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 August 14, 2026 have been fully considered but they are not persuasive.
In response to applicant’s argument that Bjerken does not disclose a cinching mechanism that moves the two rings towards one another, Bjerken discloses that the tension on sutures 515 provide upward force on the distal ring in order to fasten the distal ring to the proximal ring (paragraph 0103-0106) and thereby ‘cinching’ the two rings towards one another, a cinching mechanism is also described in paragraphs 0086-0088 of Bjerken Ser No 11327348, incorporated by reference. Furthermore, it is noted that this limitation is a functional limitation. The two termini 220 of the cord can by cinched and tensioned via pulling on magnetic member 215, and since the cord is threaded through the proximal and distal rings as shown in figure 10, the device of Bjerken would be capable of moving the proximal ring and the distal ring towards one another when the cord is tightened by concurrently pulling them in a proximal direction away from the proximal face of the proximal ring. As long as the device is capable of performing the recited functions, the prior art meets the limitations. Therefore, applicant’s arguments are not persuasive.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 6-8, 11, 14-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bjerken (US 20080027473).
Regarding claim 1, Bjerken discloses a cinch ring system for providing a shunt or a plug within the body of a patient, comprising: a proximal ring (110) comprising a proximal face, a distal face, and a plurality of stitch holes (109); a distal ring (105) comprising a proximal face, a distal face, and a plurality of stitch holes (107); and a cord (115) that is stitched along and between the proximal ring and the distal ring via the plurality of stitch holes of the proximal and distal rings, wherein each of the two termini (220) of the cord extend out from the proximal face of the proximal ring via a stitch hole of the proximal ring; and wherein the system has a cinching mechanism capability that moves the proximal ring and the distal ring towards one another when the cord is tightened by concurrently pulling the two termini of the cord in a proximal direction away from the proximal face of the proximal ring (figure 10; the tension on sutures 515 provide upward force on the distal ring in order to fasten the distal ring to the proximal ring (paragraph 0103-0106) and thereby ‘cinching’ the two rings towards one another, a cinching mechanism is also described in paragraphs 0086-0088 of Bjerken Ser No 11327348, incorporated by reference. Furthermore, it is noted that this limitation is a functional limitation. The two termini 220 of the cord can by cinched and tensioned via pulling on magnetic member 215, and since the cord is threaded through the proximal and distal rings as shown in figures 12A-12B, the device of Bjerken would be capable of moving the proximal ring and the distal ring towards one another when the cord is tightened by concurrently pulling them in a proximal direction away from the proximal face of the proximal ring. As long as the device is capable of performing the recited functions, the prior art meets the limitations).
Regarding claim 6, Bjerken discloses all of the limitations set forth in claim 1, wherein the proximal ring and the distal ring are each capable of being sheathed within a transcatheter (640) capable of delivery via the circulatory system (paragraph 0061, ring diameter is 10-15mm, and therefore can be delivered into the circulatory system, it is noted functional limitations are not given full patentable weight. As long as the prior art meets the structural requirements and is capable of performing the recited function, the prior art meets the limitations).
Regarding claim 7, Bjerken discloses all of the limitations set forth in claim 1, wherein the proximal ring and the distal ring are each composed of a biocompatible and malleable material (paragraph 0060, 0072, 0087, 0101).
Regarding claim 8, Bjerken discloses a cinch ring system for providing a shunt or a plug within the body of a patient, comprising: a proximal ring (110) comprising a proximal face, a distal face, and a plurality of stitch holes (109); a distal ring (105) comprising a proximal face, a distal face, and a plurality of stitch holes (107); and a cord (115) that is stitched along and between the proximal ring and the distal ring via the plurality of stitch holes of the proximal and distal rings, wherein each of the two termini (220) of the cord extend out from the proximal face of the proximal ring via a stitch hole of the proximal ring; and wherein the system has a cinching mechanism capability that moves the proximal ring and the distal ring towards one another when the cord is tightened by concurrently pulling the two termini of the cord in a proximal direction away from the proximal face of the proximal ring (figure 10), wherein a cover (125) spans the central aperture of at least one ring of the proximal ring and the distal ring (figure 3).
Regarding claim 11, Bjerken discloses all of the limitations set forth in claim 10, wherein the through hole or slit is sealable (a plug can be placed within aperture 123, and thus it is ‘sealable’).
Regarding claim 14, Bjerken discloses all of the limitations set forth in claim 8, wherein the proximal ring and the distal ring are each capable of being sheathed within a transcatheter(640) capable of delivery via the circulatory system (paragraph 0061, ring diameter is 10-15mm, and therefore can be delivered into the circulatory system, it is noted functional limitations are not given full patentable weight. As long as the prior art meets the structural requirements and is capable of performing the recited function, the prior art meets the limitations).
Regarding claim 15, Bjerken discloses all of the limitations set forth in claim 8, wherein the proximal ring and the distal ring are each composed of a biocompatible and malleable material (paragraph 0060, 0072, 0087, 0101).
Regarding claim 16, Bjerken discloses a delivery system for delivering a cinch ring system to a target site within the body of a patient, comprising: a catheter comprising an outer sheath (640) and an inner sheath (615); and a cinch ring system comprising: a proximal ring (110) comprising a proximal face, a distal face, and a plurality of stitch holes (109); a distal ring (105) comprising a proximal face, a distal face, and a plurality of stitch holes (107); and a cord (115) that is stitched along and between the proximal ring and the distal ring via the plurality of stitch holes of the proximal and distal rings; wherein the cinch ring system has a cinching mechanism (115, 125, 607); wherein the cinch ring system is contained within the outer sheath and is in connection with the inner sheath of the catheter (figure 20A-23).
Regarding claim 17, Bjerken discloses all of the limitations set forth in claim 16, wherein the cinch ring system is in connection with the inner sheath via a set of one or more release wires (615).
Regarding claim 18, Bjerken discloses all of the limitations set forth in claim 17, wherein the set of one or more release wires comprises at least three release wires, wherein each release wire provides an attachment point to connect the cinch ring system with the inner sheath (figure 20A-23).
Regarding claim 19, Bjerken discloses all of the limitations set forth in claim 18, wherein a first release wire provides a first attachment to the distal ring, wherein a second release wire provides an attachment to the proximal ring, and wherein a third release wire provides a second attachment to the distal ring (Figures 20A-20B, multiple release wires attach at multiple attachments of each of the first and second ring).
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.
Claims 2 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Bjerken (US 20080027473) as applied to claims 1 and 8 above, and further in view of Kagan et al (US 20040092892).
Regarding claims 2 and 12, Bjerken discloses all of the limitations set forth in claims 1 and 8, but does not disclose the proximal ring or the distal ring contain at least one radiopaque marker. Kagan et al (hereafter Kagan) teaches a ring system for delivery into the human body, wherein it was known in the art at the time to make the device out of radiopaque materials for enhanced imaging by x-ray, fluoroscopy and/or ultrasonic imaging so that the position and functional state of the implanted device can be verified non-invasively. Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to make the proximal or distal ring contain at least one radiopaque marker, as taught by Kagan, in order to allow enhanced imaging by x-ray, fluoroscopy and/or ultrasonic imaging so that the position and functional state of the implanted device can be verified non-invasively.
Regarding claim 5, Bjerken discloses all of the limitations set forth in claim 1, but does not disclose at least one ring of the proximal ring and the distal ring incorporates a sensor. However, Kagan teaches a ring system for delivery into the stomach for reducing stomach volume, wherein the device comprises a sensor for sensing water or certain nutrients or activity related to ingestion such as swallowing or gastric response (paragraph 0236). Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to include a sensor, as taught by Kagan, on at least one ring of the proximal or distal ring in order to sense water or certain nutrients or activity related to ingestion, such as swallowing or gastric response to adjust the volume of the effective area of the created orifice accordingly.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Bjerken (US 20080027473) as applied to claims 1 and 8 above, and further in view of Willis et al (US 6811555).
Regarding claims 3 and 13, Bjerken discloses all of the limitations set forth in claims 1 and 8, wherein the rings can be a variety of shapes (paragraph 0059), but does not disclose least one ring of the proximal ring and the distal rings comprises a set of one or more protrusions extending outwardly from the ring. Willis et al (hereafter Willis) teaches a proximal and distal ring to be coupled together on opposite sides of tissue, wherein the rings comprise a set of one or more protrusions (50, 52) extending outwardly from the ring (figure 6) acting as docking arms to align the rings with one another and attaching together the two aligned rings. Therefore, it would have been within the level of one with ordinary skill in the art at the time of the invention to include a set of one or more protrusions extending outwardly from the ring to act as docking arms, as taught by Willis, in order to align the rings with one another, since it has been held that a mere change in shape is within the level of ordinary skill in the art and it appears that the specification discloses that the device would perform equally well with either designs.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Bjerken (US 20080027473) as applied to claim 1 above, and further in view of Argentine (US 20140276976).
Regarding claim 4, Bjerken discloses all of the limitations set forth in claim 1, but does not disclose at least one stitch hole of the proximal ring or the distal ring incorporates a cord grip. Argentine discloses a suturing device comprising a stitch hole (355) incorporating a cord grip (339) to grip and secure the ends of the cord disposed therein. Therefore, it would have been within the level of one with ordinary skill in the art to include a cord grip into the at least one stitch hole of the proximal or distal ring, as taught as known in the art at the time of the invention for suture holes by Argentine, in order to secure the ends of the cord.
Allowable Subject Matter
Claims 9, 10, and 20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The prior art teaches all of the limitations set forth in claim 16, however, no reference could be found that teaches a cover spans the central aperture of each ring of the proximal ring and the distal ring, wherein each cover incorporates a through hole or slit, and wherein the inner sheath traverses through each through hole or slit that can be combined with the limitations set forth in claim 16. Therefore, the claims have not been rejected over the body of prior art since there is no teaching, suggestion, or motivation to produce the claimed invention.
Conclusion
THIS ACTION IS MADE FINAL. 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 ANH TIEU DANG whose telephone number is (571)270-3221. The examiner can normally be reached Monday-Thursday (9am-4pm EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANH T DANG/Primary Examiner, Art Unit 3771
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