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 Amendment
This Office action is in response to the applicant’s communication filed 07/10/2026.
Status of the claims:
Claims 1, 4 – 9, 16, and 18 – 29 are pending in the application.
Claims 1, 9, and 16 are amended.
Claims 21 – 29 are new.
Claim Objections
The objections to claim 1 in the previous action dated 05/14/2026 have been withdrawn in light of the Applicant’s amendments filed 07/10/2026. Specifically, the objection to claim 1 regarding the phrase “the connection portion” has been withdrawn as the appropriate corrections have been made.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
The rejection of claims 19 and 20 under U.S.C 35 112(b) regarding indefiniteness, recited in the previous action dated 05/14/2026 have been maintained in and copied below for convenience. Specifically, the rejection of claim 19, regarding the lack of antecedent basis for "the core assembly shaft" in line 8, has been maintained as the no amendment has been made to address the issue. Additionally, in light of Applicant’s amendments, new rejections under U.S.C 35 112(b) regarding indefiniteness have been set forth below.
Claims 4, 5, 19, and 20 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites the limitation "the volume-reduced form" in line 2. There is insufficient antecedent basis for this limitation in the claim. Furthermore, the phrase renders the claim indefinite because it is unclear if Applicant is intending the phrase to mean one of the “first” and “second configurations” of the expandable mesh defined in claim 1. For the purpose of examination, the “volume-reduced form” will be read as the expandable mesh in the first, compressed, configuration.
Claim 19 recites the limitation "the core assembly shaft" in line 8. There is insufficient antecedent basis for this limitation in the claim. Furthermore, the phrase renders the claim indefinite because it is unclear if Applicant is intending the phrase to read “the core assembly” as previously defined or if Applicant is intending to further define the core assembly to include a shaft. For the purpose of examination, the Examiner will read the claim to mean the former, such that the phrase is read as “the core assembly”.
Claims 5 and 20 are rejected for being dependent on an indefinite claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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 and 6 – 8 are rejected under 35 U.S.C. 103 as being unpatentable over Oxley et al (US 2021/0137542 A1) (provisional filed on 11/08/2019) (herein referred to as Oxley 2021’) and in view of Oxley et al (WO 2017/070252 A1) (see attached PDF) (herein referred to as Oxley 2017’) and Willard et al (US 2015/0018818 A1).
Regarding claim 1, Oxley discloses a method (abstract, claims 1 – 13, paragraphs [0015 – 0023], [0038], [0040 – 0051], [0078], and Figs. 1 – 3, 9C) comprising:
disposing a medical device (stent 101/100) at a treatment site within a blood vessel (paragraphs [0040 – 0051], Figs. 1 – 2C, and claim 1), the medical device comprising:
an expandable mesh (stent 101/100) (paragraph [0041] and Fig. 9C) coupled to a distal end portion of a shaft (shaft 121) within a bodily lumen (paragraphs [0040 – 0051], Figs. 1 – 2C), wherein the expandable mesh comprises:
a tubular structure of interconnected struts (Fig. 9C) comprising a plurality of mesh cells having a proximal end and a distal end, the proximal end and the distal end being open (Fig. 9C);
a tapering portion connected to the proximal end of the tubular structure (Fig. 9C); and
a coupling region (region proximal to the proximal end of the taper) connected to a proximal end of the tapering portion (Fig. 9C), wherein the tapering portion is configured to converge at the coupling region (Fig. 9C), wherein the shaft (shaft 121) is connected to the expandable mesh via the coupling region (Fig. 9C);
a plurality of electrodes (electrodes 131) coupled to the expandable mesh (paragraph [0082], Fig. 9C, and claim 7); and
a plurality of electrically conductive leads (electrical lead wires 141 / bundle of strands 144) comprising traces (electrical lead wires 141), wherein each trace is electrically coupled to at least one of the plurality of electrodes (electrodes 131) (paragraphs [0054] and [0065]);
expanding the expandable mesh from a first configuration to a second configuration such that the expandable mesh expands into contact with a wall of the blood vessel (paragraph [0041] claim 1); and
electrically coupling the expandable mesh to a controller (paragraph [0043]); and
supplying an electrical signal to the plurality of electrodes via the traces (electrical lead wires 141) (paragraphs [0042 – 0043], [0045], [0047], [0053 – 0065]) (Examiner’s note: it should be understood that Oxley discloses supplying power to the mesh via the electrodes, and discloses electrically coupling the electrodes to the electrical lead wires 141. Therefore, the method inherently encompasses supplying the electrical signal to the electrodes via the traces).
However, Oxley 2021’ is silent regarding (i) wherein the shaft is conductive and (ii) an insulative ribbon comprising polyimide extending along a radially inward surface of the expandable mesh surrounding the traces.
As (i), Willard teaches a method comprising disposing a medical device (modulation system 100) comprising an expandable mesh (basket 114) coupled to a distal end of a conductive shaft (shaft 102; which equates to the shaft 121 of Oxley 2021’) (paragraphs [0036 – 0046], [0094 – 0095], and Fig. 2A) (Examiner’s note: as stated in paragraphs [0094 – 0095] the various components are made up of stainless steel, which is conductive, thus the shaft is relatively conductive).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify shaft 121 of Oxley to comprise stainless steel, based on the teachings of Willard, as stainless steel is a known material known to be used in similar medical device systems, and one of ordinary skill in the art would have a reasonable expectation of success in making such a modification, such that the results of the modification would be predictable and result in the modified device operating in the manner intended.
As to (ii), Oxley 2017’ teaches, in the same field of endeavor, a method comprising disposing a medical device (device 100) comprising a self-expandable mesh (self-expanding member 101) within a vessel (paragraph [0062]), a plurality of electrodes (electrodes 101) coupled to the expandable mesh, a plurality of electrically conductive leads (lead wires 141) comprising traces (lead wires 141) (paragraph [0069]), wherein the traces are grouped together in a single ribbon (bundle 144) extending along a radially inward surface of the expandable mesh surrounding the traces (paragraphs [0083] and Fig. 11), and wherein the traces (lead wires 141) are insulated via a polyimide (paragraph [0093]) (Examiner’s note: because the wires are disclosed and shown bundled together and disclosed as being insulated via the polyimide, it is well within the purview of one of ordinary skill in the art to have the bundle be the polyimide insulation that groups the wires together).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the bundle of traces of Oxley 2021’ to be encompassed within an insulative ribbon that extends along a radially inner surface of the expandable mesh, based on the teachings of Oxley 2017’, for the purpose of insulating the electrical wires so that the electrical path is isolated from the surrounding system.
Regarding claim 6, as discussed above, it would have been obvious to modify the system of Oxley 2021’ in view of Oxley 2017’ and Willard. Additionally, Oxley 2021’ discloses wherein the conductive shaft (shaft 121) comprises a conductive hypotube having a cut pattern (flexibility features 119) along at least a portion of a length thereof (paragraph [0078]).
Regarding claims 7 and 8, as discussed above, it would have been obvious to modify the system of Oxley 2021’ in view of Oxley 2017’ and Willard. Additionally, Oxley 2021’ discloses teaches wherein the expandable mesh comprises a stent or the expandable mesh comprises a stent retriever (Examiner’s note: a stent is defined as a tubular structure comprised of struts and a “stent retriever” is a device that can retrieve a stent. With that said, the expandable member 101/100 (i.e., the expandable mesh) is made up of struts and is capable of retrieving a stent).
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Oxley et al (US 2021/0137542 A1) (provisional filed on 11/08/2019) (herein referred to as Oxley 2021’) in view of Oxley et al (WO 2017/070252 A1) (see attached PDF) (herein referred to as Oxley 2017’), and Willard et al (US 2015/0018818 A1), as applied to claim 1 above, and further in view of Davidson (US 2015/0133990 A1) (previously cited).
Regarding claims 4 and 5, as discussed above, it would have been obvious to modify the system of Oxley 2021’ in view of Oxley 2017’ and Willard. Additionally, Oxley 2021’ discloses wherein the tubular structure is compressible in a volume-reduced state (paragraph [0041] and shown in Fig. 2B).
However, the combination is silent regarding (i) [claim 4] wherein the tubular structure forms lateral edges, and wherein in the volume-reduced form the tubular structure is curled up such that the lateral edges overlap (i.e., the method of how the expandable mesh compresses) and [claim 5] wherein after expanding the tubular structure, the amount of overlap of the lateral edges decreases compared to the volume-reduced form.
As to the above, Davidson teaches, in the same field of endeavor, a method of removing a thrombus from within a bodily lumen (abstract, paragraphs [0061 – 0073], and Figs. 1/2) comprising disposing a medical device comprising an expandable mesh (self-expandable member 102; which equates to the expandable stent 101/100 of Oxley 2021’) coupled to a distal end of a shaft (manipulation member 104; which equates to the shaft 121 of Oxley 2021’), wherein the expandable mesh comprises a tubular structure of interconnected struts comprising a plurality of mesh cells having a proximal end and a distal end, the proximal end and the distal end being open, a tapering portion (taper of proximal portion 122 – paragraph [0071]) connected to the proximal end of the tubular structure, a coupling region (region where proximal end 110 attaches to distal end of the manipulation member 104 – paragraph [0064]) connected to a proximal end of the tapering portion, wherein the tapering portion is configured to converge at the connection portion and the shaft connected to the expandable mesh via the coupling region (paragraphs [0061 – 0073], and Figs. 1,2), wherein the expandable mesh is electrically enhanced to draw in the thrombus / clot (paragraph [0108]). Additionally, Davidson teaches, in paragraph [0076], wherein during the clot retrieval process the shape and cell structure of the expandable mesh advantageously provides grip and retaining ability of the thrombus to the system via the individual struts. Additionally, Davidson teaches wherein the tubular structure (self-expandable member 102 – Davidson) forms lateral edges (edges 124/126) (paragraphs [0072], [0074], and Figs. 3,4A-D), and wherein in the volume-reduced form the tubular structure is curled up such that the lateral edges overlap (paragraph [0074]), and wherein after expanding the tubular structure, the amount of lateral edges overlap decreases compared to the volume-reduced form (Examiner’s note: as stated in paragraph [0075] there is a greater overlap occurs in more narrow vessels, and in narrower vessels the expandable member 102 does not expand as much as the expandable member 102 expands in a less narrow vessel, therefore, when going from a more compressed configuration to a more expanded configuration the amount of overlap of the edges decreases. Thus, when the expandable member 102 leaves the catheter and expands, the amount of overlap of the lateral edges will decrease).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the expandable mesh of Oxley 2021’ in view of Oxley 2017’ and Willard to incorporate lateral edges that can overlap in the manner claimed, based on the teachings of Davison, for the purpose of facilitating introduction of the expandable mesh into the microcatheter / delivery catheter (paragraph [0074] – Davidson).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Oxley et al (US 2021/0137542 A1) (provisional filed on 11/08/2019) (herein referred to as Oxley 2021’) in view of Oxley et al (WO 2017/070252 A1) (see attached PDF) (herein referred to as Oxley 2017’), and Willard et al (US 2015/0018818 A1), as applied to claim 1 above, and further in view of Taff et al (US 2018/0116717 A1) (previously cited).
Regarding claim 9, as discussed above, it would have been obvious to modify the system of Oxley 2021’ in view of Oxley 2017’ and Willard. Additionally, Oxley 2021’ discloses wherein the tubular structure is compressible in a volume-reduced state (paragraph [0041] and shown in Fig. 2B).
However, the combination is silent regarding (i) wherein supplying the electrical signal to the expandable plurality of electrodes via the traces comprises supplying a periodic waveform to the expandable mesh for a predetermined time period.
As to the above, Taff teaches, in the same field of endeavor, a method (abstract, paragraphs [0022 – 0031], [0041], [0046], [0051 – 0061], and Fig. 1) comprising disposing a medical device (electrode 3; which equates to the expandable mesh of Oxley 2017’) within a blood vessel (paragraph [0046]), the medical device (electrode 3) coupled to a distal end portion of a conductive shaft (conductive wire 5 and second electrode 26) communicating electrical signals (unipolar voltage) between electrodes (terminals 3t and 26t) of the medical device via separate conductive channels (conductive wire 5 and second electrode 26; which equate to the electrical lead wires 141 and electrodes 131 of Oxley 2021’) (paragraphs [0058 – 0062]). Additionally, Taff discloses wherein supplying an electrical signal to the medical device via a controller comprises supplying a periodic waveform to the expandable mesh for a predetermined time period of no more than 5 minutes / no more than 2 minutes (10s to less than 2 minutes) (paragraphs [0060 – 0061]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the controller and method of Oxley 2021’ in view of Oxley 2017’ and Willard to supply a periodic waveform to the leads / traces, based on the teachings of Taft, for the purpose of eliminating possible damage to the tissue (paragraph [0071] of Orion 2011/0301594 which is incorporated by reference in paragraph [0052] of Taft).
Claims 16, 18, 19, 21, 24, 25, and 27 – 29 are rejected under 35 U.S.C. 103 as being unpatentable over Oxley et al (US 2021/0137542 A1) (provisional filed on 11/08/2019) (herein referred to as Oxley 2021’) and in view of Oxley et al (WO 2017/070252 A1) (see attached PDF) (herein referred to as Oxley 2017’).
Regarding claims 16 and 19, Oxley 2021’ discloses Oxley discloses a method (abstract, claims 1 – 13, paragraphs [0015 – 0023], [0038], [0040 – 0051], [0078], and Figs. 1 – 3, 9C) comprising:
disposing a medical device (stent 101/100) at a treatment site within a blood vessel (paragraphs [0040 – 0051], Figs. 1 – 2C, and claim 1), the medical device comprising a self-expandable tubular mesh (stent 101/100) (paragraph [0041] and Fig. 9C) coupled to a distal end portion of a core assembly (shaft 121) (paragraphs [0040 – 0051], Figs. 1 – 2C), comprising at least two separate conductive channels (at least two of the electrical lead wires 141 in a bundle of strands 144) comprising traces (electrical lead wires 141) that provide electrical communication along the core assembly with corresponding electrodes (electrodes 131) of the medical device (paragraphs [0042 – 0043], [0045], [0047], [0053 – 0065]), wherein the self-expandable tubular mesh (stent 101/100) comprises:
a tubular structure of interconnected struts (Fig. 9C) comprising a plurality of mesh cells having a proximal end and a distal end, the proximal end and the distal end being open (Fig. 9C);
a tapering portion connected to the proximal end of the tubular structure (Fig. 9C); and
a coupling region (region proximal to the proximal end of the taper) connected to a proximal end of the tapering portion (Fig. 9C), wherein the tapering portion is configured to converge at the coupling region (Fig. 9C), wherein the shaft (shaft 121) is connected to the expandable mesh via the coupling region (Fig. 9C);
expanding the self-expandable tubular mesh at a treatment site within the blood vessel such that the self-expandable tubular mesh expands into contact with a wall of the blood vessel (paragraphs [0041 – 0050]); and
communicating electrical signals between the electrodes (electrodes 131) of the medical device and a controller via one or more of the at least two separate conductive channels (electrical lead wires 141) (paragraphs [0042 – 0043], [0045], [0047], [0053 – 0065]) (Examiner’s note: it should be understood that Oxley discloses supplying power to the mesh via the electrodes, and discloses electrically coupling the electrodes to the electrical lead wires 141. Therefore, the method inherently encompasses supplying the electrical signal to the electrodes via the traces).
However, Oxley 2021’ is silent regarding (i) an insulative ribbon comprising polyimide extending along a radially inward surface of the self-expandable tubular mesh encompassing the at least two separate conductive channels.
As to the above, Oxley 2017’ teaches, in the same field of endeavor, a method comprising disposing a medical device (device 100) comprising a self-expandable mesh (self-expanding member 101) within a vessel (paragraph [0062]), a plurality of electrodes (electrodes 101) coupled to the expandable mesh, a plurality of electrically conductive leads (lead wires 141) comprising traces (lead wires 141) (paragraph [0069]), wherein the traces are grouped together in a single ribbon (bundle 144) extending along a radially inward surface of the expandable mesh surrounding the traces (paragraphs [0083] and Fig. 11), and wherein the traces (lead wires 141) are insulated via a polyimide (paragraph [0093]) (Examiner’s note: because the wires are disclosed and shown bundled together and disclosed as being insulated via the polyimide, it is well within the purview of one of ordinary skill in the art to have the bundle be the polyimide insulation that groups the wires together).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the bundle of traces of Oxley 2021’ to be encompassed within an insulative ribbon that extends along a radially inner surface of the expandable mesh, based on the teachings of Oxley 2017’, for the purpose of insulating the electrical wires so that the electrical path is isolated from the surrounding system.
Regarding claim 18, as discussed above, it would have been obvious to modify the system of Oxley 2021’ in view of Oxley 2017’. Additionally, Oxley 2021’ makes obvious further comprising retracting the medical device (stent 101/100) from the treatment site by pulling the core assembly (shaft 121) along the blood vessel (Examiner’s note: the stent 101 is discussed as being removed from the system as mentioned in paragraph [0096]; and because the stent 101 is fixed to the shaft 121, it would be obvious and well within the purview of one of ordinary skill in the art to pull on the shaft 121 to remove the stent 101/100 from the body. Therefore, Oxley 2021’ makes obvious the limitation above).
Regarding claim 21, Oxley 2021’ discloses Oxley discloses a method (abstract, claims 1 – 13, paragraphs [0015 – 0023], [0038], [0040 – 0051], [0078], and Figs. 1 – 3, 9C) comprising:
disposing a medical device (stent 101/100) at a treatment site within a blood vessel (paragraphs [0040 – 0051], Figs. 1 – 2C, and claim 1),
the medical device comprising an interventional element having an expandable body (stent 101/100) (paragraph [0041] and Fig. 9C)
a plurality of electrodes (electrodes 131) coupled the body (stent 101/100) (paragraphs [0040 – 0051], Figs. 1 – 3), a plurality of electrically conductive leads (electrical lead wires 141 in a bundle of strands 144) comprising traces (electrical lead wires 141) electrically coupled to at least one of the electrodes (electrodes 131) (paragraphs [0042 – 0043], [0045], [0047], [0053 – 0065]),
expanding the body (stent 101/100) at a treatment site within the blood vessel such that the self-expandable tubular mesh expands into contact with a wall of the blood vessel (paragraphs [0041 – 0050]); and
communicating electrical signals between the electrodes (electrodes 131) of the medical device and a controller via the plurality of electrically conductive leads (electrical lead wires 141) (paragraphs [0042 – 0043], [0045], [0047], [0053 – 0065]) (Examiner’s note: it should be understood that Oxley discloses supplying power to the mesh via the electrodes, and discloses electrically coupling the electrodes to the electrical lead wires 141. Therefore, the method inherently encompasses supplying the electrical signal to the electrodes via the traces).
However, Oxley 2021’ is silent regarding (i) an insulative ribbon comprising polyimide extending along a radially inward surface of the body and encompassing the traces.
As to the above, Oxley 2017’ teaches, in the same field of endeavor, a method comprising disposing a medical device (device 100) comprising a self-expandable mesh (self-expanding member 101) within a vessel (paragraph [0062]), a plurality of electrodes (electrodes 101) coupled to the expandable mesh, a plurality of electrically conductive leads (lead wires 141) comprising traces (lead wires 141) (paragraph [0069]), wherein the traces are grouped together in a single ribbon (bundle 144) extending along a radially inward surface of the expandable mesh surrounding the traces (paragraphs [0083] and Fig. 11), and wherein the traces (lead wires 141) are insulated via a polyimide (paragraph [0093]) (Examiner’s note: because the wires are disclosed and shown bundled together and disclosed as being insulated via the polyimide, it is well within the purview of one of ordinary skill in the art to have the bundle be the polyimide insulation that groups the wires together).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the bundle of traces of Oxley 2021’ to be encompassed within an insulative ribbon that extends along a radially inner surface of the expandable mesh, based on the teachings of Oxley 2017’, for the purpose of insulating the electrical wires so that the electrical path is isolated from the surrounding system.
Regarding claim 24, as discussed above, it would have been obvious to modify the system of Oxley 2021’ in view of Oxley 2017’. Additionally, Oxley 2021’ discloses wherein the plurality of electrodes (electrodes 131) comprise an alloy of platinum and iridium (paragraph [0066]).
Regarding claim 25, as discussed above, it would have been obvious to modify the system of Oxley 2021’ in view of Oxley 2017’. Additionally, Oxley 2021’ discloses wherein the traces (electrical lead wires 141) comprise one or more of: gold, platinum, or a combination thereof (Examiner’s note: as stated in paragraph [0066] the electrodes are made up of platinum and are exposed sections of the lead wires 141; therefore the lead wires would also be composed of the platinum).
Regarding claim 27, as discussed above, it would have been obvious to modify the system of Oxley 2021’ in view of Oxley 2017’ to incorporate the insulated ribbon material surrounding the bundle 144 wherein the bundle is attached weaves in and out of the stent body (as shown in Fig. 11 of Oxley 2017’). Additionally, Oxley 2021’ makes obvious wherein the insulative ribbon is adhesively mounted to the radially inward surface of the body (Examiner’s note: as stated in paragraph [0077] Oxley 2021’ teaches it is known to use adhesive to attach structures to the body of the stent using adhesive. It would be obvious to one of ordinary skill in the art to attach the insulative ribbon (bundle / insulation 144) via an adhesive as using an adhesive to attach a structure (i.e., the bundle 144) to another structure (i.e., the stent 101/100) as those two structures are taught as being attached, and a person of ordinary skill in the art would have a reasonable expectation of success in attaching the insulative ribbon to the body via adhesive, and the results of the modification would have been predictable and resulted in the system being able to operate as intended).
Regarding claim 28, as discussed above, it would have been obvious to modify the system of Oxley 2021’ in view of Oxley 2017’. Additionally, Oxley 2021’ discloses wherein the medical device further comprises a conductive material (electrodes 131) applied to at least a portion of the interventional element via sputtering (paragraph [0087]).
Regarding claim 29, as discussed above, it would have been obvious to modify the system of Oxley 2021’ in view of Oxley 2017’. Additionally, Oxley 2021’ discloses wherein the body (stent 101/100) comprises a plurality of struts (paragraphs [0041 – 0047] and Figs. 1 – 3), and wherein the method further comprises positioning at least one of the plurality of electrodes (electrodes 131) such that it extends around some of a circumference of at least one of the struts (Examiner’s note: the electrodes 131 extend in all directions as they are three dimensional structures, and because they are positioned on the struts they inherently extend around some of the circumference of at least one of the struts).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Oxley et al (US 2021/0137542 A1) (provisional filed on 11/08/2019) (herein referred to as Oxley 2021’) in view of Oxley et al (WO 2017/070252 A1) (see attached PDF) (herein referred to as Oxley 2017’), as applied to claim 16 above, and further in view of Davidson (US 2015/0133990 A1) (previously cited).
Regarding claim 20, as discussed above, it would have been obvious to modify the system of Oxley 2021’ in view of Oxley 2017’. Additionally, Oxley 2021’ discloses wherein the tubular structure is compressible in a volume-reduced state (paragraph [0041] and shown in Fig. 2B).
However, the combination is silent regarding (i) wherein the tubular structure forms lateral edges, and wherein in the volume-reduced form the tubular structure is curled up such that the lateral edges overlap (i.e., the method of how the expandable mesh compresses) and wherein after expanding the tubular structure, the amount of overlap of the lateral edges decreases compared to the volume-reduced form.
As to the above, Davidson teaches, in the same field of endeavor, a method of removing a thrombus from within a bodily lumen (abstract, paragraphs [0061 – 0073], and Figs. 1/2) comprising disposing a medical device comprising an expandable mesh (self-expandable member 102; which equates to the expandable stent 101/100 of Oxley 2021’) coupled to a distal end of a shaft (manipulation member 104; which equates to the shaft 121 of Oxley 2021’), wherein the expandable mesh comprises a tubular structure of interconnected struts comprising a plurality of mesh cells having a proximal end and a distal end, the proximal end and the distal end being open, a tapering portion (taper of proximal portion 122 – paragraph [0071]) connected to the proximal end of the tubular structure, a coupling region (region where proximal end 110 attaches to distal end of the manipulation member 104 – paragraph [0064]) connected to a proximal end of the tapering portion, wherein the tapering portion is configured to converge at the connection portion and the shaft connected to the expandable mesh via the coupling region (paragraphs [0061 – 0073], and Figs. 1,2), wherein the expandable mesh is electrically enhanced to draw in the thrombus / clot (paragraph [0108]). Additionally, Davidson teaches, in paragraph [0076], wherein during the clot retrieval process the shape and cell structure of the expandable mesh advantageously provides grip and retaining ability of the thrombus to the system via the individual struts. Additionally, Davidson teaches wherein the tubular structure (self-expandable member 102 – Davidson) forms lateral edges (edges 124/126) (paragraphs [0072], [0074], and Figs. 3,4A-D), and wherein in the volume-reduced form the tubular structure is curled up such that the lateral edges overlap (paragraph [0074]), and wherein after expanding the tubular structure, the amount of lateral edges overlap decreases compared to the volume-reduced form (Examiner’s note: as stated in paragraph [0075] there is a greater overlap occurs in more narrow vessels, and in narrower vessels the expandable member 102 does not expand as much as the expandable member 102 expands in a less narrow vessel, therefore, when going from a more compressed configuration to a more expanded configuration the amount of overlap of the edges decreases. Thus, when the expandable member 102 leaves the catheter and expands, the amount of overlap of the lateral edges will decrease).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the expandable mesh of Oxley 2021’ in view of Oxley 2017’ to incorporate lateral edges that can overlap in the manner claimed, based on the teachings of Davison, for the purpose of facilitating introduction of the expandable mesh into the microcatheter / delivery catheter (paragraph [0074] – Davidson).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Oxley et al (US 2021/0137542 A1) (provisional filed on 11/08/2019) (herein referred to as Oxley 2021’) in view of Oxley et al (WO 2017/070252 A1) (see attached PDF) (herein referred to as Oxley 2017’), as applied to claim 21, and further in view of Divino et al (US 2016/0331377 A1) (previously cited).
Regarding claim 22, as discussed above, it would have been obvious to modify the system of Oxley 2021’ in view of Oxley 2017’. Additionally, Oxley 2021’ discloses further comprising electrically coupling a proximal portion of the plurality of electrically conductive leads to an electrical source comprising the controller (paragraph [0043]) (Examiner’s note: because the electrical leads 141 are what deliver the electrical energy to the electrodes, they inherently have to be coupled via their proximal ends to the power supply / controller).
However, the combination is silent regarding (i) a current generator.
As to the above, Divino teaches a medical device comprising an interventional element (implant) electrically coupled to a shaft (delivery wire 44; which equates to the electrical leads and electrodes of Oxley 2021’) via an current generator (a part of the power supply 46; which equates to the power supply source of Oxley 2021’), and a controller (controller of power supply 46), forming a part of the current generator (current generator), for communicating electrical signals between electrodes of the medical device and the current generator (abstract, paragraphs [0033 – 0035] and Figs. 1A/B).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the system of Oxley 2021’ in view of Oxley 2017’ to incorporate the current generator with the controller, based on the teachings of Divino, for the purpose of allowing the user to control the supply of electrical signals to the expandable mesh, and allow the user to regulate the current of the electrical signals thereby broadening the scope of the operation.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Oxley et al (US 2021/0137542 A1) (provisional filed on 11/08/2019) (herein referred to as Oxley 2021’) in view of Oxley et al (WO 2017/070252 A1) (see attached PDF) (herein referred to as Oxley 2017’) and Divino et al (US 2016/0331377 A1) (previously cited), as applied to claim 22, and further in view of Steinke (US 2008/0262489 A1).
Regarding claim 23, as discussed above, it would have been obvious to modify the system of Oxley 2021’ in view of Oxley 2017’. Additionally, Oxley 2021’ discloses the controller causes a power source to deliver the electrical current (paragraph [0043]).
However, the combination is silent regarding (i) wherein the controller comprises a processor and a memory that stores instructions for causing the power source to deliver the electrical current.
As to the above, Steinke teaches a medical device (expandable structure 26; which equates to the stent 101/100 of Oxley 2021’) electrically coupled to a controller (controller 47 and processor 39) with a processor (which equates to the controller of Oxley 2021’) for controlling / sending electrical energy from a power supply to the medical device, wherein the controller / processor comprises a memory that stores instructions for implementing any methods herein (which includes sending the electrical signals from the RF generator) (paragraph [0089]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the controller of Oxley 2021’ in view of Oxley 2017’ and Divino to incorporate a processor with memory / stored instructions, based on the teachings of Steinke, for the purpose of aiding the user in operating the system.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Oxley et al (US 2021/0137542 A1) (provisional filed on 11/08/2019) (herein referred to as Oxley 2021’) in view of Oxley et al (WO 2017/070252 A1) (see attached PDF) (herein referred to as Oxley 2017’), as applied to claim 21, and further in view of Hill et al (US 2015/0105772 A1).
Regarding claim 26, as discussed above, it would have been obvious to modify the system of Oxley 2021’ in view of Oxley 2017’. Additionally, Oxley 2021’ discloses the lead wires are insulated (paragraph [0066]).
However, the combination is silent regarding (i) individually insulating the lead wires within the ribbon of insulation and with parylene.
As to the above, Hill teaches, in the same field of endeavor, an electrically conductive interventional medical device (expandable basket 110) with an insulative coating of parylene (abstract, paragraph [0057], and Fig. 2).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the lead wires of Oxley 2021’ to be insulated from each other via parylene, as Oxley 2021’ discloses it is known to insulate the electrical leads and Hill teaches parylene is a known material used for electrically insulating within medical devices used within the body; and one of ordinary skill in the art would have a reasonable expectation of success in electrically insulating the electrical lead wires from each other via the parylene such that the results of the modification would be predictable and the modified device would operate as intended.
Response to Arguments
Applicant’s arguments, filed 07/10/2026, with respect to the rejection of claims 1 and 16 under Taff, Davidson, and Divino have been considered but are moot as the arguments are directed to Applicant’s amendments, and the previous rejection of the claims has been withdrawn in light of said amendments. Specifically, the rejections were withdrawn because the combination of Taff, Davidson, and Divino does not teach an insulated ribbon extending along an inner surface of the expandable mesh / tubular body. It is noted that a new rejection has been made over Oxley 2021’ and Oxley 2017’, with or without Willard. The teachings of Oxley 2021’ and Oxley 2017’ are relied upon for teaching the newly added limitations as discussed above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andrew Restaino whose telephone number is (571)272-4748. The examiner can normally be reached Mon - Fri 8:00 - 4:00 ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Andrew Restaino/Primary Examiner, Art Unit 3771
Prosecution Insights