessel wall and/or a softer region after a hard plaque. See also pg. 14 lines 27 through pg. 15 lines 6)
Regarding claim 10,
Grass further discloses wherein to determine an amount of adhesion between the implantable device and the tissue contacting the implantable device, the one or more processors are further configured to quantify the amount of adhesion between the implantable device and the tissue contacting the implantable device with one or more adhesion classes, or adhesion scores (pg. 11 lines 8-21 which discloses The preprocessor 5 may be adapted for determining the local adhesion of the lead to the wall of the body structure that contains the lead. For example, the 4D dataset may comprise a plurality of 3D images corresponding to a plurality of points in time extending over at least one cardiac cycle and/or at least one breathing cycle, such that the local motion of the lead relative to the vessel wall, induced by the natural motion of the body, can be quantified, in which regions of the lead which shows a large motion relative to the wall, e.g. a large variability of its position relative to the wall, are indicative of a low or no adhesion, and in which regions of the lead which show a small motion relative to the wall are indicative of a high adhesion. Thus, the adhesion can be quantified or determined in a straight-forward manner).
Regarding claim 11,
Grass further discloses wherein the one or more processors are further configured to:
determine a presence of implantable device-induced inflammation in the anatomical region (pg. 3 lines 25-26 which discloses the processing unit may be adapted for determining a vessel and/or plaque characteristic at or near the determined position of the extraction device. Examiner notes that plaque is understood to be caused by inflammation, thus the determining of a characteristic of plaque and thus a presence thereof is considered the presence of inflammation including implantable device-induced inflammation) and
Output an indication of the presence of the implantable device-induced inflammation (pg. 3 lines 2-5 which discloses the processing unit is further adapted i) to determine a vessel and/or plaque characteristic at or near said determined position of said extraction device and ii) to control said at least one parameter of said extraction device by taking said characteristic into account. Examiner notes that such control requires outputting control information which is considered to be an indication of the presence of the implantable device-induced inflammation (e.g. an indication of the existence of the plaque).
Regarding claim 12,
Grass further discloses wherein the one or more processors are further configured to:
Determine a stability metric for the implantable device based on the attenuation data (pg. 11 which discloses the 4D dataset may comprise a plurality of 3D images corresponding to a plurality of points in time extending over at least one cardiac cycle and/or at least one breathing cycle, such that the local motion of the lead relative to the vessel wall, induced by the natural motion of the body, can be quantified, in which regions of the lead which shows a large motion relative to the wall, e.g. a large variability of its position relative to the wall, are indicative of a low or no adhesion, and in which regions of the lead which show a small motion relative to the wall are indicative of a high adhesion. Examiner notes that the variability in motion is considered a stability metric in its broadest reasonable interpretation); and
Output an indication of the stability metric (pg. 4 lines 16-22 which discloses the output may be adapted for outputting the parameter corresponding to a longitudinal position or ahead of the determined position of the extraction device. This parameter may comprise a local curvature and/or a degree of local adhesion of the lead and or a proximity of the lead to the vessel wall. The degree of local adhesion being an indication of the stability metric (i.e. variability in motion)).
Regarding claim 14,
Grass further discloses wherein the one or more processors are further configured to segment the received attenuation data to identify at least the implantable device, prior to analyzing the attenuation data (pg. 10 lines 15-17 which discloses the pre-processor 5, further discussed hereinbelow, may be adapted for segmenting the lead from the image volume or image volumes to provide the 3D image volume in which the lead is segmented from 3D image data)
Regarding claim 15,
Grass further discloses wherein the implantable device comprises a pacemaker lead, or an implantable cardioverter defibrillator lead, or a pacemaker, or an implantable cardioverter defibrillator, or an IVC filter (pg. 1 lines 27-29 which disclose It is an advantage of embodiments of the present invention to provide good, efficient and useful image guidance during a procedure of extracting an implanted lead(s), e.g. of a pacemaker or defibrillator and pg. 8 lines 23-25 which disclose during an extraction procedure for extracting at least one lead from the body of a subject, e.g. an implanted lead, e.g. a lead wire such as a conductive 25 wire of a pacemaker, a defibrillator, neurostimulator and/or an electric potential sensor)
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 3-4 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Grass in view of Zhao et al. (US 20210244374 A1), hereinafter Zhao.
Regarding claims 3 and 19,
Grass teaches the elements of claims 1 and 16 as previously stated. Grass further teaches wherien the attenuation data comprises spectral attenuation data, and wherein the spectral attenuation data defines the X-ray attenuation within the anatomical region (pg. 9 lines 27-30 which discloses the 3D image data may comprise multiple coregistered image volumes, e.g. multiple spectral CT image volumes)
Grass fails to explicitly teach wherein the spectral attenuation data defines the x-ray attenuation data within the anatomical region in a plurality of different energy intervals.
Zhao, in a similar field of endeavor involving X-ray imaging, teaches wherein attenuation data comprises spectral attenuation data, and wherein the spectral attenuation data defines x-ray attenuation within an anatomical region in a plurality of different energy intervals ([0104] which discloses the x-ray imaging apparatus and methods disclosed herein can be multi-energy and a multi energy system at each energy level (also known as spectral imaging, if the application requires the use of multiple energy x-ray imaging and analysis for material decomposition).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Grass to include spectral attenuation data as taught by Zhao in order to allow for material decomposition to be performed which would allow for characterization of a relative position and structure of a region of cardiac tissue where an implant exists to be performed with greater precision and/or to allow for differentiation of a heart valve implant based on multiple energy decomposition (Zhao [0592]-[0593]). Additionally/alternatively, such a modification amounts to merely a simple substitution of one known spectral attenuation data for another yielding predictable results with respect to cardiac implant imaging thereby rendering the claim obvious (MPEP 2143).
Regarding claims 4 and 20,
Grass, as modified, teaches the elements of claims 3 and 19 as previously stated. Grass, as currently modified, fails to explicitly teach wherein to determine an amount of adhesion between the implantable device and a tissue contacting the implantable device, the one or more processors are further configured to: apply a material decomposition algorithm to the spectral attenuation data to identify a type of tissue contacting the implantable device; and
Determine the amount of adhesion between the implantable device and the tissue contacting the implantable device based on the type of tissue.
Nonetheless, Zhao further teaches wherein one or more processors are configured to: apply a material decomposition algorithm to the spectral attenuation data to identify a type of tissue contacting an implantable device ([0025] which discloses the processor can be configured to output material decomposition analysis of the imaging subject having two or more materials. The material decomposition analysis can be based at least in part on a database of x-ray measurement properties of different materials).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Grass, as currently modified, to include applying a material decomposition algorithm to the spectral attenuation data as taught by Zhao in order to allow for characterization of a relative position and structure of a region of cardiac tissue where an implant exists to be performed with greater precision and/or to allow for differentiation of a heart valve implant based on multiple energy decomposition (Zhao [0592]-[0593]).
Examiner notes in the modified system the determination of the amount of adhesion between the implantable device and the tissue contacting the implantable device would be based on the segmentation/tracking of the implant which is enhanced due to the material decomposition of Zhao, therefore, the amount of adhesion is based on the result of the material decomposition in its broadest reasonable interpretation. Additionally/alternatively the amount of adhesion would be based on the type of tissue regardless (i.e. the type of tissue of which the implant is adhered) due to the breadth of “based on”.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Grass in view of WIPO Panse et al. (WO 2022128703 A1), hereinafter Panse.
Regarding claim 8,
Grass teaches the elements of claim 8 as previously stated. Gras further teaches wherein to determine an amount of adhesion between the implantable device and the tissue contacting the implantable device the one or more processor are further configured to:
Input the received attenuation data into a neural network (pg. 11 lines 1-3 which discloses the input may receive the 3D image data and the pre-processor may perform a machine learning based artefact removal using e.g. a trained convolutional neural network for metal artefacts and/or motion artefacts); and
Predicting, using the neural network, the amount of adhesion between the implantable device and a tissue contacting the implantable device (Examiner notes that the amount of adhesion is necessarily predicted using the neural network (e.g. using image data having artefacts removed by the neural network).
Grass fails to explicitly teach wherein the neural network is trained to predict the amount of adhesion between the implantable device and a tissue contacting the implantable device using training attenuation data comprising a plurality of training images representing the implantable device in an anatomical region, and ground truth data comprising ground truth adhesion values corresponding to the training images, the ground truth adhesion values representing the amount of adhesion between the implantable device and a tissue contacting the implantable device.
Panse, in a similar field of endeavor involving X-ray evaluation of Implant adhesion, teaches wherein a neural network is trained to predict an amount of adhesion between an implantable device and a tissue contacting the implantable device (pg. 4 lines 6-12 which discloses the machine learning algorithm outputs an adherence level and pg. 16 lines 15-17 which discloses examples of machine learning algorithms include artificial neural networks) using training attenuation data comprising a plurality of training images representing the implantable device in an anatomical region, and ground truth data comprising ground truth adhesion values corresponding to the training images, the ground truth adhesion values representing the amount of adhesion between the implantable device and a tissue contacting the implantable device (pg. 14 lines 25-30 which discloses the training data used to train the machine learning algorithm 302 consists of motion vectors 202 of the implanted lead 104, motion vectors of blood vessels in which the leads 104 are commonly implanted and the ground truth (i.e. is the lead 104 adhered to the blood vessel 102… the ground truth can be obtained from pre-operational CT images (i.e. training images)).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Grass to include a neural network as taught by Panse in order to provide an improved method of determining the adhesion of the lead inside a blood vessel (Panse pg. 2 lines 23-25).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Grass in view of NPL Holm et al. (“Algorithm for the analysis of pre-extraction computed tomographic images to evaluate implanted lead-lead interactions and lead-vascular attachments”), hereinafter Holm.
Regarding claim 13,
Grass teaches the elements of claim 12 as previously stated. Grass fails to explicitly teach wherein the one or more processors are further configured to:
Calculate a recommended length of the implantable device to be extracted in the implantable device extraction procedure, the recommended length being calculated based on at least one of the amount of adhesion between the implantable device and a tissue contacting the implantable device, the stability metric, or a presence of implantable device-induced inflammation; and
Output an indication of the recommended length.
Holm, in a similar field of endeavor involving x-ray evaluation of implants and adhesion thereof, teaches one or more processors configured to:
calculate a recommended length of an implantable device to be extracted in the implantable device extraction procedure, the recommended length being calculated based on at least one of an amount of adhesion (pg. 1013 which discloses the length of each lead was averaged across the 30 leads analyzed. The average lengths of red and yellow zones were also recorded. See also pg. 1014 results which discloses the average lead length was 69.8 +- 14.9 mm and the length of the red zone was 1.9 +-1.7 mm and the length of the yellow zones was 1.3 +-1.2 mm and pg. 1013 which discloses red zones represent lead-vessel adherence, yellow zones indicate possible adherence and green zones represent no lead vessel adherence); and
Output an indication of the recommended length (See table 1).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Grass to include calculating a recommended length as taught by Holm in order to provide a user with additional information regarding the amount of adhesion. Such a modification would allow a user to readily recognize how much of the lead is implanted as well as how much of the lead exhibits adhesion or possible adhesion.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE L KLEIN whose telephone number is (571)270-5204. The examiner can normally be reached Mon-Fri 7:30-4.
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/BROOKE LYN KLEIN/Primary Examiner, Art Unit 3797
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