DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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 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.
3. The following office action is a Final Office Action in response to the communications received on 01/20/2026.
Claims 1, 5, 9, 17 and 19 have been amended; claims 2 and 10 have been canceled. Therefore, claims 1, 3-9 and 11-23 are currently pending in this application.
Claim Rejections - 35 USC § 112
4. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
● Claims 1, 3-9 and 11-23 are rejected under 35 U.S.C.112(a) or 35 U.S.C.112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
(a) Each of claims 1, 9 and 17 currently recites that the “removable or integrated” marker, which comprises a post with a spherical tip, is “spaced away from an interior surface of the phantom” (emphasis added).
In contrast, per the original disclosure, the marker itself is already a post or protrusion—such as, a post with a spherical tip; and it is essentially attached to the interior surface of the phantom (e.g., see [0014] and [0021] of the specification, emphasis added),
“. . . the phantom object may further include markers (e.g., posts or protrusions) that may represent an anatomical target”
“. . . the markers 114 may be posts with a spherical tip. The markers 114 may be removable or integrated within the phantom object”
Accordingly, the current claims still involve new subject matter since the original disclosure does not have support regarding the claimed removable or integrated marker—namely, a post with a spherical tip—that is spaced away from an interior surface of the phantom object (also see FIG 1B, label “114”).
(b) In addition, per each of claims 5, 13 and 19, the marker above is considered to have one or more markers.
However, the original disclosure does not have any written description regarding such marker that comprises additional/multiple markers. Consequently, each of claims 5, 13 and 19 incorporates further new matter.
Note that, when an amendment is filed in reply to an objection or rejection based on 35 U.S.C. 112, first paragraph, a study of the entire application is often necessary to determine whether or not "new matter" is involved. Applicant should therefore specifically point out the support for any amendments made to the disclosure (see MPEP 2163.06).
► Applicant’s arguments directed to section §112(a) have been fully considered (the arguments filed on 01/20/2026). In particular, while referring to the previously presented limitation, “fixed physical marker”, Applicant is asserting that “claim 1 is amended . . . ’with a removable or integrated marker comprising a post with a spherical tip positioned within an interior area and the marker spaced away from an interior surface of the phantom object based on the sensor data.’ Claims 13 and 19 are amended to recite similar features. Applicant submits that amended claims 1, 13, and 19 are supported at, for example, at paragraph [0021] of the present application” (emphasis added).
However, the issue raised under section §112(a) is not due to the fixed and/or physical nature of the marker; rather, the issue is due to the term “spaced away”, which attempts to specify the position of the marker with respect to the “interior surface” of the phantom object. In particular, per the original disclosure, the marker is itself the post with a spherical tip; and this marker is attached to the “interior surface” of the phantom object (see [0014] and [0021] of the specification, “the markers 114 may be posts with a spherical tip”, emphasis added).
Thus, given such structural configuration—namely, the physical attachment of the marker to the “interior surface” of the phantom object, the “marker” is not considered to be “spaced away” from the “interior surface” of the phantom object. Of course, (a) the “marker” may be considered to be extending from the “interior surface” of the phantom object, or (b) the “spherical tip” of the “marker” may be considered to be “spaced away” from the “interior surface”; however, the “marker” itself is not “spaced away” from the “interior surface” since it appears to be physically attached to it (since the post itself is the marker per the specification). Consequently, Applicant’s arguments directed to section §112(a) are not persuasive.
Claim Rejections - 35 USC § 103
5. 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 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating
obviousness or nonobviousness.
Note that the one or more citations (paragraphs or columns) presented in this office action regarding the teaching of a cited reference(s) are exemplary only. Accordingly, such citation(s) are not intended to limit/restrict the teaching of the reference(s) to the cited portion(s) only. Applicant is required to evaluate the entire disclosure of each reference; such as additional portions that teach or suggest the claimed limitations.
● Claims 1, 3-9 and 11-23 are rejected under 35 U.S.C.103 as being unpatentable over Lu 2018/0256056 in view of Hemphill 2007/0166681 and in view of Toly 2005/0181342.
Regarding claim 1, Lu teaches the following limitations: a computer-implemented method comprising: detecting a medical instrument within a phantom object based on sensor data captured by one or more sensors implemented within and inside of an outer surface of the phantom object ([0049]; [0050]; [058]: e.g. a computer-based simulation system for practicing a medical procedure(s); and the system comprises at least one organ model— FIG 5, label “122”—and one or more sensors—FIG 4, label “124”—positioned within the organ model; and the sensor detects a medical instrument—such as a catheter—that is being manipulated during the simulation of a medical procedure. In this regard, the organ model corresponds to the phantom object); measuring a distance between the medical instrument and a target point associated with a removable or integrated marker positioned within an interior area and the marker spaced away from an interior surface of the phantom object based on the sensor data; and storing or outputting information identifying the distance between the medical instrument and the target point ([0050]; [0064] to [0066]; [0068]: e.g. during a simulated medical procedure, the user manipulates the medical instrument—such as the catheter—inside the organ model; such as, the user attempts to make contact with part of the inner wall of the organ model, etc. Note also that the inner wall or surfaces of the above organ model—FIG 5, label “122”—is already lined with the sensor mesh—FIG 4, label “124”. It is understood that the sensor mesh already comprises an upper/top surface, which is spaced away from the inner surface of the organ model. This is because the sensor mesh is in the form of a matrix that involves multiple layers of lines, and wherein the layers are separated by an insulating sheet. Thus, the sensor mesh, which also represents a removable or integrated marker, involves an upper/top portion that is spaced away from an interior surface of the phantom object. Accordingly, the sensors detect the location/position of the catheter within the organ model; and thereby the system generates/displays, based on the analysis of the detected data, one or more corresponding simulation scenarios—i.e., the system stores or outputs information identifying the distance between the medical instrument and the target point. In this regard, one or more parts of the organ model, such as part of its inner wall, corresponds to the target point. It is also worth to note that the organ model, such as the heart model, already comprises one or more parts that simulate the left atrium, the right atrium, the left ventricle and the right ventricle).
Lu does not describe that the marker above comprises a post with a spherical tip; however, Toly teaches a simulation system for training medical procedures; wherein the system comprises a model/manikin, which incorporates—in its internal cavity—a post with a spherical tip (e.g., FIG 4, label “20”); and wherein the post serves as a target that a trainee attempts to reach when conducting a simulated procedure ([0064]).
Accordingly, given the above teaching, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the invention of Lu in view of Toly; for example, by incorporating one or more detachable posts at one or more desired positions, wherein a corresponding detection unit is also incorporated with respect to each post; so that, the user would have further opportunity to learn techniques for properly identifying one or more additional targets that mimic abnormal growth—such as a tumor—that may develop on the walls of an organ, etc.
Lu also does not expressly describe that the sensor(s), which are implemented within and inside of an outer surface of the phantom object, comprise one or more cameras that capture video/mage.
However, Hemphill teaches a simulation system for practicing a medical procedure(s); the system incorporates one or more organ models; and wherein, one or more cameras are embedded within the organ model in order to capture images during the procedure ([0024]; [0027]).
It is also worth to note that Lu already teaches the implementation of one or more cameras to capture image data during simulation; wherein the system analyzes the image data to calculate, based on evaluating the pixels relevant to the medical instrument, the positions of the of the medical instrument within the organ model ([0051]; [0075] to [0078]).
Accordingly, given the above teaching, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the intervention of Lu in view of Hemphill; for example, by incorporating one or more additional sensors inside the physical organ/heart model; such as, one or more compact cameras and light sources (e.g., LEDs), etc., so that the system further analyzes the images captured from the above cameras in order to verify the accuracy of the positions of the medical instrument during the procedure; for example, based on the evaluation of the pixels that are relevant to the instrument and the target(s) within the organ model, etc.; and wherein, such modification improves the overall accuracy of the system.
Regarding claim 9, Lu teaches the following claimed limitations: a computer program product comprising a computer readable storage medium having program instructions embodied therewith ([0049]: a computer-based simulation system for practicing a medical procedure(s); wherein the system comprises various components, including a controller in the form of a computer that comprises a processor and a memory), the program instructions executable by a computing device to cause the computing device to perform operations comprising: detecting a medical instrument within a phantom object based on sensor data captured by one or more sensors implemented within and inside of an outer surface of the phantom object ([0049]; [0050]; [058]: e.g. a computer-based simulation system for practicing a medical procedure(s); and the system comprises at least one organ model— FIG 5, label “122”—and one or more sensors—FIG 4, label “124”—positioned within the organ model; and the sensor detects a medical instrument—such as a catheter—that is being manipulated during the simulation of a medical procedure. In this regard, the organ model corresponds to the phantom object); measuring a distance between the medical instrument and a target point associated with a removable or integrated marker positioned within an interior area and spaced away from an interior surface of the phantom object based on the sensor data; and storing or outputting information identifying the distance between the medical instrument and the target point ([0050]; [0064] to [0066]; [0068]: e.g. during a simulated procedure, the user manipulates the instrument—such as the catheter—inside the organ model; such as, the user attempts to make contact with part of the inner wall of the organ model, etc. The inner wall or surfaces of the above organ model—FIG 5, label “122”—is already lined with the sensor mesh—FIG 4, label “124”. It is understood that the sensor mesh already comprises an upper/top surface, which is spaced away from the inner surface of the organ model. This is because the sensor mesh is in the form of a matrix that involves multiple layers of lines, and wherein the layers are separated by an insulating sheet. Thus, the sensor mesh, which also represents a removable or integrated marker, involves an upper/top portion that is spaced away from an interior surface of the phantom object. Accordingly, the sensors detect the location/position of the catheter within the organ model; and thereby the system generates/displays, based on the analysis of the detected data, one or more corresponding simulation scenarios—i.e., the system stores or outputs information identifying the distance between the medical instrument and the target point. In this regard, one or more parts of the organ model, such as part of its inner wall, corresponds to the target point. It is also worth to note that the organ model, such as the heart model, already comprises one or more parts that simulate the left atrium, the right atrium, the left ventricle and the right ventricle).
Lu does not describe that the marker above comprises a post with a spherical tip; however, Toly teaches a simulation system for training medical procedures; wherein the system comprises a model/manikin, which incorporates—in its internal cavity—a post with a spherical tip (e.g., FIG 4, label “20”); and wherein the post serves as a target that a trainee attempts to reach when conducting a simulated procedure ([0064]).
Accordingly, given the above teaching, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the invention of Lu in view of Toly; for example, by incorporating one or more detachable posts at one or more desired positions, wherein a corresponding detection unit is also incorporated with respect to each post; so that, the user would have further opportunity to learn techniques for properly identifying one or more additional targets that mimic abnormal growth—such as a tumor—that may develop on the walls of an organ, etc.
Lu also does not expressly describe that the sensor(s) above, which are implemented within and inside of an outer surface of the phantom object, comprise one or more cameras that capture video/mage.
However, Hemphill teaches a simulation system for practicing a medical procedure(s); the system incorporates one or more organ models; and wherein, one or more cameras are embedded within the organ model in order to capture images during the procedure ([0024]; [0027]).
It is also worth to note that Lu already teaches the implementation of one or more cameras to capture image data during simulation; wherein the system analyzes the image data to calculate, based on evaluating the pixels relevant to the medical instrument, the positions of the of the medical instrument within the organ model ([0051]; [0075] to [0078]).
Accordingly, given the above teaching, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the intervention of Lu in view of Hemphill; for example, by incorporating one or more additional sensors inside the physical organ/heart model; such as, one or more compact cameras and light sources (e.g., LEDs), etc., so that the system further analyzes the images captured from the above cameras in order to verify the accuracy of the positions of the medical instrument during the procedure; for example, based on the evaluation of the pixels that are relevant to the instrument and the target(s) within the organ model, etc.; and wherein, such modification improves the overall accuracy of the system.
Regarding claim 17, Lu teaches the following claimed limitations: a system comprising: a phantom object comprising a removable or integrated marker positioned within an interior area and spaced away from an interior surface of the phantom object; one or more sensors within and inside of an outer surface of the phantom object (see FIG 5, labels “122”, “124”; [0066]: e.g. a computer-based simulation system is depicted, wherein the system comprises an organ model, label “122”, which corresponds to the phantom object; and at least one sensor—label “124”—positioned inside and/or within the phantom object. In this regard, the sensor mesh—FIG 4, label “124”—above already lines the inner wall or surfaces of the above organ model. It is understood that the sensor mesh already comprises an upper/top surface, which is spaced away from the inner surface of the organ model. This is because the sensor mesh is in the form of a matrix that involves multiple layers of lines, and wherein the layers are separated by an insulating sheet. Thus, the sensor mesh, which also represents a removable or integrated marker, involves an upper/top portion that is spaced away from an interior surface of the phantom object); and a processor, and a non-transitory computer readable storage medium associated with a computing device in communication with the phantom object ([0049]: e.g., the system is already a computer-based simulation system, which comprises various components, including a controller in the form of a computer that comprises a processor, a memory, etc. Thus, the system already comprises basic computer components, including a processor, a non-transitory computer readable storage/memory that stores computer executable instructions, etc.), and program instructions executable by the computing device to cause the computing device to perform operations comprising: detecting a medical instrument within the phantom object based on sensor data captured by the one or more sensors ([0049]; [0050]; [058]: e.g. the system already comprises at least one organ model— FIG 5, label “122”—and one or more sensors—FIG 4, label “124”—positioned within the organ model; and the sensor detects a medical instrument—such as a catheter—that is being manipulated during the simulation of a medical procedure); measuring a distance between the medical instrument and a target point associated with the marker based on the sensor data; and storing or outputting information identifying the distance between the medical instrument and the target point ([0050]; [0064] to [0066]; [0068]: e.g. during a simulated procedure, the user manipulates the instrument—the catheter—inside the organ model; such as, the user attempts to make contact with part of the inner wall of the organ model, etc., and the sensors detect the location/position of the catheter within the organ model; and thereby the system generates/displays, based on the analysis of the detected data, one or more corresponding simulation scenarios., i.e. the system stores or outputs information identifying the distance between the medical instrument and the target point. In this regard, one or more parts of the organ model, such as part of its inner wall, corresponds to the target point; and wherein, this target point is already associated with the sensor mesh, which is also the marker. It is also worth to note that the organ model, such as the heart model, already comprises one or more parts that simulate the left atrium, the right atrium, the left ventricle and the right ventricle).
Lu does not describe that the marker above comprises a post with a spherical tip; however, Toly teaches a simulation system for training medical procedures; wherein the system comprises a model/manikin, which incorporates—in its internal cavity—a post with a spherical tip (e.g., FIG 4, label “20”); and wherein the post serves as a target that a trainee attempts to reach when conducting a simulated procedure ([0064]).
Accordingly, given the above teaching, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the invention of Lu in view of Toly; for example, by incorporating one or more
detachable posts at one or more desired positions, wherein a corresponding detection unit is also incorporated with respect to each post; so that, the user would have further opportunity to learn techniques for properly identifying one or more additional targets that mimic abnormal growth—such as a tumor—that may develop on the walls of an organ, etc.
Lu also does not expressly describe the sensor(s) above, which are within and inside of an outer surface of the phantom object, comprise one or more cameras that capture video/mage.
However, Hemphill teaches a simulation system for practicing a medical procedure(s); wherein the system incorporates one or more organ models; and wherein, one or more cameras are embedded within the organ model in order to capture images during the procedure ([0024]; [0027]).
Note also that Lu already teaches the implementation of one or more cameras to capture image data during simulation; wherein the system analyzes the image data to calculate, based on evaluating the pixels relevant to the medical instrument, the positions of the of the medical instrument within the organ model ([0051]; [0075] to [0078]).
Accordingly, given the above teaching, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the intervention of Lu in view of Hemphill; for example, by incorporating one or more additional sensors inside the physical organ/heart model; such as, one or more compact cameras and light sources (e.g., LEDs), etc., so that the system further analyzes the images captured from the above cameras in order to verify the accuracy of the positions of the medical instrument during the procedure; for example, based on the evaluation of the pixels that are relevant to the instrument and the target(s) within the organ model, etc.; and wherein, such modification improves the overall accuracy of the system.
Regarding claims 3, 11 and 22, Lu in view of Toly and in view of Hemphill teaches the claimed limitations as discussed above per each of claims 1, 9 and 17.
The limitation, “the detecting of the medical instrument is based on image or pixel-based classification of the video or image data”, is already addressed per the modification discussed with respect to each of claims 1, 9 and 17.
Particularly, the modified system analyzes the images captured from the above cameras in order to verify the accuracy of the positions of the medical instrument during the procedure; for example, based on the evaluation of the pixels that are relevant to the instrument and the target(s)—such as the wall—within the organ model (e.g., the system detects the spatial position of the instrument—such as the catheter—based on its direction angle and shape image from the viewpoint of the cameras, including determining pixels having the distinctive attribute—such as color—or the catheter, etc.).
Lu in view of Toly and in view of Hemphill teaches the claimed limitations as discussed above per each of claims 1, 9 and 17. Lu further teaches:
Regarding claims 4 and 12, detecting the target point, wherein the measuring the distance between the medical instrument and the target point is based on the detecting the target point ([0064]; [0065]; [0068]; [0075] to [0078]: e.g., as already discussed per each of claims 1 and 9, the system detects the location/position of the catheter within the organ model as user is performing a simulated medical procedure by manipulating the catheter inside the organ model; and thus, such measurement of the location/position of the catheter with respect to one or more parts—such as the inner wall—of the organ model, already indicates that the system measures the position/location of the catheter based on detecting the target point. Note also that the organ/heart model, already comprises one or more parts that simulate the left atrium, the right atrium, the left ventricle and the right ventricle).
Regarding claims 5, 13 and 19, Lu in view of Toly and in view of Hemphill teaches the claimed limitations as discussed above per claims 4, 12 and 17 respectively.
Although Lu does not expressly teach, detecting the target points comprises at least one selected from the group consisting of: detecting one or more markers of the marker implemented within the phantom object from the sensor data; and receiving user input identifying the target location from the sensor data (as claimed per each of claims 5 and 13); or the marker comprises one or more markers used to define the target point (as claimed per claim 19), Toly already teaches a further option for placing a marker in a target region; and the marker comprises one or more markers—e.g., a barcode—that is detectable via a camera ([0066]).
It is worth to note that Lu already implements a marker—such as a red color—on the tip of the medical instrument, so that the cameras easily identify the position of the catheter ([0076]).
Accordingly, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the invention of Lu in view of Toly; for example, by incorporating at least one marker comprising at least one distinctive barcode—or color—detectable via the cameras; and wherein the at least one marker is associated with a corresponding part of the organ model (e.g. considering the exemplary heart model—see FIG 4 or FIG 5, label “122” —a corresponding physical marker would be associated with respect to each of: the left atrium, the right atrium, the left ventricle and the right ventricle, etc.), so that the cameras would be able to easily distinguish—during one or more simulated medical procedures—one or more parts of the anatomical model, besides distinguishing the particular instrument (e.g. the catheter) that the user is manipulating, etc., so that one or more of the results that the system is generating (e.g. position/location data of a medical instrument(s) with respect to one or more parts of the model, etc.) would be more refined and/or reliable.
Lu in view of Toly and in view of Hemphill teaches the claimed limitations as discussed above per each of claims 1, 9 and 17. Lu further teaches:
Regarding claims 6 and 18, wherein the phantom object is a replica of an organ and the medical instrument is a catheter or needle or replica of a catheter or needle ([0050]; [0053]: e.g., the phantom already a replica of an organ—such as the heart; and wherein the medical instrument is at least a catheter);
Regarding claim 7, 15, and 23, a synthetic medical image is generated based on some combination of the phantom object geometry, relevant anatomical features, and the identified target location ([0064]; [0065]: e.g. based on the manipulations that the user is performing using the catheter, the system displays one or more simulated images that represent one or more scenarios—such as, contact locations to form lesions; the current location of the catheter in the heart model; the locations of sites of interest; effects of performing ablations of various portions of the simulated heart, etc. Accordingly, one or more of the above scenarios already indicate that the system generates one or more synthetic medical images based on some combination of the phantom object geometry, relevant anatomical features, and the identified target location);
Regarding claims 8 and 16, the distance between the medical instrument and the target point is measured during a training procedure or a procedure to evaluate performance of a system used to guide insertion of the medical instrument ([0064]; [0065]; [0068]; [0075] to [0078]: e.g. when performing a simulated medical procedure, the user manipulates the medical instrument—such as the catheter—inside the anatomical model;, and one or more of the sensors—including the cameras—detect the location/position of the catheter within the anatomical model, so that the system displays one or more scenarios based on the measured position or location of the instrument within the anatomical model. Accordingly, the above indicates at least the distance between the medical instrument and the target point is measured during a training procedure, etc.);
Regarding claim 14, wherein the phantom object is a replica of an organ ([0050]: e.g., the phantom already a replica of an organ—such as the heart);
Regarding claim 20, the phantom object includes an inner compartment that can be filled with tissue-mimicking material ([0050]; [0051]: e.g., the organ mode, such as the physical heart model—FIG 4, label “122”—includes one or more chambers of the heart; and furthermore, it is formed from a material that is similar to living heart tissue. Thus, the phantom object already comprises an inner cavity that can be filled with one or more tissue-mimicking materials).
Regarding claim 21, Lu in view of Hemphill teaches the claimed limitations as discussed above per claim 17.
The limitation, “the phantom object comprising one or more internal lights to support sensing via the one or more cameras”, is already addressed per the modification discussed with respect to claim 17.
Particularly, the modified system already incorporates one or more compact cameras and light sources (e.g., LEDs), etc., so that the system further analyzes the images captured from the above cameras in order to verify the accuracy of the positions of the medical instrument during the procedure, etc. (also see the motivation discussed per claim 17 above since it also applies to claim 21).
Response to Arguments.
6. Applicant’s arguments have been fully considered (the arguments filed on 01/20/2026). However, the arguments are not persuasive at least for the following reasons:
Firstly, as evident from the obviousness analysis presented above, the combined teaching of Lu, Toly and Hemphill does teach each of the current claims; and therefore, each of claims 1, 9 and 17 is obvious over the prior art.
Secondly, while referring to one or the prior limitations, “measuring a distance between the medical instrument and a target point based on the sensor data”, Applicant is asserting that “the Office alleges that Lu, at paragraphs [0064], [0065], and [0068], teaches this feature . . . Lu uses either a sensor mesh or a position sensor in a catheter to track the catheter during the medical procedure . . . The sensor mesh is lined within the inner surface of the physical model . . . As a result, that the sensor mesh or the position sensor disclosed by Lu is not ‘associated with a removable or integrated marker comprising a post with a spherical tip positioned within an interior area and the marker spaced away from an interior surface of the phantom object,’ as recited in amended claim 1, and similarly recited in amended claims 9 and 17” (emphasis added).
However, it is unclear whether Applicant is attempting to address (i) a limitation that was presented in the past or (ii) the current claim amendment. This is because Applicant appears to be conflating two different limitations; namely, “measuring a distance between the medical instrument and a target point based on the sensor data” (e.g., see claims filed on 10/16/2024), and “measuring a distance between the medical instrument and a target point associated with a removable or integrated marker comprising a post with a spherical tip positioned within an interior area and the marker spaced away from an interior surface of the phantom object based on the sensor data” (i.e., the current claim amendment, emphasis added).
Nevertheless, regarding the earlier limitation, “measuring a distance between the medical instrument and a target point based on the sensor data”, one of the prior office actions already demonstrates the teaching of the prior art (e.g., the teaching of Lu) regarding the above limitation (e.g., see the office action dated 12/18/2024; pages 3 to 4).
Similarly, regarding the current claims, the current office action already establishes a new ground of rejection, which addresses the new limitation added per the current claim amendment (e.g., see section §103 above). Consequently, Applicant’s arguments directed to the current claim amendment are now moot in view of the new ground of rejection.
Note also that Applicant has not challenged the teaching of Toly as applied to the new limitation currently added. Nevertheless, the discussion presented per the obviousness analysis above (i.e., section §103) already points out relevant sections from the reference that teaches the newly added limitation.
Thus, at least for the reasons discussed above, the Office concludes that the current claims are still obvious over the prior art.
Conclusion
Applicant’s amendment necessitated the new grounds of rejection presented in this final 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 filled 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRUK A GEBREMICHAEL whose telephone number is (571) 270-3079. The examiner can normally be reached on 7:00AM-3:00PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, DAVID LEWIS can be reached on (571) 272-7673. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRUK A GEBREMICHAEL/Primary Examiner, Art Unit 3715