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
Examiner acknowledges Applicant’s request to hold the double patenting rejections in abeyance until a determination of allowability of the claims (see page 11 of Applicant’s remarks filed 05/04/2026). Meanwhile, the rejections have been updated necessitated by the amendments to claims.
Applicant's arguments with respect to the rejection of claims 1, 10 and 18 under 35 U.S.C. 103 in view of prior art Geoffrion (US 6338709 B1) and Huelman (US 20160220314 A1) in Applicant’s responses filed 05/04/2025 have been fully considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
That is, Applicant argues on pages 6-9 that prior art Geoffrion (US 6338709 B1) fails to teach one or more markers that are discrete structures separate from the insertion mechanism (see last paragraph of page 6 on Applicant’s remarks). Applicant further asserts that prior art Huelman (US 20160220314 A1) also fails to teach one or more markers that are discrete structures separate from the insertion mechanism (second paragraph on page 8). Applicant makes similar arguments on pages 9-11 with respect to the rejections claim 11 in view of Geoffrion (US 6338709 B1), Huelman (US 20160220314 A1), and Spence (US 20050119734 A1); rejection of claim 12 in view of Geoffrion (US 6338709 B1), Huelman (US 20160220314 A1), and Vrba (US 20190069949 A1); and the rejections of claim 14 and 15 in view of Geoffrion (US 6338709 B1), Huelman (US 20160220314 A1), and De Vries (US 20160166328 A1).
Consequently, newly found prior art, Mawad et al., US 20050165379 A1, which discloses a catheter for providing an embolic material at a desired location comprising a flexible tubular member having a proximal end and a distal end, the tubular member including at least one ring of expansible material affixed to its outer surface less than 25 mm from the distal end. The ring preferably comprises a material that expands in volume when in contact with a liquid, such as a hydrogel or hydrogel foam, or in response to an application of heat. Mawad further discloses in [0021] that when the desired amount of embolic material has been injected and it is desired to remove catheter 10 from the vessel, the catheter is pulled back from the vessel and the expansile ring 42 is detached from tip 40. The detachable expansile tip 42 remains in the feeding vessel held in place by the embolic material which would have refluxed around it. This teaching reads on the limitation “one or more markers that are discrete structures separate from the insertion mechanism”, Mawad in view of Huelman teaches all the limitations of claim 1, 10, and 18, therefore, the rejections are sustained.
Claim Interpretation
Claim 1 recites “the expanded annular state defining a hollow center in an axial direction” and claim 4 which depends from claim 1 recites “wherein the one or more markers include a hollow center”. For purposes of the examination, the recitation of “defining a hollow center” in claim 1 is being attributed to a function of an expanded state of the one or more markers while the recitation of “hollow center” in claim 4 is being interpreted structural features of the one or more markers.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 4-10, 13, 16, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Mawad et al., US 20050165379 A1 in view of Huelman, et al, US 20160220314 A1.
Regarding claim 1, Mawad teaches a device ([0009] discloses a system and method for providing an embolic material to arteriovenous malformations (AVMs) without allowing undesired backflow or leakage of the embolic material past the catheter tip. The present system includes a microcatheter that is provided with a plug of expansile material adjacent to its tip) comprising:
one or more markers (the at least one annular ring 42 of reproduced fig. 4 below and [0015], [0019] calling for additional rings), expandable from a stored state to an expanded annular state, the expanded annular state defining a hollow center in an axial direction ([0019] discloses that the ring surrounds the outer surface of the distal segment 14 of the catheter, meaning the ring 42 includes a hollow center that receives the catheter in both the initial shape and expanded state) and when in the expanded annular state, the one or more markers defining an outer surface sized and shaped for contact with a lumen in an organ ([0017] Ring 42 is preferably sized such that its outer diameter prior to expansion is smaller than the diameter of the vessel at the point where occlusion is desired. This will ensure that the tip 40 of catheter 10 can be positioned at the desired point without becoming stuck in the vessel. Ring 42 is preferably constructed of material that is capable of swelling from its initial size to an expanded size that is large enough to occlude the vessel in which it is placed, but without causing damage to the vessel. Thus, the material from which ring 42 is constructed is preferably selected to provide an expansion ratio that corresponds to the starting and expanded sizes of ring 42. [0020] also discloses that, referring to fig. 4, the present catheter is shown with ring 42 expanded inside a vessel and a mass of embolic material being injected from catheter tip 40 into an AVM or a tumor (vessel and AVM shown in phantom)); and
wherein the one or more markers are configured to be deployed from an insertion mechanism (distal body segment 14 of catheter 10, where [0015] states that the distal end 40 of distal body segment 14 includes at least one annular ring 42 on its outer surface with [0018] also indicating that it is preferred that ring 42 expand sufficiently slowly to allow the physician to position the catheter tip at the desired location before the vessel becomes occluded. On the other hand, if the catheter tip is positioned at the desired location, the physician can simply wait for the prescribed expansion period before continuing the procedure. Meaning the distal body segment 14 serves as the insertion mechanism from which the ring 42 is launched into place within the blood vessel) into the lumen in the organ as one or more discrete structures separate from the insertion mechanism ([0021] When the desired amount of embolic material has been injected and it is desired to remove catheter 10 from the vessel, the catheter is pulled back from the vessel and the expansile ring 42 is detached from tip 40. The detachable expansile tip 42 remains in the feeding vessel held in place by the embolic material which would have refluxed around it).
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Mawad fails to teach one or more tissue, respectively included in or connected to a corresponding one or more markers; and wherein at least one of the one or more markers or the one or more tissue tags includes or is made of the magnetized material and has a magnetic orientation.
However, Huelman teaches a surgical guidance system (see [0031] a surgical guidance system 10 used in a surgical procedure on a patient 12), including hollow disc-shaped magnets 76 of fig. 8 of an implantable device 20 of fig. 8, for guiding a surgical instrument 22 to the region of interest (see paragraph 32), one or more tissue, respectively included in or connected to a corresponding one or more markers (the tags 42 of figs. 5, 7, and 8 are magnets, with [0036] stating that “The implantable device 20 may include a body 40 and a plurality of magnets 42 (see FIG. 3) that emit a magnetic field which surrounds the body 40. The strength of the magnetic field generally decreases as one moves away from the implantable device 20. The plurality of magnets 42 may function as a beacon that marks the location of the bodily lumen to which the implantable device 20 is attached. The plurality of magnets 42 may be embedded in the body 40 of the implantable device 20 as seen in FIG. 3.”); and wherein at least one of the one or more markers or the one or more tissue tags includes or is made of the magnetized material and has a magnetic orientation (figs. 7-8 demonstrate the poles of the magnets. Also see [0052]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Mawad, to include one or more tissue, respectively included in or connected to a corresponding one or more markers; and wherein at least one of the one or more markers or the one or more tissue tags includes or is made of the magnetized material and has a magnetic orientation, as taught by Huelman, to improve a more accurate guiding of the radiation catheter to the site of interest without causing any injury to healthy tissue (see [0012] of Huelman), with a reasonable expectation of success, because Mawad also introduces improved systems and methods for delivering therapy to a desired location ([0002], [0008]).
Regarding claim 2, Mawad in view of Huelman teaches all the limitations of claim 1.
Mawad further teaches wherein the lumen in the organ is a natural orifice and entry of the one or more markers is through the natural orifice ([0013] FIG. 4 is an illustration of the catheter of FIG. 1 emplaced in a vessel and injecting an embolic material into an AVM, where the vessel is a blood vessel according to [0001]).
Regarding claim 4, Mawad in view of Huelman teaches all the limitations of claim 1.
Mawad further teaches wherein the expandable rounded members include a hollow center ([0019] discloses that the ring surrounds the outer surface of the distal segment 14 of the catheter, meaning the ring 42 includes a hollow center that receives the catheter in both the initial shape and expanded state).
Regarding claim 5, Mawad in view of Huelman teaches all the limitations of claim 1.
Mawad further teaches wherein some of the one or more markers (the at least one annular ring 42 of reproduced fig. 4 above and [0015], [0019] calling for additional rings) include one or more solid markers (annular ring 42 of reproduced fig. 4 above) that are deployed into the lumen ([0018] discloses that it is preferred that ring 42 expand sufficiently slowly to allow the physician to position the catheter tip at the desired location before the vessel becomes occluded. On the other hand, if the catheter tip is positioned at the desired location, the physician can simply wait for the prescribed expansion period before continuing the procedure).
Regarding claim 6, Mawad in view of Huelman teaches all the limitations of claim 5.
Mawad further teaches wherein the one or more solid markers comprise a predefined size ([0017] Ring 42 is preferably sized such that its outer diameter prior to expansion is smaller than the diameter of the vessel at the point where occlusion is desired. Ring 42 is preferably constructed of material that is capable of swelling from its initial size to an expanded size that is large enough to occlude the vessel in which it is placed, but without causing damage to the vessel. Thus, the material from which ring 42 is constructed is preferably selected to provide an expansion ratio that corresponds to the starting and expanded sizes of ring 42).
Regarding claim 7, Mawad in view of Huelman teaches all the limitations of claim 5.
Mawad further teaches wherein the one or more solid markers comprise a predefined shape ([0015] states that “Referring now particularly to FIG. 3, in a preferred embodiment of the invention the distal end 40 of distal body segment 14 includes at least one annular ring 42 on its outer surface. Ring 42 is preferably constructed of an expansile or expandable material”).
Regarding claim 8, Mawad in view of Huelman teaches all the limitations of claim 5.
Mawad further teaches wherein the one or more solid markers comprise a predefined size ([0017] Ring 42 is preferably sized such that its outer diameter prior to expansion is smaller than the diameter of the vessel at the point where occlusion is desired. Ring 42 is preferably constructed of material that is capable of swelling from its initial size to an expanded size that is large enough to occlude the vessel in which it is placed, but without causing damage to the vessel. Thus, the material from which ring 42 is constructed is preferably selected to provide an expansion ratio that corresponds to the starting and expanded sizes of ring 42) and a predefined shape ([0015] states that “Referring now particularly to FIG. 3, in a preferred embodiment of the invention the distal end 40 of distal body segment 14 includes at least one annular ring 42 on its outer surface. Ring 42 is preferably constructed of an expansile or expandable material”).
Regarding claim 9, Mawad in view of Huelman teaches all the limitations of claim 5.
Mawad further teaches the insertion mechanism for deploying the one or more markers (distal body segment 14 of catheter 10, where [0015] states that the distal end 40 of distal body segment 14 includes at least one annular ring 42 on its outer surface with [0018] also indicating that it is preferred that ring 42 expand sufficiently slowly to allow the physician to position the catheter tip at the desired location before the vessel becomes occluded. On the other hand, if the catheter tip is positioned at the desired location, the physician can simply wait for the prescribed expansion period before continuing the procedure. Meaning the distal body segment 14 serves as the insertion mechanism from which the ring 42 is launched into place within the blood vessel).
Regarding claim 10, Mawad teaches a surgical system ([0009] discloses a system and method for providing an embolic material to arteriovenous malformations (AVMs) without allowing undesired backflow or leakage of the embolic material past the catheter tip. The present system includes a microcatheter that is provided with a plug of expansile material adjacent to its tip) comprising:
one or more tissue effecting elements including a tip (microcatheter of [0009] including a catheter tip);
one or more device tags (radiopaque markers 32 of [0014], which states a radiopaque marker 32 is preferably provided near the shoulder, at the transition, preferably recessed within lumen 34 of the proximal body segment 12 and 39 of [0019] which states a plurality of radiopaque markers 39 are included at predetermined distances from tip 40. Markers 39 facilitate placement of catheter tip 40, and can comprise any suitable material such as are known in the art); and
an insertion mechanism (distal body segment 14 of fig. 1, reproduced fig. 3 below and [0015]) configured to deploy a device into a lumen of an organ at a predetermined location relative to a target tissue (distal body segment 14 of catheter 10, where [0015] states that the distal end 40 of distal body segment 14 includes at least one annular ring 42 on its outer surface with [0018] also indicating that it is preferred that ring 42 expand sufficiently slowly to allow the physician to position the catheter tip at the desired location before the vessel becomes occluded. On the other hand, if the catheter tip is positioned at the desired location, the physician can simply wait for the prescribed expansion period before continuing the procedure. Meaning the distal body segment 14 serves as the insertion mechanism from which the ring 42 is launched into place within the blood vessel) as one or more discrete structures separate from the insertion mechanism([0021] When the desired amount of embolic material has been injected and it is desired to remove catheter 10 from the vessel, the catheter is pulled back from the vessel and the expansile ring 42 is detached from tip 40. The detachable expansile tip 42 remains in the feeding vessel held in place by the embolic material which would have refluxed around it),
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the device including: one or more markers (the at least one annular ring 42 of reproduced fig. 4 above and [0015], [0019] calling for additional rings), expandable from a stored state to an expanded annular state, the expanded annular state defining a hollow center in an axial direction ([0019] discloses that the ring surrounds the outer surface of the distal segment 14 of the catheter, meaning the ring 42 includes a hollow center that receives the catheter in both the initial shape and expanded state) and when in the expanded annular state, the one or more markers defining an outer surface sized and shaped for contact with a lumen in an organ ([0017] Ring 42 is preferably sized such that its outer diameter prior to expansion is smaller than the diameter of the vessel at the point where occlusion is desired. This will ensure that the tip 40 of catheter 10 can be positioned at the desired point without becoming stuck in the vessel. Ring 42 is preferably constructed of material that is capable of swelling from its initial size to an expanded size that is large enough to occlude the vessel in which it is placed, but without causing damage to the vessel. Thus, the material from which ring 42 is constructed is preferably selected to provide an expansion ratio that corresponds to the starting and expanded sizes of ring 42. [0020] also discloses that, referring to fig. 4, the present catheter is shown with ring 42 expanded inside a vessel and a mass of embolic material being injected from catheter tip 40 into an AVM or a tumor (vessel and AVM shown in phantom)); and
Mawad fails to teach that the one or more device tags (radiopaque markers 32 of [0014] and 39 of [0019]), having a magnetic orientation providing an information of positional relationship with the tip of the one or more tissue effecting elements; and one or more tissue tags, respectively included in or connected to a corresponding one or more markers; and wherein at least one of the one or more markers or the one or more tissue tags includes or is made of the magnetized material and has a magnetic orientation.
However, within the same field of endeavor, Huelman teaches a surgical guidance system (see [0031] a surgical guidance system 10 used in a surgical procedure on a patient 12), including hollow disc-shaped magnets 42 of fig. 5 of an implantable device 20, for guiding a surgical instrument 22 to the region of interest ([0032] stating Generally, during a surgical procedure, the implantable device 20 is introduced into the patient 12 and attached to an anatomical structure (e.g., tissue, organ, vessel, etc.)) including one or more device tags (proximity sensor 24 of reproduced figs. 11 and 12 below) having a magnetic orientation providing an information of positional relationship with the tip of the one or more tissue effecting elements ([0031] discloses that “ In general, the surgical guidance system 10 includes an implantable device 20 configured to emit a detectable field having an intensity (e.g., a strength) that varies with distance, a surgical instrument 22, a proximity sensor 24 attached to the surgical instrument 22 and configured to detect the intensity of the detectable field”. [0032] further emphasizes that As the surgical instrument 22 approaches the non-target anatomical structure, the proximity sensor 24 detects changes in the intensity of the detectable field emitted by the implantable device 20. If the intensity of the detectable field detected by the proximity sensor 24 is equal to or greater than a predetermined intensity level, the control unit 26 may determine that the surgical instrument 22 is within a predetermined distance of the implantable device 20, and subsequently control the notification unit 28 to notify (e.g., alert, warn, etc.) the surgeon of the proximity of the surgical instrument 22 to the non-target anatomical structure.);
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one or more tissue tags, respectively included in or connected to a corresponding one or more markers (the magnets 42 of figs. 5-7 are magnets, with [0036] stating that “The implantable device 20 may include a body 40 and a plurality of magnets 42 (see FIG. 3) that emit a magnetic field which surrounds the body 40. The strength of the magnetic field generally decreases as one moves away from the implantable device 20. The plurality of magnets 42 may function as a beacon that marks the location of the bodily lumen to which the implantable device 20 is attached. The plurality of magnets 42 may be embedded in the body 40 of the implantable device 20 as seen in FIG. 3”. The magnets 42 comprise the one or more tissue tags); and wherein at least one of the one or more markers or the one or more tissue tags includes or is made of the magnetized material and has a magnetic orientation (the magnets 42 (the one or more tissue tags) (0031]-[0032] are taught in [0051]-[0052] as having respective magnetic fields 70 oriented in different directions).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Mawad, to include the one or more device tags (radiopaque markers 32 of [0014] and 39 of [0019]), having a magnetic orientation providing an information of positional relationship with the tip of the one or more tissue effecting elements; and one or more tissue tags, respectively included in or connected to a corresponding one or more markers; and wherein at least one of the one or more markers or the one or more tissue tags includes or is made of the magnetized material and has a magnetic orientation, as taught by Huelman, to improve a more accurate guiding of the radiation catheter to the site of interest without causing any injury to healthy tissue (see [0012] of Huelman), with a reasonable expectation of success, because Mawad also introduces improved systems and methods for delivering therapy to a desired location ([0002], [0008]).
Regarding claim 13, Mawad in view of Huelman teaches all the limitations of claim 10 above.
Mawad fails to teach wherein the tissue effecting element is a blade or a needle.
However, Huelman further teaches wherein the tissue effecting element is a blade or a needle ([0057] discloses that As an addition to, or as an alternative to the grasping members 200, 202, the surgical tool attached to the distal end 212 of the surgical instrument 22 may include any one of, or any combination of: scissors, calipers, forceps, an occluder, a clamp, a retractor, a distractor, a scalpel, a lancet, a drill, a drill bit, rasps, trocars, a harmonic scalpel, rongeurs, a dilator, a specula, a suction tube, a stapler, a needle, a probe, an endoscope, a mechanical cuter, an ultrasonic cutter, a laser cutter, and/or any other suitable surgical tool).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Mawad, wherein the tissue effecting element is a blade or a needle, as taught by Huelman to improve a more accurate guiding of the radiation catheter to the site of interest without causing any injury to healthy tissue (see [0012] of Huelman), with a reasonable expectation of success, because Mawad also introduces improved systems and methods for delivering therapy to a desired location ([0002], [0008]).
Regarding claim 16, Mawad in view of Huelman teaches all the limitations of claim 10 above.
Mawad fails to teach a display system configured to indicate a proximity of the tip of the one or more tissue effecting elements to the one or more markers.
However, Huelman further teaches a display system (notification unit 28 (which is a touchscreen display according to [0065])) configured to indicate a proximity of the tip of the one or more tissue effecting elements to the one or more markers (see [0065] for the notification based on the proximity information garnered in [0032], with [0065] indicating that the notification generated by the notification unit 28 may take the form of a vibration generated in the handle unit 205 which can be felt by the operator of the surgical instrument, a flashing light, a colored light such as red light, an audible alarm, a graphic displayed on a screen, text displayed on a screen, or any combination thereof, and/or any other form of communication).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Mawad, a display system configured to indicate a proximity of the tip of the one or more tissue effecting elements to the one or more markers, as taught by Huelman to provide a more accurate guiding of the radiation catheter to the site of interest without causing any injury to healthy tissue (see [0012] of Huelman), with a reasonable expectation of success, because Mawad also introduces improved systems and methods for delivering therapy to a desired location ([0002], [0008]).
Regarding claim 18, Mawad teaches a device ([0009] discloses a system and method for providing an embolic material to arteriovenous malformations (AVMs) without allowing undesired backflow or leakage of the embolic material past the catheter tip. The present system includes a microcatheter that is provided with a plug of expansile material adjacent to its tip) comprising:
an insertion mechanism (distal body segment 14 of catheter 10, where [0015] states that the distal end 40 of distal body segment 14 includes at least one annular ring 42 on its outer surface with [0018] also indicating that it is preferred that ring 42 expand sufficiently slowly to allow the physician to position the catheter tip at the desired location before the vessel becomes occluded. On the other hand, if the catheter tip is positioned at the desired location, the physician can simply wait for the prescribed expansion period before continuing the procedure. Meaning the distal body segment 14 serves as the insertion mechanism from which the ring 42 is launched into place within the blood vessel);
a plurality of markers (the at least one annular ring 42 of reproduced fig. 4 above and [0015], [0019] calling for additional rings), expandable from a stored state to an expanded annular state, the expanded annular state defining a hollow center in an axial direction ([0019] discloses that the ring surrounds the outer surface of the distal segment 14 of the catheter, meaning the ring 42 includes a hollow center that receives the catheter in both the initial shape and expanded state) and when in the expanded annular state, each of the plurality of markers defining an outer surface sized and shaped for contact with a lumen in an organ ([0017] Ring 42 is preferably sized such that its outer diameter prior to expansion is smaller than the diameter of the vessel at the point where occlusion is desired. This will ensure that the tip 40 of catheter 10 can be positioned at the desired point without becoming stuck in the vessel. Ring 42 is preferably constructed of material that is capable of swelling from its initial size to an expanded size that is large enough to occlude the vessel in which it is placed, but without causing damage to the vessel. Thus, the material from which ring 42 is constructed is preferably selected to provide an expansion ratio that corresponds to the starting and expanded sizes of ring 42. [0020] also discloses that, referring to fig. 4, the present catheter is shown with ring 42 expanded inside a vessel and a mass of embolic material being injected from catheter tip 40 into an AVM or a tumor (vessel and AVM shown in phantom));
wherein the one or more markers are configured to be deployed from an insertion mechanism (distal body segment 14 of catheter 10, where [0015] states that the distal end 40 of distal body segment 14 includes at least one annular ring 42 on its outer surface with [0018] also indicating that it is preferred that ring 42 expand sufficiently slowly to allow the physician to position the catheter tip at the desired location before the vessel becomes occluded. On the other hand, if the catheter tip is positioned at the desired location, the physician can simply wait for the prescribed expansion period before continuing the procedure. Meaning the distal body segment 14 serves as the insertion mechanism from which the ring 42 is launched into place within the blood vessel) into the lumen in the organ as one or more discrete structures separate from the insertion mechanism ([0021] When the desired amount of embolic material has been injected and it is desired to remove catheter 10 from the vessel, the catheter is pulled back from the vessel and the expansile ring 42 is detached from tip 40. The detachable expansile tip 42 remains in the feeding vessel held in place by the embolic material which would have refluxed around it).
Mawad fails to teach one or more tissue, respectively included in or connected to a corresponding one or more markers; and wherein at least one of the one or more markers or the one or more tissue tags includes or is made of the magnetized material and has a magnetic orientation.
However, within the same field of endeavor, Huelman teaches a surgical guidance system (see [0031]), including hollow disc-shaped magnets 76 of fig. 8 of an implantable device 20 of fig. 8, for guiding a surgical instrument 22 to the region of interest (see paragraph 32), one or more tissue, respectively included in or connected to a corresponding one or more markers (the tags 42 of figs. 5, 7, and 8 are magnets, with [0036] stating that “The implantable device 20 may include a body 40 and a plurality of magnets 42 (see FIG. 3) that emit a magnetic field which surrounds the body 40. The strength of the magnetic field generally decreases as one moves away from the implantable device 20. The plurality of magnets 42 may function as a beacon that marks the location of the bodily lumen to which the implantable device 20 is attached. The plurality of magnets 42 may be embedded in the body 40 of the implantable device 20 as seen in FIG. 3.”); and wherein at least one of the one or more markers or the one or more tissue tags includes or is made of the magnetized material and has a magnetic orientation (figs. 7-8 demonstrate the poles of the magnets. Also see [0052]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Mawad, to include one or more tissue, respectively included in or connected to a corresponding one or more markers; and wherein at least one of the one or more markers or the one or more tissue tags includes or is made of the magnetized material and has a magnetic orientation, as taught by Huelman, to improve a more accurate guiding of the radiation catheter to the site of interest without causing any injury to healthy tissue (see [0012] of Huelman), with a reasonable expectation of success, because Mawad also introduces improved systems and methods for delivering therapy to a desired location ([0002], [0008]).
Regarding claim 19, Mawad in view of Huelman teaches all the limitations of claim 18 above.
Mawad further teaches wherein the lumen in the organ is a natural orifice and entry of the one or more markers is through the natural orifice ([0013] FIG. 4 is an illustration of the catheter of FIG. 1 emplaced in a vessel and injecting an embolic material into an AVM, where the vessel is a blood vessel according to [0001]).
Claims 3, 17 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Geoffrion, et al., US 6338709 B1 in view of Huelman, et al, US 20160220314 A1.
Regarding claim 3, Mawad in view of Huelman teaches all the limitations of claim 1.
Mawad in view of Huelman fails to teach wherein all or a portion of the expandable rounded members are made of nitinol.
However, within the same field of endeavor, Geoffrion teaches a radiation delivering catheter that is positioned away from the walls of a vessel to be treated, e.g. at a stenosis site, so that the radiation flux impacting the walls is more uniform. In one embodiment, one or more balloons are used, and in another, one or more expandable structures (see abstract). Geoffrion further teaches wherein all or a portion of the expandable rounded members are made of nitinol (braids, 1010 and 1000 are made of nitinol according to col. 16, lines 61-65, which states that The braids of the embodiments disclosed herein may be stainless steel 304 or 400, superelastic or heat activated Nitinol, or a polymer base, such as polyethylene or polypropylene. They may be constructed, for example, by using standard equipment such as a braider).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Mawad, as modified by Huelman, wherein all or a portion of the expandable rounded members are made of nitinol, as taught by Geoffrion, as such modification would permit accurate placement and delivery of the required therapy to the region of interest (col. 2, lines 41-47), with a reasonable expectation of success, as Mawad also introduces improved systems and methods for delivering therapy to a desired location ([0002], [0008]).
Regarding claim 17, Mawad in view of Huelman teaches all the limitations of claim 10 above.
Mawad further teaches wherein the one or more markers include two markers ([0019] states that furthermore, in some instances it may be desired to provide a second or further ring of expansible material).
Mawad fails to teach that the one or more device tags includes a device tag located between the two markers.
However, Huelman further teaches one or more device tags includes a device tag located between the two markers (a proximity sensor 24 attached to a distal portion of a surgical instrument 22 (see figs. 11 and 12). The recitation of “located between the two markers” is considered a statement of intended use and fails to impart further structural elements to the claim. The device of Mawad in view of Huelman comprises the proximity sensor 24 that determines if the distal end of the surgical instrument is within a predetermined distance of the implantable device, that comprises the magnets. So that, when [0013] of Huelman discloses detectable field, it is referring to the magnetic field induced by the magnets 42 (device tag) which is sensed by the proximity sensor 24 in the vicinity of the magnets 42, which evidences the proximity sensor 24 being configured to be located between the two markers. MPEP 2114(II)).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Mawad, one or more device tags includes a device tag located between the two markers, as taught by Huelman to provide a more accurate guiding of the radiation catheter to the site of interest without causing any injury to healthy tissue (see [0012] of Huelman), with a reasonable expectation of success, because Mawad also introduces improved systems and methods for delivering therapy to a desired location ([0002], [0008]).
Mawad in view of Huelman fails to teach that the two markers are adapted to bracket a surgical site.
However, within the same field of endeavor, Geoffrion teaches a radiation delivering catheter that is positioned away from the walls of a vessel to be treated, e.g. at a stenosis site, so that the radiation flux impacting the walls is more uniform. In one embodiment, one or more balloons are used, and in another, one or more expandable structures (see abstract). Geoffrion further teaches wherein the markers comprise two markers that bracket a surgical site (reproduced fig. 15 below depicts markers (braids 1010 and 1000), bracketing a stenosis site 1005. Col. 15, lines 51-56 indicate that a distal braid 1000 and a proximal braid 1010 are preferably positioned on either side of a stenosis site 1005. When deployed as in FIG. 15, the braids 1000 and 1010 secure a radiation catheter 1020 and its radiation source 1022, so that the stenosis site 1005 can be uniformly irradiated).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Mawad, as modified by Huelman, wherein the markers comprise two markers that bracket a surgical site, as taught by Geoffrion, as such modification would permit accurate placement and delivery of the required therapy to the region of interest (col. 2, lines 41-47), with a reasonable expectation of success, as Mawad also introduces improved systems and methods for delivering therapy to a desired location ([0002], [0008]).
Regarding claim 20, Mawad in view of Huelman teaches all the limitations of claim 18.
Mawad in view of Huelman fails to teach wherein all or a portion of the expandable rounded members are made of nitinol.
However, within the same field of endeavor, Geoffrion teaches a radiation delivering catheter that is positioned away from the walls of a vessel to be treated, e.g. at a stenosis site, so that the radiation flux impacting the walls is more uniform. In one embodiment, one or more balloons are used, and in another, one or more expandable structures (see abstract). Geoffrion further teaches wherein all or a portion of the expandable rounded members are made of nitinol (braids, 1010 and 1000 are made of nitinol according to col. 16, lines 61-65, which states that The braids of the embodiments disclosed herein may be stainless steel 304 or 400, superelastic or heat activated Nitinol, or a polymer base, such as polyethylene or polypropylene. They may be constructed, for example, by using standard equipment such as a braider).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Mawad, as modified by Huelman, wherein all or a portion of the expandable rounded members are made of nitinol, as taught by Geoffrion, as such modification would permit accurate placement and delivery of the required therapy to the region of interest (col. 2, lines 41-47), with a reasonable expectation of success, as Mawad also introduces improved systems and methods for delivering therapy to a desired location ([0002], [0008]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Mawad et al., US 20050165379 A1 in view of Huelman, et al, US 20160220314, as applied to claim 10 above, and further in view of Spence, US 20050119734.
Regarding claim 11, Mawad in view of Huelman teaches all the limitations of claim 10 above.
Mawad in view of Huelman fails to teach wherein the device has a magnetic orientation that repels at least one of the one or more device tags.
However, within the same field of endeavor, Spence teaches a system for applying fasteners to a region of interest for surgical procedure ([0026]). The paragraph further discloses that one guide element of the invention comprises first and second spaced apart magnets on the distal support portion of a catheter. Repelling poles of the magnets face each other to create a circumferential virtual pole emanating around the gap formed between the spaced apart magnets. Securing the first and second guide elements together can further comprise magnetically attracting the first and second guide elements together and hence teaching “wherein the device has a magnetic orientation that repels at least one of the one or more device tags”.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Mawad, as modified by Huelman, wherein the device has a magnetic orientation that repels at least one of the one or more device tags, as taught by Spence, to produce forces of repulsion between the magnet and the proximity sensor for accurate positioning of the catheter ([0023] of Spence), with a reasonable expectation of success, as Mawad also introduces improved systems and methods for delivering therapy to a desired location ([0002], [0008]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Mawad et al., US 20050165379 A1 in view of Huelman, et al, US 20160220314, as applied to claim 10 above and further in view of Vrba, et al., US 20190069949 A1 and Weber, et al., US 20040010304 A1.
Regarding claim 12, Mawad in view of Huelman teaches all the limitations of claim 10 above.
Mawad in view of Huelman fails to teach wherein the one or more device tags present a magnetic field of common polarity as the one or more tissue tags of the device so that the one or more device tags provide an increase in tactile resistance to the tip of the tissue effecting element moving towards the one or more tissue tags, the target tissue and the one or more tissue tags are displaced as the one or more device tags are moved towards the target tissue and the one or more tissue tags.
However, within the same field of endeavor, Vrba teaches systems, devices and methods for modulating targeted nerve fibers (e.g., hepatic neuromodulation) or other tissue are provided. The systems may be configured to access tortuous anatomy of or adjacent hepatic vasculature. The systems may be configured to target nerves surrounding (e.g., within adventitia of or within perivascular space of) an artery or other blood vessel, such as the common hepatic artery (see abstract), the system, devices, and methods further including a temporary frame or scaffold 11300 configured to provide vessel stabilization and to provide landmarks for positioning treatment elements (e.g., ablation electrodes) of a neuromodulation device or system (see [0656]), wherein the one or more device tags present a magnetic field of common polarity as the one or more tissue tags of the device so that the one or more device tags provide an increase in tactile resistance to the tip of the tissue effecting element moving towards the one or more tissue tags ([0659] states that “the frame 11300 provides for mechanical orientation and positioning of treatment elements (e.g., electrodes). For example, interaction between the frame 11300 and an electrode assembly may provide tactile feedback or direct positioning of the electrode(s) with respect to the frame 11300. When used in conjunction with electrode catheters, the frame 11300 may also provide for electrical position sensing to aid electrode placement. Electrical position sensing may be accomplished by providing a sensing element on the electrode shaft that detects proximity to a corresponding element on the frame 11300 or vice-versa. The sensing element may detect proximity using continuity, resistance, conductivity, magnetoresistance (e.g., GMR), Hall Effect, capacitance, magnetism, light, reflectance, absorbance, refraction, diffraction, sound, acoustic reflection, and/or the like.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Geoffrion, as modified by Huelman, wherein the one or more device tags present a magnetic field of common polarity as the one or more tissue tags of the device so that the one or more device tags provide an increase in tactile resistance to the tip of the tissue effecting element moving towards the one or more tissue tags, as taught by Vrba, since the frame 11300 advantageously stabilizes the vessel wall in the region of a target ablation site by placing the vessel wall under slight tension, thereby limiting or reducing the deformation of the vessel wall by the contact forces imposed by the electrode(s) (paragraph 659), with a reasonable expectation of success, as Mawad also introduces improved systems and methods for delivering therapy to a desired location ([0002], [0008]).
Mawad in view of Huelman and Vrba fails to teach the target tissue and the one or more tissue tags are displaced as the one or more device tags are moved towards the target tissue and the one or more tissue tags.
However, within the same field of endeavor, Weber teaches compressing a prosthesis, e.g., a therapeutic agent-carrying stent or stent-graft, to a catheter without contacting an outer surface of the prosthesis, e.g., by electromagnetically compressing the prosthesis (abstract), including attaching marker bands to an inner shaft of a balloon catheter (i.e., underneath a balloon), after the balloon has been attached (e.g., welded) to the inner shaft and an outer shaft according to [0056]. [0057] then goes on to disclose steps to move the marker bands axially along the inner shaft underneath the balloon, and indicating that the band(s) can be moved along the inner shaft by positioning the balloon such that the marker band(s) is outside the forming coil, and by pulsing the coil. The magnetic field from the coil can axially displace (e.g., attract or repel) the marker band(s). The marker band(s) can also be axially displaced by using permanent magnets and/or electrostatic forces, and hence teaching that the target tissue and the one or more tissue tags are displaced as the one or more device tags are moved towards the target tissue and the one or more tissue tags.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Mawad, as modified by Huelman and Vrba, wherein the target tissue and the one or more tissue tags are displaced as the one or more device tags are moved towards the target tissue and the one or more tissue tags, as taught by Weber, providing accurate delivery of therapy to a desired region of interest ([0006]), with a reasonable expectation of success, as Mawad also introduces improved systems and methods for delivering therapy to a desired location ([0002], [0008]).
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Mawad et al., US 20050165379 A1 in view of Huelman, et al, US 20160220314, as applied to claim 10 above, and further in view of De Vreis, et al., US 20160166328.
Regarding claim 14, Mawad in view of Huelman teaches all the limitations of claim 10 above.
Mawad in view of Huelman fails to teach an alarm system configured to provide a signal when the tip of the one or more tissue effecting elements is located within a predetermined distance from each of the one or more markers.
However, within the same field of endeavor, De Vreis teaches a brachytherapy system, and brachytherapy position and verification system (see abstract) comprising a verification element ([0012] stating that a verification element coupled to a distal region. The verification element may be configured to detect the presence of a reference marker associated with the conduit and transmit a signal indicative of the position of the reference marker relative to the verification element), where the brachytherapy system includes an applicator 4 ([0049]) with an alarm system configured to provide a signal when the tip of the one or more tissue effecting elements is located within a predetermined distance from each of the one or more markers ([0068]-[0071] note that If the position verification system detects a mismatch between the positioning detected by the verification element and the expected positioning location, the processor may send a signal indicating to the healthcare provider that something is wrong and also that the position verification system may also be able to detect a deviation between the expected conduit identity and the actual identity of the conduit in which the verification element is deployed. If a deviation is detected, the system may send a signal indicating to the healthcare provider that something is wrong).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Mawad, as modified by Huelman, with an alarm system configured to provide a signal when the tip of the one or more tissue effecting elements is located within a predetermined distance from each of the one or more markers, as taught by De Vreis, so that an accurate radiotherapy source positioning is achieved, ([0010] of De Vreis), while also ensuring safety during treatment ([0070] of De Vreis), with a reasonable expectation of success, as Mawad also introduces improved systems and methods for delivering therapy to a desired location ([0002], [0008]).
Regarding claim 15 Mawad in view of Huelman teaches all the limitations of claim 10 above.
Mawad in view of Huelman fails to teach means for removing power supplied to the tip when the tip of the one or more tissue effecting elements is located within a predetermined distance from each of the one or more markers.
However, De Vreis further teaches a brachytherapy system, and brachytherapy position and verification system (see abstract) comprising a verification element ([0012] stating that a verification element coupled to a distal region. The verification element may be configured to detect the presence of a reference marker associated with the conduit and transmit a signal indicative of the position of the reference marker relative to the verification element), where the brachytherapy system includes an applicator 4 with one or more device tags (reference markers 5 of fig. 2) having a spatial relationship and magnetic orientation with the tip of the one or more tissue effecting elements ([0044]-[0045]); and means ([0058] discloses a power supply from the control system 14 of the verification system) for removing power supplied to the tip when the tip of the one or more tissue effecting elements is located within a predetermined distance from each of the one or more markers ([0069] notes that “when a deviation is detected, the system may not make any changes or generate any signal, for example, if the deviation is within a certain, predetermined threshold of tolerance” and paragraph 70 states that “If a deviation is detected that is outside a threshold level of tolerance, then the system may prevent or halt the delivery of radiotherapy treatment until after the discrepancy is corrected”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Mawad, as modified by Huelman, with means for removing power supplied to the tip when the tip of the one or more tissue effecting elements is located within a predetermined distance from each of the one or more markers, as taught by De Vreis, so that an accurate radiotherapy source positioning is achieved, ([0010] of De Vreis), while also ensuring safety during treatment ([0070] of De Vreis), with a reasonable expectation of success, as Mawad also introduces improved systems and methods for delivering therapy to a desired location ([0002], [0008]).
Double Patenting
The nonstatutory provisional double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory provisional double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 3-18, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11,986,358 B2 in view of Mawad, M.E., US 20050165379 A1. Although the claims at issue are not identical, they are not patentably distinct from each other because the limitations recited in the claims mentioned above of the instant application are also recited in the claims mentioned above of the copending application.
Instant Application
U.S. Patent No. 11,986,358 B2
1. (Currently Amended) A device comprising:
one or more markers, expandable from a stored state to an expanded annular state, the expanded annular state defining a hollow center in an axial direction and when in the expanded annular state, the one or more markers defining an outer surface sized and shaped for contact with a lumen in an organ; and
one or more tissue tags, respectively included in or connected to a corresponding one or more markers;
wherein the one or more markers are configured to be deployed from an insertion mechanism into the lumen in the organ; and
wherein at least one of the one or more markers or the one or more tissue tags includes or is made of the magnetized material and has a magnetic orientation.
1. A surgical system comprising: a device comprising: plurality of markers, two or more of which are expandable rounded members that are positionable in a same lumen in an organ, the expandable rounded members being expandable from a stored state to an expanded state and when in the expanded state each of the expandable rounded members are configured to expand to move into contact with the lumen in the organ; and
wherein each of the expandable rounded members comprise a tissue tag;
wherein the expandable rounded members are configured to be located within and deployed from the insertion mechanism into the lumen in the organ at a predetermined location relative to the target tissue;
each of the tissue tags being magnetized or comprising a magnet
U.S. Patent No. 11,986,358 B2 fails to disclose that the one or more markers are configured to be deployed as one or more discrete structures separate from the insertion mechanism.
However, within the same field of endeavor, Mawad teaches a system and method for providing an embolic material to arteriovenous malformations (AVMs) without allowing undesired backflow or leakage of the embolic material past the catheter tip. The present system includes a microcatheter that is provided with a plug of expansile material adjacent to its tip according to [0009], the system comprising at least one annular ring 42 of reproduced fig. 4 above and [0015], [0019] calling for additional rings and wherein the one or more markers (the at least one annular ring 42 of reproduced fig. 4 above and [0015], [0019] calling for additional rings) are configured to be deployed as one or more discrete structures ([0015] states that the distal end 40 of distal body segment 14 includes at least one annular ring 42 on its outer surface with [0018] also indicating that it is preferred that ring 42 expand sufficiently slowly to allow the physician to position the catheter tip at the desired location before the vessel becomes occluded. On the other hand, if the catheter tip is positioned at the desired location, the physician can simply wait for the prescribed expansion period before continuing the procedure. Meaning the distal body segment 14 serves as the insertion mechanism from which the ring 42 is launched into place within the blood vessel) separate from the insertion mechanism ([0021] When the desired amount of embolic material has been injected and it is desired to remove catheter 10 from the vessel, the catheter is pulled back from the vessel and the expansile ring 42 is detached from tip 40. The detachable expansile tip 42 remains in the feeding vessel held in place by the embolic material which would have refluxed around it).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure U.S. Patent No. 11,986,358 B2, the one or more markers are configured to be deployed as one or more discrete structures separate from the insertion mechanism, as taught by Mawad, to provide improved systems and methods for delivering therapy to a desired location ([0002], [0008]), with a reasonable expectation of success as U.S. Patent No. 11,986,358 B2 is also concerned with accurate placement of a therapy at a desired location col. 1, lines 41-46.
3. (Currently Amended) The device of claim 1, wherein all or a portion of the one or more markers are made of nitinol
2. The surgical system of claim 1, wherein all or a portion of the expandable rounded members of the plurality of markers are made of nitinol.
4. (Currently Amended) The device of claim 1, wherein the one or more markers include a hollow center.
3. The surgical system of claim 1, wherein the expandable rounded members of the plurality of markers include a hollow center.
5. (Original) The device of claim 1, wherein some of the one or more markers include one or more solid markers that are deployed into the lumen.
6. (Original) The device of claim 5, wherein the one or more solid markers comprise a predefined size.
7. (Original) The device of claim 5, wherein the one or more solid markers comprise a predefined shape.
4. The surgical system of claim 1, wherein some of the markers include one or more solid markers that are configured to be deployed into the lumen, the one or more solid markers comprising at least one of a predefined size or a predefined shape.
9. (Currently Amended) The device of claim 1, further comprising the insertion mechanism for deploying the one or more markers.
1… wherein the expandable rounded members are configured to be located within and deployed from the insertion mechanism into the lumen in the organ at a predetermined location relative to the target tissue;…
10. (Currently Amended) A surgical system comprising:
one or more tissue effecting elements including a tip;
one or more device tags having a magnetic orientation providing an information of positional relationship with the tip of the one or more tissue effecting elements; and
an insertion mechanism configured to deploy a device into a lumen of an organ at a predetermined location relative to a target tissue
the device including: one or more markers, expandable from a stored state to an expanded annular state, the expanded annular state defining a hollow center in an axial direction and when in the expanded annular state, the one or more markers defining an outer surface sized and shaped for contact with the lumen; and
one or more tissue tags, respectively included in or connected to a corresponding one or more markers; wherein at least one of the one or more markers or the one or more tissue tags includes or is made of magnetized material and has a magnetic orientation.
1. A surgical system comprising:
one or more tissue effecting elements including a tip;
one or more device tags connected to the one or more tissue effecting elements, each of the one or more device tags having a spatial relationship and magnetic orientation with the tip of the one or more tissue effecting elements;
an insertion mechanism including a device comprising:
wherein the expandable rounded members are configured to be located within and deployed from the insertion mechanism into the lumen in the organ at a predetermined location relative to the target tissue
one or more markers, some or all of which are expandable rounded members that are expandable from a stored state to an expanded state and when in the expanded state each of the expandable rounded members are configured to expand to move into contact with a lumen in an organ, the lumen defining a longitudinal axis; and
wherein each of the expandable rounded members comprise a tissue tag, each of the tissue tags being magnetized or comprising a magnet;
U.S. Patent No. 11,986,358 B2 fails to disclose that the one or more markers are configured to be deployed as one or more discrete structures separate from the insertion mechanism.
However, within the same field of endeavor, Mawad teaches a system and method for providing an embolic material to arteriovenous malformations (AVMs) without allowing undesired backflow or leakage of the embolic material past the catheter tip. The present system includes a microcatheter that is provided with a plug of expansile material adjacent to its tip according to [0009], the system comprising at least one annular ring 42 of reproduced fig. 4 above and [0015], [0019] calling for additional rings and wherein the one or more markers (the at least one annular ring 42 of reproduced fig. 4 above and [0015], [0019] calling for additional rings) are configured to be deployed as one or more discrete structures ([0015] states that the distal end 40 of distal body segment 14 includes at least one annular ring 42 on its outer surface with [0018] also indicating that it is preferred that ring 42 expand sufficiently slowly to allow the physician to position the catheter tip at the desired location before the vessel becomes occluded. On the other hand, if the catheter tip is positioned at the desired location, the physician can simply wait for the prescribed expansion period before continuing the procedure. Meaning the distal body segment 14 serves as the insertion mechanism from which the ring 42 is launched into place within the blood vessel) separate from the insertion mechanism([0021] When the desired amount of embolic material has been injected and it is desired to remove catheter 10 from the vessel, the catheter is pulled back from the vessel and the expansile ring 42 is detached from tip 40. The detachable expansile tip 42 remains in the feeding vessel held in place by the embolic material which would have refluxed around it).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure U.S. Patent No. 11,986,358 B2, the one or more markers are configured to be deployed as one or more discrete structures separate from the insertion mechanism, as taught by Mawad, to provide improved systems and methods for delivering therapy to a desired location ([0002], [0008]), with a reasonable expectation of success as U.S. Patent No. 11,986,358 B2 is also concerned with accurate placement of a therapy at a desired location col. 1, lines 41-46.
11. (Original) The surgical system of claim 10, wherein the device has a magnetic orientation that repels at least one of the one or more device tags.
5. The surgical system of claim 1, wherein the device has a magnetic orientation that repels the one or more device tags.
12. (Previously Presented) The surgical system of claim 10, wherein the one or more device tags present a magnetic field of common polarity as the one or more tissue tags of the device so that the one or more device tags provide an increase in tactile resistance to the tip of the tissue effecting element moving towards the one or more tissue tags, the target tissue and the one or more tissue tags are displaced as the one or more device tags are moved towards the target tissue and the one or more tissue tags.
1… wherein the one or more device tags present a magnetic field of common polarity respectively with each of the tissue tags of the device so that the one or more device tags provide an increase in tactile resistance to the tip of the one or more tissue effecting elements moving towards the tissue tags, the target tissue and the tissue tags are displaced as the one or more device tags are configured to be moved towards the target tissue and the tissue tags.
13. (Original) The surgical system of claim 10, wherein the one or more tissue effecting elements is a blade or a needle.
6. The surgical system of claim 1, wherein at least one of the one or more tissue effecting elements is a blade or a needle.
14. (Original) The surgical system of claim 10, further comprising an alarm system configured to provide a signal when the tip of the one or more tissue effecting elements is located within a predetermined distance from each of the one or more markers.
15. (Original) The surgical system of claim 10, further comprising means for removing power supplied to the tip when the tip of the one or more tissue effecting elements is located within a predetermined distance from each of the one or more markers.
16. (Original) The surgical system of claim 10, further comprising a display system configured to indicate a proximity of the tip of the one or more tissue effecting elements to the one or more markers.
7. The surgical system of claim 1, further comprising at least one of: a. a display system configured to indicate a proximity of the tip of the one or more tissue effecting elements to the plurality of markers; b. an alarm system configured to provide a signal when the tip of the one or more tissue effecting elements is located within a predetermined distance from each of the plurality of markers; or c. means for removing power supplied to the tip when the tip of the one or more tissue effecting elements is located within a predetermined distance from each of the plurality of markers.
17. (Currently Amended) The surgical system of claim 10, wherein the one or more markers include two markers that are adapted to bracket a surgical site and the one or more device tags includes a device tag located between the two markers.
11. The surgical system of claim 7, wherein the plurality of markers comprise two markers that are adapted to bracket a surgical site and the one or more device tags includes a device tag located between the two markers.
18. (Currently Amended) A device comprising:
an insertion mechanism;
a plurality of markers, expandable from a stored state to an expanded annular state, the expanded annular state defining a hollow center in an axial direction and when in the expanded annular state, each of the plurality of markers defining an outer surface of sized and shaped for contact with a lumen in an organ;
and one or more tissue tags, respectively included in or connected to a corresponding one of the plurality of markers; wherein the plurality of markers are configured to be located within and deployed from the insertion mechanism into the lumen in the organ; and
wherein at least one of the plurality of markers or the one or more tissue tags includes or is made of magnetized material and has a magnetic orientation.
1. A surgical system comprising:
an insertion mechanism including a device comprising
plurality of markers, two or more of which are expandable rounded members that are positionable in a same lumen in an organ, the expandable rounded members being expandable from a stored state to an expanded state and when in the expanded state each of the expandable rounded members are configured to expand to move into contact with the lumen in the organ;
wherein each of the expandable rounded members comprise a tissue tag, each of the tissue tags being magnetized or comprising a magnet;
wherein the expandable rounded members are configured to be located within and deployed from the insertion mechanism into the lumen in the organ at a predetermined location relative to the target tissue;
each of the tissue tags being magnetized or comprising a magnet.
U.S. Patent No. 11,986,358 B2 fails to disclose that the one or more markers are configured to be deployed as one or more discrete structures separate from the insertion mechanism.
However, within the same field of endeavor, Mawad teaches a system and method for providing an embolic material to arteriovenous malformations (AVMs) without allowing undesired backflow or leakage of the embolic material past the catheter tip. The present system includes a microcatheter that is provided with a plug of expansile material adjacent to its tip according to [0009], the system comprising at least one annular ring 42 of reproduced fig. 4 above and [0015], [0019] calling for additional rings and wherein the one or more markers (the at least one annular ring 42 of reproduced fig. 4 above and [0015], [0019] calling for additional rings) are configured to be deployed as one or more discrete structures ([0015] states that the distal end 40 of distal body segment 14 includes at least one annular ring 42 on its outer surface with [0018] also indicating that it is preferred that ring 42 expand sufficiently slowly to allow the physician to position the catheter tip at the desired location before the vessel becomes occluded. On the other hand, if the catheter tip is positioned at the desired location, the physician can simply wait for the prescribed expansion period before continuing the procedure. Meaning the distal body segment 14 serves as the insertion mechanism from which the ring 42 is launched into place within the blood vessel) separate from the insertion mechanism([0021] When the desired amount of embolic material has been injected and it is desired to remove catheter 10 from the vessel, the catheter is pulled back from the vessel and the expansile ring 42 is detached from tip 40. The detachable expansile tip 42 remains in the feeding vessel held in place by the embolic material which would have refluxed around it).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure U.S. Patent No. 11,986,358 B2, the one or more markers are configured to be deployed as one or more discrete structures separate from the insertion mechanism, as taught by Mawad, to provide improved systems and methods for delivering therapy to a desired location ([0002], [0008]), with a reasonable expectation of success as U.S. Patent No. 11,986,358 B2 is also concerned with accurate placement of a therapy at a desired location col. 1, lines 41-46.
20. (Currently Amended) The device of claim 18, wherein all or a portion of the plurality of markers are made of nitinol.
2. The surgical system of claim 1, wherein all or a portion of the expandable rounded members of the plurality of markers are made of nitinol.
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 Farouk A Bruce whose telephone number is (408)918-7603. The examiner can normally be reached Mon-Fri 8-5pm PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Koharski can be reached at (571) 272-7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/FAROUK A BRUCE/ Examiner, Art Unit 3797
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