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 responsive to the amendment filed on 11/26/25. As directed by the amendment: claims 5 and 11 have been amended, claims 13-21 have been cancelled, and new claims 22-30 have been added. Thus, claims 1-12 and 22-30 are presently pending in this application.
The amendments to claim 11 are sufficient to overcome the rejection under 35 U.S.C. 112(b) from the prior action.
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.
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cook et al. (US 20100292530; hereinafter “Cook ‘530”) in view of van der Burg et al. (US 20040230222; hereinafter “Burg”).
Regarding claim 1, Cook ‘530 discloses an implantable device 132 (fig. 13) configured to be positioned in tissue of a living body for coaptation of a body lumen of the living body (par. 0032 describes the general concept, of which fig. 13 is one embodiment), the implantable device comprising: an adjustable membrane element 10 configured to coapt the body lumen (fully capable of performing this function; see par. 0032) and including a continuous wall (see fig. 13) having an inner surface (inner surface of wall of 10) defining a chamber (interior of 10); an elongate conduit 11 including a conduit peripheral surface (outer surface of 11), a conduit rear end (not illustrated specifically in the fig. 13 embodiment, but illustrated more generally in, for example, fig. 1A-C as 12), a conduit front end (end from which 130 protrude, fig. 13), and one or more conduit lumens (124 and 126), the conduit peripheral surface connected to and sealed to the adjustable membrane element at or near the conduit front end (see fig. 13), the one or more conduit lumens including at least an inflation lumen 126 having a first opening at the conduit rear end (rearmost end of 126), a second opening in fluid communication with the chamber (unlabeled opening between 126 and interior of 10 visible in fig. 13), and a closed end at or near the conduit front end (126 ends, longitudinally, at the point where it branches to meet the interior of 10, forming a closed end past that point; fig. 13); a rear port connected to the elongate conduit at the conduit rear end and including a cavity in fluid communication with the first opening of the inflation lumen (port with septum formed by 12; see fig. 1A-C and par. 0033); and an anchoring mechanism 130 coupled to the conduit front end and configured to anchor the implantable device to the tissue (fig. 13; par. 0044), except for specifically disclosing a helix coupled to the conduit front end and configured to anchor to the tissue by rotating the entire implantable device in a tightening direction. However, Burg teaches utilizing a distal anchoring mechanism in the form of a helical anchor attached to a distal end of the device and anchorable by rotating the device (see fig. 16; par. 0076). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the Cook ‘530 anchoring mechanism to utilize a distally positioned helical anchor, as taught by Burg, since such a modification is a simple substitution of one known anchoring mechanism (helical anchor) for another (barbed anchor) to achieve a predictable result (anchoring the distal end of the device upon implantation; Burg par. 0076), notably while avoiding the potential problem with lateral hook anchors potentially puncturing laterally positioned tissue, identified by Cook ‘530 (par. 0044), by anchoring in a directly distal position (see fig. 16 of Burg).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cook ’530 in view of Burg, and further in view of Cook et al. (US 20200261200; hereinafter “Cook ‘200”).
Regarding claim 2, Cook ‘530, in view of Burg, fails to disclose or teach the rear port comprises a strain relief and a port base coupled to the strain relief and is connected to the elongate conduit with the conduit rear end in the strain relief. However, Cook ‘200 teaches, in a similar device (see fig. 10), a rear port 1016 comprising a strain relief (conical portion of 1016) and a port base (proximal cylindrical portion of 1016) and a conduit rear end connected within the strain relief (rear end of 1014 as illustrated in fig. 10 terminates inside the conical section). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to connect the port and conduit of Cook ‘530 in this way, as taught by Cook ‘200, since the port and conduit of Cook ‘530 necessitate connection while Cook ‘530 is silent to the exact mechanism for such, while Cook ‘200 discloses a mechanism that will specifically accomplish connection between the elements required by Cook ‘530.
Claim(s) 3, 22, and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cook ‘530 in view of Burg and Cook ‘200, and further in view of Gillespie, Jr. et al. (US 20100222802; hereinafter “Gillespie”).
Regarding claim 3, Cook ‘530, in view of Burg, fails to disclose or teach one or more elastic portions each constructed of biostable segmented polyurethane. However, Cook ‘200 teaches utilizing biocompatible polyurethane elastomer for all or part of a similar device (par. 0039, 0053). Gillespie further teaches utilizing, in particular, segmented polyurethane with good biodurability properties (par. 0499-0500) for an implantable device. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the Cook ‘530 device to utilize biostable segmented polyurethane, as taught in combination by Cook ‘200 and Gillespie, in order to impart desirable material properties to the implanted device.
Regarding claim 22, Cook ‘200 further teaches, in a similar device (see fig. 10), the rear port 1016 comprises an elastic septum 1018 (par. 0060) constructed of polyurethane (par. 0053) and configured to allow access to the cavity using a hollow needle (par. 0060), except for specifically disclosing biostable segmented polyurethane. Gillespie further teaches utilizing, in particular, segmented polyurethane with good biodurability properties (par. 0499-0500) for an implantable device. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the Cook ‘530 device to utilize biostable segmented polyurethane, as taught in combination by Cook ‘200 and Gillespie, in order to impart desirable material properties to the implanted device.
Regarding claim 23, Cook ‘200 teaches, in a similar device (see fig. 10), a rear port 1016 comprising a strain relief (conical portion of 1016) and a port base (proximal cylindrical portion of 1016) and a conduit rear end connected within the strain relief (rear end of 1014 as illustrated in fig. 10 terminates inside the conical section). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to connect the port and conduit of Cook ‘530 in this way, as taught by Cook ‘200, since the port and conduit of Cook ‘530 necessitate connection while Cook ‘530 is silent to the exact mechanism for such, while Cook ‘200 discloses a mechanism that will specifically accomplish connection between the elements required by Cook ‘530. Furthermore, Cook ‘200 teaches utilizing biocompatible polyurethane elastomer for all or part of a similar device (par. 0039, 0053). Gillespie further teaches utilizing, in particular, segmented polyurethane with good biodurability properties (par. 0499-0500) for an implantable device. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the Cook ‘530 device to utilize biostable segmented polyurethane, as taught in combination by Cook ‘200 and Gillespie, in order to impart desirable material properties to the implanted device.
Claim(s) 4 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cook ‘530 in view of Burg, and further in view of Corradi et al. (US 20050267478).
Regarding claims 4 and 24, Cook ‘530, in view of Burg, fails to disclose or teach the helix constructed of a bioresorbable material, comprising a bioresorbable polymer. Hoewever, Corradi et al. teaches constructing a helical anchor from bioresorbable material (abstract) and specifically a polymer (par. 0079). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the helical anchor of Cook ‘530, as modified by Burg, to be constructed of bioresorbable material, for the purpose of allowing the device to be easily removed after a period of time.
Claim(s) 5-9, 11, 27, and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burton et al. (US 6419624) in view of Cook ‘530 and Burg.
Regarding claim 5, Burton discloses an implantable device kit for controllable coaptation of a body lumen in tissue of a target site in a living body (kit of fig. 16A-D, with reference to fig. 5 for general characteristics not illustrated in fig. 16A-D and to specific sheath embodiment of fig. 11), comprising: an implantable device 1640 including: an adjustable membrane element 1644 configured to coapt the body lumen (fully capable of performing this function; abstract) and including a continuous wall (wall or 1644) having an inner surface (inner surface of wall of 1644) defining a chamber (chamber within 1644); an elongate conduit 1648 including a conduit peripheral surface (outer surface of 1648), a conduit rear end (rear end of 1648 at 1654), a conduit front end (end of 1648 within 1644), and one or more conduit lumens (interior inflation lumen, 510 fig. 5), the conduit peripheral surface connected to and sealed to the adjustable membrane element at or near the conduit front end (see fig. 5), the one or more conduit lumens including an inflation lumen having a first opening at the conduit rear end (512 in fig. 5), a second opening in fluid communication with the chamber (520 in fig. 5), and a closed end at or near the conduit front end (end of 510 distal to 520 is closed; see fig. 5); a rear port 530 connected to the conduit rear end and including a cavity 536 in fluid communication with the first opening of the inflation lumen (see fig. 5); and a sheath 1604 configured to accommodate portions of the implantable device including the adjustable membrane element, to guide the implantable device to the target site, and to be used to rotate the implantable device when the portions of the implantable device is placed in the sheath with the adjustable membrane element partially inflated (structure of sheath 1604 in fig. 16A-D is fully capable of performing each function, see structure illustrated in fig. 16A-D), except for disclosing a helix coupled to the conduit front end and configured to anchor the implantable device to the tissue by rotating the entire implantable device in a tightening direction. However, Cook ‘530 teaches utilizing an anchoring mechanism 130 at the distal end of a similar implantable device (fig 13). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Burton et al. to utilize a distal anchoring mechanism, as taught by Cook ‘530, for the purpose of providing sufficient structure to hold the device in the desired implanted location (par. 0044). Furthermore, Burg teaches utilizing a distal anchoring mechanism in the form of a helical anchor attached to a distal end of the device and anchorable by rotating the device (see fig. 16; par. 0076). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the Burton et al. in view of Cook ‘530 anchoring mechanism to utilize a distally positioned helical anchor, as taught by Burg, since such a modification is a simple substitution of one known anchoring mechanism (helical anchor) for another (barbed anchor) to achieve a predictable result (anchoring the distal end of the device upon implantation; Burg par. 0076), notably while avoiding the potential problem with lateral hook anchors potentially puncturing laterally positioned tissue, identified by Cook ‘530 (par. 0044), by anchoring in a directly distal position (see fig. 16 of Burg).
Regarding claim 6, Burton et al. discloses a push wire 350 (fig. 3), and wherein the one or more conduit lumens further include a push wire lumen 332 having an opening on the elongate conduit to allow the push wire to enter the push wire lumen and a closed end at or near the conduit front end to allow the implantable device to be pushed forward through the sheath by applying a forwarding force to the push wire (see fig. 3).
Regarding claim 7, Burton et al. discloses the sheath comprises: an elongated body (body of 1604) including a sheath rear portion (to the left of fig. 16A), a sheath front portion (to the right of fig. 16A), and a sheath middle portion coupled between the sheath rear portion and the sheath front portion (see fig. 16A); and a longitudinal slot 1638 including at least a slot middle portion extending on the sheath middle portion and a slot front portion extending on the sheath front portion (slot has the same portions as the sheath, see fig. 16A), the slot middle portion configured to allow placement of the portions of the implantable device in the sheath (see fig. 16A), the slot front portion configured to allow the implanted device to rotate with the sheath when the adjustable membrane element is placed substantially in the sheath and partially inflated and to allow the sheath to be separated from the implantable device (structure of fig. 16A-D fully capable of performing this function).
Regarding claims 8 and 9, Burton et al. discloses the sheath front portion comprises an interior surface including one or more gripping features in the forms of ridges (ridges formed at 1034, fig. 11).
Regarding claim 11, Burton et al. discloses the sheath comprises an interior surface 1612 and an exterior surface 1616, the longitudinal slot is formed by two slot edges each coupled between the interior surface and the exterior surface (edges of 1634, see fig. 16B), the two slot edges each comprise an inner edge directly coupled to the interior surface and an outer edge directly coupled to the exterior surface (inner and outer edges of 1634 in fig. 16B). Burton et al. also teaches utilizing, in the alternative, either the same angle for the inner/outer edge (fig. 16B), a larger angle for the inner edge than the outer edge (see 1038 in fig. 11) or a smaller angle for the inner edge than the outer edge (see 832 in fig. 8B), but fails to specifically teach or disclose that the edges are rounded edges with a radius. However, utilizing a round shaped edge vs. an angle shaped edge is the result of a mere change in shape that is considered is a matter design choice which a person of ordinary skill in the art before the effective filing date of the claimed invention would have found obvious and is also considered obvious to try between known edge shapes (curved vs. angled), and choice between relative radii sizes of the two edges would be obvious to try between similar arrangements to those disclosed by Burton et al. in the three cited edge embodiments.
Regarding claim 27, Burton et al. discloses the sheath comprises: an elongated body (body of 1604) including a sheath rear portion (to the left of fig. 16A), a sheath front portion (to the right of fig. 16A), and a sheath middle portion coupled between the sheath rear portion and the sheath front portion (see fig. 16A); and a longitudinal slot 1638 including at least a slot middle portion extending on the sheath middle portion and a slot front portion extending on the sheath front portion (slot has the same portions as the sheath, see fig. 16A), the slot middle portion wider than the slot front portion (when configured as an embodiment which includes a receptacle region 1244 as illustrated in fig. 12B).
Regarding claim 28, Burton et al. discloses the conduit is configured to be stretched to have a diameter smaller than a width of the slot front portion to allow the sheath to be separated from the implantable device by passing the stretched conduit through the slot front portion after the adjustable membrane element is placed substantially in the sheath (when configured according to the embodiment described in col. 11, ln. 38-43, the conduit is fully capable of performing this claimed function).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burton et al. in view of Cook ‘530 and Burg, and further in view of Cook ‘200.
Regarding claim 10, Burton et al. discloses the rear port 530 comprises a strain relief (tapered portion of 530 that connects to the conduit, fig. 5) and a port base coupled to the strain relief (proximal cylindrical portion of 530, fig. 5) and is connected to the elongate conduit (see fig. 5), at least a portion of the strain relief configured for passing the slot front portion of the sheath when the sheath is separated from the implantable device (at least the tapered portion is fully capable of performing this function), except for disclosing the conduit rear end in the strain relief. However, Cook ‘200 teaches, in a similar device (see fig. 10), a rear port 1016 comprising a strain relief (conical portion of 1016) and a port base (proximal cylindrical portion of 1016) and a conduit rear end connected within the strain relief (rear end of 1014 as illustrated in fig. 10 terminates inside the conical section). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to connect the port and conduit of Burton et al. in this way, as taught by Cook ‘200, since the port and conduit of Burton et al. necessitate connection, and Cook ‘200 discloses a mechanism that will specifically accomplish connection between the elements required by Burton et al.
Claim(s) 12, 29, and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burton et al. in view of Cook ‘530 and Burg, and further in view of Cook ‘200 and Gillespie.
Regarding claim 12, Burton et al., in view of Cook ‘530 and Burg, fails to disclose or teach one or more elastic portions each constructed of biostable segmented polyurethane. However, Cook ‘200 teaches utilizing biocompatible polyurethane elastomer for all or part of a similar device (par. 0039, 0053). Gillespie further teaches utilizing, in particular, segmented polyurethane with good biodurability properties (par. 0499-0500) for an implantable device. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the Burton et al. device to utilize biostable segmented polyurethane, as taught in combination by Cook ‘200 and Gillespie, in order to impart desirable material properties to the implanted device.
Regarding claims 29 and 30, Cook ‘200 teaches, in a similar device (see fig. 10), the strain relief is a conical strain relief (conical portion of 1016), and the rear port 1016 comprises an elastic septum 1018 (par. 0060) constructed of polyurethane (par. 0053) and configured to allow access to the cavity using a hollow needle (par. 0060), except for specifically disclosing biostable segmented polyurethane for the strain relief or septum. Gillespie further teaches utilizing, in particular, segmented polyurethane with good biodurability properties (par. 0499-0500) for an implantable device. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the Cook ‘530 device to utilize biostable segmented polyurethane for the strain relief or the septum, as taught in combination by Cook ‘200 and Gillespie, in order to impart desirable material properties to the implanted device.
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cook ‘530 in view of Burg, and Corradi et al., and further in view of Shinar et al. (US 20150148837).
Regarding claim 25, Corradi et al. fails to specifically teach the bioresorbable material comprises a bioresorbable metal. However, Shinar et al. teaches utilizing bioresorbable materials in the form of bioresorbable metal (par. 0125). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize either a bioresorbable polymer or a bioresorbable metal, since both materials are acceptable biocompatible options for a bioresorbable material.
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burton et al. in view of Cook ‘530 and Burg, and further in view of Corradi et al.
Regarding claim 26, Burton et al. in view of Cook ‘530 and Burg fails to disclose or teach the helix constructed of a bioresorbable material. Hoewever, Corradi et al. teaches constructing a helical anchor from bioresorbable material (abstract). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the helical anchor of Burton et al. in view of Cook ‘530 and Burg, to be constructed of bioresorbable material as taught by Corradi et al., for the purpose of allowing the device to be easily removed after a period of time.
Response to Arguments
Applicant's arguments filed 11/26/25 have been fully considered but they are not persuasive.
Regarding Applicant’s arguments in the Remarks that Burg does not disclose rotating the entire implantable device in a tightening direction, examiner notes that this limitation is functional in nature, and that the device of Burg is fully capable of being rotated in its entirety, with all elements rotated together, to insert the anchor as claimed.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN R PRICE whose telephone number is (571)270-5421. The examiner can normally be reached Mon-Fri 8:00am-4:00pm Eastern time.
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, Michael Tsai can be reached at 571-270-5246. 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.
/NATHAN R PRICE/Primary Examiner, Art Unit 3783