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 is a non-Final action in response to the preliminary amendment filed on 12/20/2024. Claims 1-10 have been amended; claim 11 has been canceled; and new claims 12 and 13 have been added. Thus, claims 1-10, 12 and 13 are currently pending in this application.
Drawings
4. The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because the figures (e.g., see FIG 12) do not include the reference sign “90” mentioned in the description (see page 21 of the specification, which denotes “90” as the tank).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended.
Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either "Replacement Sheet" or "New Sheet" pursuant to 37 CFR 1.121(d).
If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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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, 2, 4-7, 10, 12 and 13 are rejected under 35 U.S.C.103 as being unpatentable over Dodson 2020/0242973 in view of Krautim 2009/0110140.
Regarding claim 1, Dodson teaches the following claimed limitations: a training device for a surgical procedure of endovascular treatment of an aneurysm, comprising: a container having a wall defining a confined chamber and a first access opening in said wall ([0006]; FIG 1, label, “100”: e.g., a simulator for practicing a medical procedure; wherein the simulator comprises a heart model—label “100”, which has (i) a body—not labeled—that appears to have an oval/spherical shape, and also (ii) an aperture—not labeled—into which the male connector—FIG 1, label “111”—is connected. Thus, the oval shape body of the heart model corresponds to the claimed container, which has a wall defining a confined chamber; whereas the aperture on this body corresponds to the firs access opening), said first access opening being configured to allow the insertion into the container a guidewire and/or a guiding catheter for endovascular surgery, a first tube connected to said container at said first access opening ([0044]: e.g., the male connector—FIG 1, label “111”— is itself a tubular component connected to the aperture, which represents the first access opening; and accordingly, the above male connector represents the claimed first tube. Furthermore, a catheter, which a trainee passes through a port on the component—FIG 1, label “108”—that represents the inferior vena cava, eventually reaches the interior body of the model via the first access point. The above indicates that the first access opening is already configured to allow the insertion—into the container—a guidewire and/or a guiding catheter for endovascular surgery), a target is arranged within the container and comprises at least one cannulation site configured to receive said guidewire and/or said guiding catheter for endovascular surgery ([0033]; also FIG 2, label “106”: e.g., the heart model internally contains an insert that includes a target component; and thus, the insert and/or its target corresponds to the claimed target, which is configured to receive the guidewire and/or the guiding catheter for endovascular surgery).
Dodson does not teach a movable element or a control member is connected to the target; and said control member at least partially protrudes out of the container through a control opening of the wall of the container, and the movable element is movably constrained, at said control opening to the wall of the container to enable the target to adopt a plurality of different positions and/or orientations within the container.
It is worth nothing that the terms “movable element” and “control member” are representing the same component (e.g., see FIG 7, labels “70” and “74”).
Krautim teaches a simulator for a medical procedure; the simulator comprises a container in the form of lung (FIG 5A, label “583” or FIG 6A label “683”); wherein the simulator further comprises a movable target (FIG 5A, label “584”) positioned inside the container; the target is connected to movable element—or a control member—namely, a rod (FIG 5A, label “585”); and wherein part of the rod protrudes out of the container through a control opening—namely, a port (FIG 6A, label “687”)—of the wall of the container (note that the rod is already movably constrained at the port); and thereby, the rod enables the target to adopt a plurality of different positions and/or orientations within the container ([0037]).
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 Dodson in view of Krautim; for example, by cutting, via a surgical knife, one or more opening on one or more parts of the body—i.e., the container—of the heart model; wherein a movable rod is also incorporated; wherein the proximal end of the rod is fixedly or removably secured to the target—such as, via an attachment that allows the rod to move the target without the rod being disconnected from the target; whereas the distal end of the rod protrudes out of the container via one of the ports on the wall; so that the user, while manipulating the rod, would be able to easily position the target at one or more desired locations within the body of the heart model; and thereby, the system allows the user—or the user’s trainee (if any)—to easily vary the difficulty of the medical procedure being simulated by varying the position of the target within the body of the heart model, etc.
It is worth noting, per the teaching Krautim, that the simulation system is used to assess, at least implicitly, the performance of a radiation therapy that the user is delivering, while positioning the target at different positions within the body of the lung model ([0025]; [0041]). Similarly, the modification applied to Dodson enables the user to evaluate the consistency of his/her performance while positioning the target at different positions within the body of the heart model.
Regarding claim 2, Dodson in view of Krautim teaches the claimed limitations as discussed above per claim 1.
Dodson further teaches, said container has a spherical or ovoid shape (FIG 1, label “100”: e.g., the body of the heart model, which is the container, already has an ovoid or spherical shape).
Regarding claim 4, Dodson in view of Krautim teaches the claimed limitations as discussed above per claim 1.
Krautim further teaches, one or more of the at least one cannulation site, the target and the movable element is made of a radiopaque material ([0024]: e.g., the organ model, which is in the form of a human lung, is considered to be realistic in radiographical action and composition; and this suggests that one or more of its features, such as the cannulation site, is made of a radiopaque material).
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 invention of Dodson in view of Krautim; for example, by implementing one or more features of the simulator—such as the target and/or the cannulation site—with a radiopaque material; so that the user would be able to simulate one or more additional procedures; such as, a procedure that requires (i) visualizing—via an X-ray—the particular site being operated, and/or (ii) performing a radiation therapy to treat a condition at a particular site, etc., so that the user would have a further opportunity to expand his/her skills.
Regarding claim 5, Dodson in view of Krautim teaches the claimed limitations as discussed above per claim 1.
Dodson further teaches, the at least one cannulation site is sectioned among one or more cavities, one or more concave regions, one or more recesses or one or more through holes in said target ([0035]; [0044]: e.g., the hear model already incorporates various components, including the right atrium component and the left atrium component; and wherein the trainee performs a procedure by inserting a catheter that reaches each of the above components. The above indicates that the cannulation site, which is one or more internal parts of the heart where the catheter is being inserted and/or manipulated, is at least one of site is sectioned among one or more cavities, one or more concave regions, one or more recesses).
Regarding claim 6, Dodson in view of Krautim teaches the claimed limitations as discussed above per claim 1.
The limitation, “the control opening is an elongated cut or slit in the wall of the container, said cut or said slit comprising flexible edge faps, and wherein the movable element is kept reversibly constrained to the wall of the container by a friction of said flexible edge flaps of said cut or of said slit onto the control member”, is referring to the inherent attributes of an organ model that is modeled to mimic the physical attributes of a real tissue.
In this regard, Dodson already teaches that the heart model is made of a suitable material—or a combination of materials—that provide a more realistic simulation (e.g., see [0045] lines 1-20). This already confirms that Dodson’s heart already simulates the physical characteristics of a real tissue.
Moreover, per the modification applied to Dodson (see the modification discussed per claim 1 above), at least one opening is cut on the body of the heart model in order to insert the rod that moves the target. Accordingly, such opening inherently creates flaps (e.g., the edges of the cut) that frictionally engages the rod (or any other instrument) that is passing through the cut; and thus, the rod is effectively reversibly constrained to the wall of the heart model due to the above inherent attribute.
Thus, the modification discussed per claim 1 already addresses the inherent attribute that claim 6 is reciting (note that the discussion presented regarding claim 1 also applies to claim 6 since claim 6 is dependent on claim 1).
Regarding claim 7, Dodson in view of Krautim teaches the claimed limitations as discussed above per claim 1.
The limitation, “the control member of the movable element is rigidly fixed to the target or is made as one piece with the target”, is already addressed per the modification discussed with respect to claim 1. In particular, the proximal end of the rod is fixedly secured to the target via an attachment that allows the rod to move the target without the rod being disconnected from the target; and accordingly, the control member of the movable element is at least rigidly fixed to the target (also see the motivation discussed with respect to claim 1 since it also applies to claim 7).
Regarding claim 10, Dodson teaches the following claimed limitations: a training method for a surgical procedure of endovascular treatment of aneurysms ([0006]; [0044] lines 1-4: e.g., a simulation system that comprises a heart model for practicing surgical procedures—such as, endovascular treatment of aneurysms).
Dodson, as modified per Krautim (see the modification discussed per claim 1), further teaches: providing the training device according to claim 1 (see the discussion presented above with respect to claim 1 since it also applies to claim 10): providing a guidewire for endovascular surgery and/or a guiding catheter for endovascular surgery; introducing said guidewire, or said guiding catheter, or said guidewire introduced in said guiding catheter, into the container of the device through said first tube and said access opening (see [0044] lines 1-11: e.g., the heart model, FIG 1 label “100”, has an aperture—not labeled—where the male connector—label “111”—is connected, and this aperture represents the access opening, whereas the male connector is the first tube. Accordingly, in order to reach the internal body of the heart model, trainee first inserts the catheter into a tubular component—label “108”—that is already connected to the male connector [i.e., first tube], so that the catheter gets into the heart model via the access opening); attempting to direct a terminal end of the guidewire and/or an ending of the guiding catheter towards the cannulation site of the target of the movable element ([0044] lines 11-24: e.g., the trainee manipulates the catheter to reach the desired site—such as, “maneuver the catheter up through inferior vena cava component 108 and into right atrium component 101”, etc. Thus, the trainee is indeed directing the ending of the guiding catheter towards the cannulation site of the target of the movable element. Note that given the modification discussed per claim 1, the target is already attached to the movable element).
Regarding claim 12, Dodson in view of Krautim teaches the claimed limitations as discussed above per claim 1.
Although Krautim suggests that at least a cannulation site is made of a radiopaque material ([0024]), the combined teaching does not expressly suggest that one or more of the at least one cannulation site, the target, and the movable element is made of a metallic radiopaque material.
However, Applicant already admits the prior art, which already teaches targets that typically made of metallic radiopaque material— such as, endoprostheses commonly used in endovascular procedures (e.g., see page 2 to 3 of the specification).
Accordingly, given the above teaching of the prior art, 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 Dodson’s system by incorporating one or more targets well-known in the art—such as, one or more endoprostheses that are typically made of metallic radiopaque material; and wherein the user places, based on the teaching gleaned from Krautim, at least one such endoprostheses into the heart model; so that the user would have a further opportunity to practice one or more additional endovascular procedures that require the user of radiation—such as, tracking the motion of target via X-ray imaging, etc.
Regarding claim 13, Dodson teaches the following claimed limitations: a training method for a surgical procedure of endovascular treatment of aneurysms ([0006]; [0044] lines 1-4: e.g., a simulation system that comprises a heart model for practicing surgical procedures—such as, endovascular treatment of aneurysms).
Dodson, as modified per Krautim (see the modification discussed per claim 1), further teaches: providing the training device according to claim 1 (see the discussion presented above with respect to claim 1 since it also applies to claim 10): providing a guidewire for endovascular surgery and/or a guiding catheter for endovascular surgery; introducing said guidewire, or said guiding catheter, or said guidewire introduced in said guiding catheter, into the container of the device through said first tube and said access opening (see [0044] lines 1-11: e.g., the heart model, FIG 1 label “100”, has an aperture—not labeled—where the male connector—label “111”—is connected, and this aperture represents the access opening, whereas the male connector is the first tube. Accordingly, in order to reach the internal body of the heart model, trainee first inserts the catheter into a tubular component—label “108”—that is already connected to the male connector [i.e., first tube], so that the catheter gets into the heart model via the access opening); attempting to direct a terminal end of the guidewire and/or an ending of the guiding catheter towards the cannulation site of the target of the movable element; and introducing said terminal end of the guidewire and/or said ending of the guiding catheter into the cannulation site of the target ([0044] lines 11-24: e.g., the trainee not only inserts and/or manipulates the catheter to reach the desired site, but also performs a desired procedure once reaching the desired site —such as, “maneuver the catheter up through inferior vena cava component . . . manipulating the catheter and the cutting instrument “to pierce the transseptal wall at a desired point in or adjacent to the area of the fossa ovalis to allow the catheter to be inserted further to reach the chamber defined by left atrium component”, etc. Thus, the trainee not only directs an ending of the guiding catheter towards the cannulation site of the target of the movable element, but also introduces the ending of the guiding catheter into the cannulation site of the target. Here also, it is worth noting—per the modification discussed with respect to claim 1—that the target is already attached to the movable element).
● Claims 3 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Dodson 2020/0242973 in view of Krautim 2009/0110140 and in view of Okayama 2019/0244544.
Regarding claim 3, Dodson in view of Krautim teaches the claimed limitations as discussed above per claim 1.
Dodson, as modified above, does not expressly teach that the wall of said container is made of a translucent or transparent material.
However, Okayama teaches a simulation system that comprises a heart model (see FIG 2 label “30”) that has an oval or spherical body (FIG 2, label “30A”); and the heart model is made of a transparent material in order to enable the user view the medical instrument (e.g., a catheter) that the user is manipulating during a simulated procedure ([0034]).
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 invention of Dodson in view of Okayama; for example, by providing a further option of a heart model made of a transparent material; so that the user would have a better chance to learn the medical procedure by observing the manner in which he/she is manipulating the medical instrument (and/or target) when performing one or more simulated medical procedures.
Regarding claim 9, Dodson in view of Krautim teaches the claimed limitations as discussed above per claim 1.
Although Dodson further teaches a tank having a perimeter wall (FIG 11, label “172”), Dodson does not expressly teach that the tank above has a height such as to contain a fluid column capable of completely covering said container of the device arranged in immersion in said tank.
However, Okayama already taches a simulator system that comprises a heart model (FIG 1/FIG 2, label “30”); wherein the simulator further comprises a tank (FIG 1, label “10”) filled with liquid; and wherein the heart mode is submerged in the liquid, so that the trainee obtains “a feeling that more closely resembles an actual clinical condition at the time of catheter operation” ([0025]; [0030] to [0032]).
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 invention of Dodson in view of Okayama; for example, by incorporating a tank capable of submerging the heart model; wherein the tank is filled with relevant fluid while the heart model is securely positioned in the tank; so that the arrangement provides the user with a more realistic medical procedure that further enhances the user’s experience or practical skills.
● Claims 8 is rejected under 35 U.S.C. 103 as being unpatentable over Dodson 2020/0242973 in view of Krautim 2009/0110140 and in view of Ellingson 7,220,127.
Regarding claim 8, Dodson in view of Krautim teaches the claimed limitations as discussed above per claim 1.
Dodson, as modified above, does not teach, the container comprises a plurality of additional openings distributed on said wall, configured to enable the passage of said guidewire and/or guiding catheter for endovascular surgery.
However, Ellingson teaches a heart model for practicing a medical procedure (col.3, lines 26-34); and wherein the heart model already incorporates a body/wall that comprises a plurality of openings, which a trainee uses to practice one or more medical procedures—such as: lead insertion, catheter insertion and/or manipulation, etc. (see col.4 lines 24-41).
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 Dodson in view of Ellingson; for example, by creating one or more openings on the body of the heart model; so that the user would be able to practice one or more additional medical procedures that require accessing one or more internal parts of the heart from different locations on the body of the heart; and such implementation further expands the practical skills that the user is acquiring.
Conclusion
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 from 7:00 AM - 3:00 PM.
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/BRUK A GEBREMICHAEL/Primary Examiner, Art Unit 3715
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