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 allowance of the claims.
Applicant's arguments with respect to the rejection of claims 1, 10 and 18 in Applicant’s responses filed 10/10/2025 have been fully considered but they are not persuasive.
Applicant’s amendments to claims 1, 10, and 18 require an annular expanded state, of the expandable rounded members, defining a hollow center in an axial direction and when in the expanded annular state, an outer surface of each of the expandable rounded members contact with a lumen in an organ.
Applicant remarks on page 7 of Applicant’s responses that Geoffrion (US 6338709 B1) fails to teach the limitation above because the expanded braids of Geoffrion, as depicted in fig. 15, are in a shape of a disk, and not annular in nature.
Examiner respectfully disagrees.
Geoffrion’s braids 1010 and 1000 are, in fact, annular in shape. The planar depiction of the apparatus setup in fig. 15 deprives a viewer of the annular shape of the braids 1000 and 1010 in that the distal braids 1000 and the proximal braids 1010 surround the radiation catheter 1020 and the proximal catheter 1025, respectively, in an annular manner.
Take for instance, distal braid 1100 depicted in reproduced fig. 16A below as disk shaped. However, fig. 16B shows distal braid 1100 only partially surrounding a circumference of the radiation catheter 1120, and described in column 16, lines 24-32 as the following: “The self-expanding braids 1100 and 1110 are shown in FIGS. 16A and 16B as extending less than 360 degrees around the radiation catheter 1120, thereby reducing the risk of clot formation and permitting blood to flow around the braids. For example, the distal braid 1100 is illustrated in FIG. 16B as supporting the radiation catheter 1120, but its radial extent around the radiation catheter is limited. Likewise, the proximal braid 1110 extends only partially around the radiation catheter 1120”.
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Col. 15, lines 49-51 state that “Another embodiment illustrating the use of braids is illustrated in FIG. 15, which is substantially analogous to the two-balloon embodiment of FIGS. 10A and 10B”, where the balloons in figs. 10A and 10B are taught to be disposed around the radioactive source according to col. 3, lines 12-18. The above at least suggests the recited expanded annular state or configuration of the expandable rounded members.
Applicant’s arguments with respect to Huelman (US 20160220314 A10 are moot as Geoffrion has been demonstrated as teaching the limitation in question.
Withdrawn Rejections
Pursuant of Applicant’s amendments filed 10/10/2025, the rejection of claim 12 under 35 U.S.C. 112(b) has been withdrawn.
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 1-10, 13, and 16-20 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 1, Geoffrion teaches a device (see reproduced fig. 15 below) comprising:
one or more markers(see braids 1000 and 1010 of fig. 15), some or all of which are expandable rounded members that are expandable from a stored state to an expanded annular state (col. 15, lines 64-67 state that “braids 1000 and 1010 are illustrated as being self-expanding. For example, the braids 1000 and 1010 may fit within a sheath 1050 before they are deployed, and be collapsed by the sheath 1050 after treatment but before the device is removed from the patient”. The expandable braids 1000 and 1010 deploy from a smaller annular shape surrounding the radiation catheter 1020 and the proximal catheter 1025, respectively, into bigger annular shape surrounding the radiation catheter 1020 and the proximal catheter 1025, respectively. Col. 15, lines 49-51 state that “Another embodiment illustrating the use of braids is illustrated in FIG. 15, which is substantially analogous to the two-balloon embodiment of FIGS. 10A and 10B”, where the balloons in figs. 10A and 10B are taught to be disposed around the radioactive source according to col. 3, lines 12-18), the expanded annular state defining a hollow center in an axial direction (see self-expandable oblong shaped braids in fig. 15 disposed within the same lumen of the organ. Col. 3, lines 12-16 state that “a radiation device for treating a segment of a vessel in a patient comprises a catheter for delivering radiation, a radioactive source in proximity with the radiation catheter, a balloon around the radioactive source, and a lumen within the radiation catheter that is in fluid communication with the balloon, permitting inflation and deflation of the balloon”, at least suggesting that the balloons 1000 and 1010 form an annular shape with a hollow center for receiving the proximal catheter 1025 and radiation catheter 1020) and when in the expanded annular state, an outer surface of each of the expandable rounded members contact with a lumen in an organ (see fig. 15 which clearly shows the braids in contact with a lumen and col. 15, lines 61-67 for the self-expanding mechanism of the braids which expand to fill the lumen of a vessel. Annotations to fig. 15 show outer surfaces of braids 1000 and 1010 in contact with the inner wall of the lumen of the vessel); and
wherein the expandable rounded members are configured to be located within and deployed from an insertion mechanism (sheath 1050 of fig. 15) into the lumen in the organ(col. 15, lines 61-67 indicates that the self-expanding oblong braids may fit within the sheath 1050 before and after they are deployed and col. 15, lines 51-56 indicate that the deployment occurs at a stenosis site); and
[AltContent: arrow][AltContent: arrow][AltContent: textbox (Outer surfaces of the braids 1000 and 1010 in contact with an inner surface of a lumen of a vessel)]
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Geoffrion fails to teach one or more tissue tags included in or connected to the expandable rounded members or the expandable rounded members being made of a magnetized material; and wherein at least one of the markers and the tissue tags is made of the magnetized material and has a magnetic orientation.
However, Huelman teaches a surgical guidance system (see paragraph 31), 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 tags included in or connected to the expandable rounded members or the expandable rounded members being made of a magnetized material (the tags 42 of figs. 5, 7, and 8 are magnets, with paragraph 36 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 markers and the tissue tags is made of the magnetized material and has a magnetic orientation (figs. 7-8 demonstrate the poles of the magnets. Also see paragraph 52).
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’s radiation catheter, to include one or more tissue tags included in or connected to the expandable rounded members or the expandable rounded members being made of a magnetized material; and wherein at least one of the markers and the tissue tags 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 paragraph 12 of Huelman).
Regarding claim 2, Geoffrion in view of Huelman teaches all the limitations of claim 1.
Geoffrion 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 (the abstract denotes that the radiation delivering catheter is positioned in a blood vessel).
Regarding claim 3, Geoffrion in view of Huelman teaches all the limitations of claim 1.
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).
Regarding claim 4, Geoffrion in view of Huelman teaches all the limitations of claim 1.
Geoffrion does not teach wherein the expandable rounded members include a hollow center.
However, Huelman further teaches wherein the expandable rounded members include a hollow center (see magnets 76 of fig. 8 and paragraph 46 for the description of the general configuration in fig. 5).
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’s braids, with Huelman’s rigid tubular magnets with hollow centers to improve safety of the procedure. See paragraph 12 of Huelman.
Regarding claim 5, Geoffrion in view of Huelman teaches all the limitations of claim 1.
Geoffrion does not teach wherein some of the one or more markers include one or more solid markers that are deployed into the lumen.
However, Huelman further teaches wherein some of the one or more markers include one or more solid markers that are deployed into the lumen (see paragraphs 46-47 for the description of the magnets which have a rigid tubular shape).
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’s braids wherein some of the one or more markers include one or more solid markers that are deployed into the lumen, as taught by Huelman to improve safety of the procedure. See paragraph 12 of Huelman.
Regarding claim 6, Geoffrion in view of Huelman teaches all the limitations of claim 5.
Geoffrion fails to teach wherein the one or more solid markers comprise a predefined size.
However, Huelman further teaches wherein the one or more solid markers comprise a predefined size (see paragraphs 46-47 for the description of the magnets which have a rigid tubular shape).
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’s braids wherein the one or more solid markers comprise a predefined size, as taught by Huelman to improve safety of the procedure. See paragraph 12 of Huelman.
Regarding claim 7, Geoffrion in view of Huelman teaches all the limitations of claim 5.
Geoffrion fails to teach wherein the one or more solid markers comprise a predefined shape.
However, Huelman further teaches wherein the one or more solid markers comprise a predefined shape (see paragraphs 46-47 for the description of the magnets which have a rigid tubular shape).
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’s braids wherein the one or more solid markers comprise a predefined shape, as taught by Huelman to improve safety of the procedure. See paragraph 12 of Huelman.
Regarding claim 8, Geoffrion in view of Huelman teaches all the limitations of claim 5.
Geoffrion fails to teach wherein the one or more solid markers comprise a predefined size and a predefined shape.
However, Huelman further teaches wherein the one or more solid markers comprise a predefined size and a predefined shape (see paragraphs 46-47 for the description of the magnets which have a rigid tubular shape).
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’s braids wherein the one or more solid markers comprise a predefined size and a predefined shape, as taught by Huelman rigid tubular magnets to improve safety of the procedure. See paragraph 12 of Huelman.
Regarding claim 9, Geoffrion in view of Huelman teaches all the limitations of claim 1.
Geoffrion further teaches the insertion mechanism for deploying the expandable rounded members (col. 15, lines 61-67 indicates that the self-expanding oblong braids may fit within the sheath 1050 before and after they are deployed and col. 15, lines 51-56 indicate that the deployment occurs at a stenosis site).
Regarding claim 10, , Geoffrion teaches a surgical system (see fig. 15) comprising:
comprising;
one or more tissue effecting elements (radiation catheter 1020) including a tip (see fig. 15 for the end of the radiation catheter 1020); and
an insertion mechanism (sheath 1050 of fig. 15) configured to deploy a device (see braids 1000 and 1010 of fig. 15) into a lumen of an organ at a predetermined location relative to a target tissue(col. 15, lines 61-67 indicates that the self-expanding oblong braids may fit within the sheath 1050 before and after they are deployed and col. 15, lines 51-56 indicate that the deployment occurs at a stenosis site), the device including:
one or more markers(see braids 1000 and 1010 of fig. 15), some or all of which are expandable rounded members that are expandable from a stored state to an expanded annular state (col. 15, lines 64-67 state that “braids 1000 and 1010 are illustrated as being self-expanding. For example, the braids 1000 and 1010 may fit within a sheath 1050 before they are deployed, and be collapsed by the sheath 1050 after treatment but before the device is removed from the patient”. The expandable braids 1000 and 1010 deploy from a smaller annular shape surrounding the radiation catheter 1020 and the proximal catheter 1025, respectively, into bigger annular shape surrounding the radiation catheter 1020 and the proximal catheter 1025, respectively. Col. 15, lines 49-51 state that “Another embodiment illustrating the use of braids is illustrated in FIG. 15, which is substantially analogous to the two-balloon embodiment of FIGS. 10A and 10B”, where the balloons in figs. 10A and 10B are taught to be disposed around the radioactive source according to col. 3, lines 12-18), the expanded annular state defining a hollow center in an axial direction (see self-expandable oblong shaped braids in fig. 15 disposed within the same lumen of the organ. Col. 3, lines 12-16 state that “a radiation device for treating a segment of a vessel in a patient comprises a catheter for delivering radiation, a radioactive source in proximity with the radiation catheter, a balloon around the radioactive source, and a lumen within the radiation catheter that is in fluid communication with the balloon, permitting inflation and deflation of the balloon”, at least suggesting that the balloons 1000 and 1010 form an annular shape with a hollow center for receiving the proximal catheter 1025 and radiation catheter 1020) and when in the expanded annular state, an outer surface of each of the expandable rounded members contact with the lumen (see fig. 15 which clearly shows the braids in contact with a lumen and col. 15, lines 61-67 for the self-expanding mechanism of the braids which expand to fill the lumen of a vessel. Annotations to fig. 15 show outer surfaces of braids 1000 and 1010 in contact with the inner wall of the lumen of the vessel); and
Geoffrion fails to teach one or more device tags included in or having a magnetic orientation providing an information of positional relationship with the tip of the one or more tissue effecting elements; one or more tissue tags connected to the expandable rounded members or the expandable rounded members being made of a magnetized material; wherein at least one of the markers and the tissue tags is made of the magnetized material and has a magnetic orientation.
However, Huelman teaches a surgical guidance system (see paragraph 31), 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) including one or more device tags included in (proximity sensor 24 of fig. 11) or having a magnetic orientation providing an information of positional relationship with the tip of the one or more tissue effecting elements (paragraph 31 discloses that “a proximity sensor 24 attached to the surgical instrument 22 and configured to detect the intensity of the detectable field”); one or more tissue tags connected to the expandable rounded members or the expandable rounded members being made of a magnetized material (the tags 42 of figs. 5, 7, and 8 are magnets according to paragraph 36); wherein at least one of the markers and the tissue tags is made of the magnetized material and has a magnetic orientation (figs. 7-8 demonstrate the poles of the magnets. Also see paragraph 52).
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’s braids with one or more device tags included in or having a magnetic orientation providing an information of positional relationship with the tip of the one or more tissue effecting elements; one or more tissue tags connected to the expandable rounded members or the expandable rounded members being made of a magnetized material; wherein at least one of the markers and the tissue tags is made of the magnetized material and has a magnetic orientation, as taught by Huelman rigid tubular magnets to improve safety of the procedure. See paragraph 12 of Huelman.
Regarding claim 13, Geoffrion in view of Huelman teaches all the limitations of claim 10 above.
Geoffrion 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 (see paragraph 57).
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’s braids wherein the tissue effecting element is a blade or a needle, as taught by Huelman rigid tubular magnets to improve safety of the procedure. See paragraph 12 of Huelman.
Regarding claim 16, Geoffrion in view of Huelman teaches all the limitations of claim 10 above.
Geoffrion does not 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.
Huelman further teaches a display system (notification unit 28 (which is a touchscreen display according to paragraph 65)) configured to indicate a proximity of the tip of the one or more tissue effecting elements to the one or more markers (see paragraph 65 for the notification based on the proximity information garnered in paragraph 32).
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’s braids with 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 rigid tubular magnets to improve safety of the procedure. See paragraph 12 of Huelman.
Regarding claim 17, Geoffrion in view of Huelman teaches all the limitations of claim 10 above.
Geoffrion further teaches wherein the markers comprise two markers that bracket a surgical site (see fig. 15) but fails to teach that the one or more device tags includes a device tag located between the two markers.
However, Huelman teaches 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 Geoffrion in view of Huelman is considered capable of performing as claimed at least during an insertion of the surgical instrument 22 into the area between the two tags.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to provide the proximity sensor 24 on the distal end of Geoffrion’s radiation catheter 1020, so that as depicted in fig. 15, the proximity sensor 24 resides the between the two expandable braids 1010 and 1000 during ablation of the stenosis site for improved safety of the procedure. See paragraph 12 of Huelman.
Regarding claim 18, Geoffrion teaches a device (see fig. 15 for the catheter) comprising:
an insertion mechanism (sheath 1050 of fig. 15 and col. 15);
a plurality of markers(see braids 1000 and 1010 of fig. 15), some or all of which are expandable rounded members that are expandable from a stored state to an expanded annular state (col. 15, lines 64-67 state that “braids 1000 and 1010 are illustrated as being self-expanding. For example, the braids 1000 and 1010 may fit within a sheath 1050 before they are deployed, and be collapsed by the sheath 1050 after treatment but before the device is removed from the patient”. The expandable braids 1000 and 1010 deploy from a smaller annular shape surrounding the radiation catheter 1020 and the proximal catheter 1025, respectively, into bigger annular shape surrounding the radiation catheter 1020 and the proximal catheter 1025, respectively. Col. 15, lines 49-51 state that “Another embodiment illustrating the use of braids is illustrated in FIG. 15, which is substantially analogous to the two-balloon embodiment of FIGS. 10A and 10B”, where the balloons in figs. 10A and 10B are taught to be disposed around the radioactive source according to col. 3, lines 12-18) the expanded annular state defining a hollow center in an axial direction (see self-expandable oblong shaped braids in fig. 15 disposed within the same lumen of the organ. Col. 3, lines 12-16 state that “a radiation device for treating a segment of a vessel in a patient comprises a catheter for delivering radiation, a radioactive source in proximity with the radiation catheter, a balloon around the radioactive source, and a lumen within the radiation catheter that is in fluid communication with the balloon, permitting inflation and deflation of the balloon”, at least suggesting that the balloons 1000 and 1010 form an annular shape with a hollow center for receiving the proximal catheter 1025 and radiation catheter 1020) and when in the expanded annular state, an outer surface of each of the expandable rounded members contact with a lumen in an organ (see fig. 15 which clearly shows the braids in contact with a lumen, which defines a longitudinal axis and col. 15, lines 61-67 for the self-expanding mechanism of the braids which expand to fill the lumen of a vessel, the centerline of the vessel defines a longitudinal axis. Annotations to fig. 15 show outer surfaces of braids 1000 and 1010 in contact with the inner wall of the lumen of the vessel); and
wherein the expandable rounded members are configured to be located within and deployed from the insertion mechanism into the lumen in the organ (col. 15, lines 61-67 indicates that the self-expanding oblong braids may fit within the sheath 1050 before and after they are deployed and col. 15, lines 51-56 indicate that the deployment occurs at a stenosis site)
Geoffrion fails to teach one or more tissue tags included in or connected to the expandable rounded members, each of the tissue tags being magnetized or comprising a magnet; wherein at least one of the markers and the tissue tags has a magnetic orientation.
However, Huelman teaches a surgical guidance system (see paragraph 31), 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), the one or more tissue tags included in or connected to the expandable rounded members or the expandable rounded members being made of a magnetized material (the tags 42 of figs. 5, 7, and 8 are magnets); and wherein at least one of the markers and the tissue tags has a magnetic orientation (figs. 7-8 demonstrate the poles of the magnets. Also see paragraph 52).
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’s radiation catheter, to include one or more tissue tags included in or connected to the expandable rounded members, each of the tissue tags being magnetized or comprising a magnet; wherein at least one of the markers and the tissue tags 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 paragraph 12 of Huelman).
Regarding claim 19, Geoffrion in view of Huelman teaches all the limitations of claim 18 above.
Geoffrion 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 (the abstract denotes that the radiation delivering catheter is positioned in a blood vessel).
Regarding claim 20, 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).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Geoffrion, et al., US 6338709 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, Geoffrion in view of Huelman teaches all the limitations of claim 10 above.
Geoffrion 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, Spence teaches a system for applying fasteners to a region of interest for surgical procedure (see paragraph 26), including guide magnets provided on a distal end of catheters and using the repelling and attractive forces of the poles to guide the catheters, such as Geoffrion’s radiation catheter 1020, to a region of interest. See paragraph 26 of Spence.
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’s braids, 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. See paragraph 23 of Spence.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Geoffrion, et al., US 6338709 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.
Regarding claim 12, Geoffrion in view of Huelman teaches all the limitations of claim 10 above.
Geoffrion 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, 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), 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 paragraph 656), 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 (paragraph 659 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.”), the target tissue and the one or more tissue tags are displaced as the one or more device tags are moved towards the target target tissue and the one or more tissue tags (paragraph 659 further states that “A separate electrode catheter (not shown) may be advanced within the frame 11300 and manipulated such that the electrode(s) are delivered through openings in the wire mesh of the frame 11300 to contact the vessel wall. The frame 11300 may advantageously stabilize 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). In some cases, these contact forces might otherwise increase the contact area between the electrode and vessel wall and restrict blood flow near the electrode, which may impair cooling and increase vessel injury.”)
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, the target target tissue and the one or more tissue tags are displaced as the one or more device tags are moved towards the target target tissue and 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).
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Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Geoffrion, et al., US 6338709 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, Geoffrion in view of Huelman teaches all the limitations of claim 10 above.
Geoffrion 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, De Vreis teaches a brachytherapy system, and brachytherapy position and verification system (see abstract) comprising a verification element (paragraph 44), where the brachytherapy system includes an applicator 4 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 (paragraph 71 notes 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 Geoffrion’s system, 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, see paragraph 10 of De Vreis, while also ensuring safety during treatment, paragraph 70 of De Vreis.
Regarding claim 15, Geoffrion in view of Huelman teaches all the limitations of claim 10 above.
Geoffrion 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 (paragraph 44), 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 (paragraphs 44-45); means (paragraph 57) 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 (paragraph 69 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 Geoffrion’s system, 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, see paragraph 10 of De Vreis, while also ensuring safety during treatment, paragraph 70 of De Vreis.
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,986,358 B2. 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.
Conclusion
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/FAROUK A BRUCE/ Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/ Supervisory Patent Examiner, Art Unit 3797