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
Applicant's arguments filed 4/29/2026 have been fully considered but they are not persuasive.
Regarding claim 1, Applicant contends that Muessig (US 2016/0067474 A1)(previously of record) does not expressly or adequately disclose the limitations of “wherein the radiopaque marker comprises a V-shaped marker” and “wherein determining the rotational orientation of the expandable structure comprises determining whether the V-shaped marker is right-side-up or upside-down” on the grounds that the previous rejected improperly conflated the portion of the strut(s) (12) comprising radiopaque material (per Muessig Para. [0030] and [0069]-[0070]) and the V-shaped orientation of the struts themselves to meet the “V-shaped marker” limitation. Applicant contends that the V-shaped orientation of the struts are merely a structural configuration to form the support member framework and are not themselves discrete V-shaped markers” as required by the claim language. Muessig therefore does not disclose a radiopaque marker that is V-shaped, but instead merely discloses that the struts are radiopaque without specifying wherein the radiopaque marker is “V-shaped”.
The Examiner respectfully disagrees with the proposed arguments. While Muessig does not expressly state “wherein the struts comprise V-shaped radiopaque markers”, Muessig provides adequate disclosure of wherein the struts may either comprise radiopaque markers or be formed from radiopaque material to aid a user in determining the orientation of the device under fluoroscopic guidance (see Para. [0030] and [0069]-[0070]). With the struts being radiopaque, the “turnaround points” along the length of the strut in which the direction of the strut abruptly changes can be viewed as “V-shaped” due to this sharp turnaround resulting in a “V-shaped” structural formation. Combined with the disclosure of wherein the strut(s) are radiopaque, the struts would thus comprise “V-shaped” radiopaque marker portions along the length thereof that a user would be able to monitor and track to determine the orientation of the device per Para. [0030] and [0069]-[0070] since this is disclosed to be the function and purpose of the radiopaque material/markers. Therefore, while Muessig may not provide an express written citation of “V-shaped” radiopaque markers, the inherent structure of the struts, combined with the radiopaque material along the length thereof, the resulting configuration would reasonably constitute “V-shaped” radiopaque markers used to determine the orientation of the device during navigation to a target site.
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.
Claim(s) 34 and 37- 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Muessig (US 2016/0067474 A1)(previously of record).
Regarding claim 34, Muessig discloses:
A method of deploying an expandable structure (support member 6) (see Figs. 1 and 3; see also Para. [0047]) within a vessel (see Para. [0012]-[0014] and [0048]) for stimulation of nerves surrounding the vessel (see Para. [0012] and [0047]), the method comprising:
inserting the expandable structure (support member 6) within the vessel to a target location along a length of the vessel (see Para. [0012]-[0014] and [0047]), the expandable structure (support member 6) comprising a plurality of electrodes (electrodes 14) (see Figs. 3-4 and Para. [0057] mentioning a “plurality of electrodes 14”) adapted to be activated to cause stimulation of the nerves surrounding the vessel (see Para. [0012]-[0014], [0047] and [0058]) and a radiopaque marker (see Para. [0030] and [0069]-[0070] mentioning wherein at least one portion of the support members (6), struts (12), tether, or filaments (3) may either include radiopaque markers or be formed from radiopaque material that is visual under x-ray fluoroscopy; for the purposes of examination, the struts (12) are interpreted to comprise the radiopaque markers) positioned so as not to longitudinally overlap with any of the plurality of electrodes on the expandable structure (see Examiner’s Diagram of Fig. 3 below; electrodes (14) are protruding from designated radiopaque struts (12) and thus do not longitudinally overlap therewith), wherein the radiopaque marker comprises a V-shaped marker (see Figs. 3 showing wherein the struts (12) comprise V-Shaped portions; the “turnaround points” along the length of the struts (12) constitute “V-shaped” portions; combined with the radiopaque material used to form the struts, the resulting structure constitutes “V-shaped markers”); and
fully expanding the expandable structure within the vessel (see Para. [0011], [0024]-[0026] and [0047]).
However, while Muessig discloses wherein x-ray imaging is done to visualize the radiopaque elements of the device during navigation and use (see Para. [0030] and [0069]-[0070]) and to correct or adjust the position of the device within the target blood vessel lumen depending on the alignment of the one or more radiopaque elements (see Para. [0030]), Muessig does not expressly disclose the steps of:
imaging the expandable structure using an imaging modality adapted to facilitate visualization of radiopaque material;
determining a rotational orientation of the expandable structure based the radiopaque marker prior to fully expanding the expandable structure to contact a wall of the vessel; wherein determining the rotational orientation of the expandable structure comprises determining whether the V-shaped marker is right-side-up or upside-down;
adjusting the rotational orientation of the expandable structure based on the determining the rotational orientation of the expandable structure.
However, since Muessig provides express disclosure of wherein x-ray imaging is done to visualize the radiopaque elements of the device during navigation and use (see Para. [0030] and [0069]-[0070]) and, depending on the orientation of one or more radiopaque markers, a user can determine the orientation of device to correct or adjust the position of the device within the target blood vessel lumen depending on the alignment of the one or more radiopaque elements (see Para. [0030]), it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have performed the steps of:
imaging the expandable structure using an imaging modality adapted to facilitate visualization of radiopaque material (see Para. [0030] and [0069]-[0070] mentioning wherein x-ray imaging is done to visualize the radiopaque elements of the device during navigation and use; during x-ray imaging, a user would be able to visualize the radiopaque material of the radiopaque elements of the device to allow for proper placement within a target vessel as an inherent step in guiding the device to a target location);
determining a rotational orientation of the expandable structure based the radiopaque marker prior to fully expanding the expandable structure to contact a wall of the vessel (see Para. [0030] and [0069]-[0070] mentioning wherein x-ray fluoroscopy is utilized to determine the location and rotational orientation of the device during navigation and implantation; it would have been obvious to one of ordinary skill in the art to have continuously monitored at least one radiopaque element to ensure proper rotational alignment prior to fully expanding the device at a target location to reduce risk of damage to the vessel and/or surrounding nerves);
wherein determining the rotational orientation of the expandable structure comprises determining whether the V-shaped marker is right-side-up or upside-down (see Para. [0030] and [0069]-[0070]; depending on the V-Shaped section of the struts (12) a user is monitoring, the inherent V-shape and orientation of the struts would cause the radiopaque V-Shaped section of the monitored strut section to either be right-side up or upside-down; see Examiner’s Diagram of Fig. 3 below pointing to a designated exemplary V-shaped radiopaque strut section that a user may use to orient the device; it would have been obvious to one of ordinary skill in the art, during the navigation phase of the device, to have continuously monitored the location and orientation of the device based on readings from at least one radiopaque element to ensure proper placement within a target vessel);
adjusting the rotational orientation of the expandable structure based on the determining the rotational orientation of the expandable structure (see Para. [0030] and [0069]-[0070] mentioning wherein the location and rotational orientation of the device is continuously monitored under x-ray fluoroscopy during navigation and implantation; one of ordinary skill would ensure proper orientation of the device during navigation as part of the monitoring process to ensure the device is deployed in the proper orientation to reduce the risk of damage to the target location).
Examiner’s Diagram of Fig. 3
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Regarding claim 37, Muessig discloses the method of claim 34, Muessig further discloses wherein the radiopaque marker is positioned distal to any of the plurality of electrodes (see Examiner’s Diagram of Fig. 3 above showing an electrode positioned proximally of the designated radiopaque section of the strut).
Regarding claim 38, Muessig discloses the method of claim 34, Muessig further discloses wherein the radiopaque marker is circumferentially aligned with at least one of the plurality of electrodes (see Examiner’s Diagram of Fig. 3 above showing wherein the labeled electrodes (14) are circumferentially aligned with sections of the struts).
Regarding claim 40, Muessig discloses all of the limitations of the method of claim 38.
However, Muessig does not expressly disclose wherein the radiopaque marker is circumferentially aligned with a distal-most electrode of the plurality of electrodes
However, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have placed a radiopaque marker circumferentially aligned with a distal-most electrode of the plurality of electrodes since Muessig only discloses wherein a portion of the struts can be radiopaque but does not give an express location for the radiopaque section, it is a matter of obviousness to have any section of the struts comprise the radiopaque section. It would have therefore been obvious to one of ordinary skill in the art to have placed at least one radiopaque marker to be aligned with a distal-most electrode of the plurality of electrodes as shown in Examiner’s diagram of Fig. 3 above in which a designated radiopaque section of the struts is circumferentially aligned with a distal-most electrode).
Regarding claim 34, (alternate interpretation – changes made to the location of the designated radiopaque markers) Muessig discloses:
A method of deploying an expandable structure (support member 6) (see Figs. 1 and 3; see also Para. [0047]) within a vessel (see Para. [0012]-[0014] and [0048]) for stimulation of nerves surrounding the vessel (see Para. [0012] and [0047]), the method comprising:
inserting the expandable structure (support member 6) within the vessel to a target location along a length of the vessel (see Para. [0012]-[0014] and [0047]), the expandable structure (support member 6) comprising a plurality of electrodes (electrodes 14) (see Figs. 3-4 and Para. [0057] mentioning a “plurality of electrodes 14”) adapted to be activated to cause stimulation of the nerves surrounding the vessel (see Para. [0012]-[0014], [0047] and [0058]) and a radiopaque marker (see Para. [0030] and [0069]-[0070] mentioning wherein at least one portion of the support members (6), struts (12), tether, or filaments (3) may either include radiopaque markers or be formed from radiopaque material that is visual under x-ray fluoroscopy; for the purposes of examination, the struts (12) are interpreted to comprise the radiopaque markers) positioned so as not to longitudinally overlap with any of the plurality of electrodes on the expandable structure (see Examiner’s Diagram of Fig. 3_ Proximal Electrode below; electrodes (14) are protruding radially-outward from the designated radiopaque struts (12) and thus do not longitudinally overlap therewith), wherein the radiopaque marker comprises a V-shaped marker (see Figs. 3 showing wherein the struts (12) comprise V-Shaped portions; the “turnaround points” along the length of the struts (12) constitute “V-shaped” portions; combined with the radiopaque material used to form the struts, the resulting structure constitutes “V-shaped markers”); and
fully expanding the expandable structure within the vessel (see Para. [0011], [0024]-[0026] and [0047]).
Examiner’s Diagram of Fig. 3_Proximal Electrode
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However, while Muessig discloses wherein x-ray imaging is done to visualize the radiopaque elements of the device during navigation and use (see Para. [0030] and [0069]-[0070] and correct or adjust the position of the device within the target blood vessel lumen depending on the alignment of the one or more radiopaque elements (see Para. [0030]), Muessig does not expressly disclose the steps of:
imaging the expandable structure using an imaging modality adapted to facilitate visualization of radiopaque material;
determining a rotational orientation of the expandable structure based the radiopaque marker prior to fully expanding the expandable structure to contact a wall of the vessel; wherein determining the rotational orientation of the expandable structure comprises determining whether the V-shaped marker is right-side-up or upside-down;
adjusting the rotational orientation of the expandable structure based on the determining the rotational orientation of the expandable structure.
However, since Muessig provides express disclosure of wherein x-ray imaging is done to visualize the radiopaque elements of the device during navigation and use (see Para. [0030] and [0069]-[0070]) and, depending on the orientation of one or more radiopaque markers, a user can determine the orientation of device to correct or adjust the position of the device within the target blood vessel lumen depending on the alignment of the one or more radiopaque elements (see Para. [0030]), it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have performed the steps of:
imaging the expandable structure using an imaging modality adapted to facilitate visualization of radiopaque material (see Para. [0030] and [0069]-[0070] mentioning wherein x-ray imaging is done to visualize the radiopaque elements of the device during navigation and use; during x-ray imaging, a user would be able to visualize the radiopaque material of the radiopaque elements of the device to allow for proper placement within a target vessel as an inherent step in guiding the device to a target location);
determining a rotational orientation of the expandable structure based the radiopaque marker prior to fully expanding the expandable structure to contact a wall of the vessel (see Para. [0030] and [0069]-[0070] mentioning wherein x-ray fluoroscopy is utilized to determine the location and rotational orientation of the device during navigation and implantation; it would have been obvious to one of ordinary skill in the art to have continuously monitored at least one radiopaque element to ensure proper rotational alignment prior to fully expanding the device at a target location to reduce risk of damage to the vessel and/or surrounding nerves);
wherein determining the rotational orientation of the expandable structure comprises determining whether the V-shaped marker is right-side-up or upside-down (see Para. [0030] and [0069]-[0070]; depending on the V-Shaped section of the struts (12) a user is monitoring, the inherent V-shape and orientation of the struts would cause the radiopaque V-Shaped section of the monitored strut section to either be right-side up or upside-down; see Examiner’s Diagram of Fig. 3_Proximal Electrode above pointing to a designated exemplary V-shaped radiopaque strut section that a user may use to orient the device; it would have been obvious to one of ordinary skill in the art, during the navigation phase of the device, to have continuously monitored the location and orientation of the device based on readings from at least one radiopaque element to ensure proper placement within a target vessel);
adjusting the rotational orientation of the expandable structure based on the determining the rotational orientation of the expandable structure (see Para. [0030] and [0069]-[0070] mentioning wherein the location and rotational orientation of the device is continuously monitored under x-ray fluoroscopy during navigation and implantation; one of ordinary skill would ensure proper orientation of the device during navigation as part of the monitoring process to ensure the device is deployed in the proper orientation to reduce the risk of damage to the target location).
Regarding claim 37, (alternate interpretation) Muessig discloses the method of claim 34, Muessig further discloses wherein the radiopaque marker is positioned distal to any of the plurality of electrodes (see Examiner’s Diagram of Fig. 3_Proximal Electrode above showing an electrode positioned proximally of the designated radiopaque section of the strut).
Regarding claim 38, (alternate interpretation) Muessig discloses the method of claim 34, Muessig further discloses wherein the radiopaque marker is circumferentially aligned with at least one of the plurality of electrodes (see Examiner’s Diagram of Fig. 3_Proximal Electrode above showing wherein the labeled electrodes (14) are circumferentially aligned with sections of the struts).
Regarding claim 39, (alternate interpretation) Muessig discloses the method of claim 38, Muessig further discloses wherein the radiopaque marker is circumferentially aligned with a proximal-most electrode of the plurality of electrodes (see Examiner’s Diagram of Fig. 3_Proximal Electrode above showing wherein a designated radiopaque section of the struts is circumferentially aligned with a proximal-most electrode).
Claim(s) 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Muessig (US 2016/0067474 A1)(previously of record) in view of Heraty (US 2011/0257673 A1)(previously of record).
Regarding claim 35, Muessig discloses all of the limitations of the method of claim 34.
However, Muessig does not expressly disclose partially expanding the expandable structure prior to the determining the rotational orientation of the expandable structure.
In the same field of endeavor, namely expandable medical devices comprising a radiopaque feature configured to aid in orientation of said device within a surgical area, Heraty teaches an expandable medical device (see Fig. 2A and Para. [0002]-[0005]) having one or more radiopaque markers disposed along the body of the device (see Para. [0009]-[0010]) such that when the expandable element is inflated, the radiopaque markers become more clearly visible relative to additional reference points under fluoroscopy. (see Para. [0030]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of being obvious to try (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)) to have partially expanded the expanded member of Muessig prior to determining the rotational orientation under fluoroscopy to allow for a better, more clear image of the orientation of the device during the initial stages of expansion, making adjustments to the orientation as needed during subsequent expansion as suggested by the disclosure of Heraty. Since there are only a finite number of possible times to view and check the orientation of the device within a vessel (i.e., when completely unexpanded, partially expanded or fully expanded), it would be a matter of obviousness to one of ordinary skill in the art to have partially expanded the expandable member of Muessig before determining the rotational orientation of the device to have allowed for a more clear image of the device in a target area when the individual strut elements are further apart from one-another, allowing for a more clear view of the relative location of the individual strut elements during the partially-expanded shape.
Claim(s) 41-42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Muessig (US 2016/0067474 A1)(previously of record) in view of Ransbury (US 2013/0072995 A1)(previously of record).
Regarding claim 41, Muessig discloses all of the limitations of the method of claim 34.
However, while Muessig discloses an optional inclusion of a delivery tool (see Para. [0027]), Muessig does not expressly disclose wherein expanding the expandable structure comprises retracting an outer sheath surrounding the expandable structure.
In the same field of endeavor, namely expandable nerve stimulation devices, Ransbury teaches a vascular nerve stimulation devices (see Fig. 5A and 7) comprising an expandable structure (anchor elements 18, see Figs. 5A and 7; see also Para. [0025]) having a plurality of electrodes thereon (electrodes 20 and 34, see Para. [0025]); wherein the expandable structure is delivered through an outer sheath (outer sleeve 36, see Fig. 7 and Para. [0026]) would protects the device from the external vascular environment until at a target site; wherein upon retraction said outer sheeve, the expandable structure self-expands to contact the vessel wall (see Para. [0026]).
Since Muessig discloses a delivery system comprising a delivery sheath but does not provide substantial functional details pertaining to this system, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have looked to the available prior art for similar analogous devices any accompanying delivery sheath system and modified the delivery system of Muessig to comprise the delivery sheath system disclosed by Ransbury comprising a retractable outer sleeve within which the expandable structure is disposed during the navigation and delivery process which would protect the device during navigation through tortuous anatomy such that, upon retraction of the outer sleeve, the expandable structure is able to self-expand to a deployed configuration (see Ransbury Para. [0026]).
Regarding claim 42, Muessig discloses all of the limitations of the method of claim 34, Muessig further discloses wherein the expandable structure comprises an expandable braided structure (see Fig. 4 and Para. [0059] mentioning wherein the expandable structure may comprise flexible woven fabric (17) interconnected between the strut elements).
However, Muessig does not expressly disclose wherein the expandable structure is self-expandable.
In the same field of endeavor, namely expandable nerve stimulation devices, Ransbury teaches a vascular nerve stimulation devices (see Fig. 5A and 7) comprising an expandable structure (anchor elements 18, see Figs. 5A and 7; see also Para. [0025]) having a plurality of electrodes thereon (electrodes 20 and 34, see Para. [0025]); wherein the expandable structure is delivered through an outer sheath (outer sleeve 36, see Fig. 7 and Para. [0026]) would protects the device from the external vascular environment until at a target site; wherein upon retraction said outer sheeve, the expandable structure self-expands to contact the vessel wall (see Para. [0026]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known expansion mechanism for another (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)) to have obtained the predictable result of having the expandable strut structure of Muessig be self-expandable upon release from the disclosed delivery device. While Muessig discloses wherein the expandable structure is dilatable from a compressed state to a radially expanded state via a delivery tool (see Para. [0011], [0026]-[0027]), Muessig does not provide substantial structural or functional disclosure pertaining to how the delivery tool operates to radially expand the expandable member. In seeking to provide a known means from analogous art to accomplish the disclosed expansion operation, it would have been obvious to one of ordinary skill to have looked to the prior art for similar devices to be utilized in the expansion system of Muessig. Upon incorporation of the expansion system of Ransbury into the device of Muessig, one of ordinary skill in the art would have expected the expandable member to function appropriately should the expandable member be expanded via self-expanding strut elements upon retraction of an outer delivery sleeve, as disclosed by Ransbury.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's
disclosure. See the attached PTO-892 Notice of References Cited. Specifically, US 2020/0187805 A1 to Purcell, US 12599339 B2 to Waldhauser, US 11986650 B2 to Machado and US 10632304 B2 to Muessig all disclose neural stimulation devices comprising an expandable structure having at least one stimulating electrode disposed thereon.
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 MITCHELL B HOAG whose telephone number is (571)272-0983. The examiner can normally be reached 7:30 - 5:00 M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 5712724695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.B.H./Examiner, Art Unit 3771
/Andrew Restaino/Primary Examiner, Art Unit 3771
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