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. Claim Rejections - 35 USC § 102 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 16-19, 25 -28 , 30, and 33-35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wu et al. (US 20110172692 A1) . R egarding claim 16 , Wu discloses a n endoprosthesis that is adjustable in diameter between both larger and smaller diametric setpoints ( ¶ 0072 and ¶ 0074 disclose a endoprosthesis that is adjustable in diameter between larger and smaller setpoints 46/47/48 ) , the endoprosthesis comprising: a tubular implant (artificial vessel 18) having an implant diameter and an implant length, a first end portion, a mid-portion, and a second end portion along the implant length (see fig. 8a annotated below) ; an adjustment mechanism coupled to the tubular implant (fig. 8a illustrates an adjustment mechanism 10g coupled to the tubular implant 18) , the adjustment mechanism including, a tubular biasing element defining a longitudinal axis, the tubular biasing element coupled to the tubular implant along the implant length ( fig. 8a annotated below illustrates a tubular biasing element 10g defining a longitudinal axis and coupled to the implant along its length ) , the tubular biasing element operable to be enlargeable and reducible between a plurality of diametric setpoints via application of a diametric force to increase and decrease the implant diameter (figs. 8h-8j illustrate and ¶ 0074 discloses a tubular biasing element 10g capabl e of being enlarged or reduced between a plurality of set points 46/47/48. Figs. 8b-8g illustrate and ¶ 0074 discloses the biasing element moving between setpoints due to a diametric force /recoil to increase and decrease the implant diameter ) , the plurality of diametric setpoints including a first diametric setpoint, a second diametric setpoint that is larger than the first diametric setpoint, and a third diametric setpoint that is larger than the second diametric setpoint (figs. 8h-8j illustrate a first diametric set point 48, a second diametric setpoint 47 larger than the first, and a third diametric 46 setpoint larger than the second) . Regarding claim 17 , Wu discloses the invention as claimed as discussed with respect to claim 16. Wu further discloses that the adjustment mechanism is coextensive with the mid-portion of the tubular implant such that the adjustment mechanism is operable to adjust the implant diameter at the mid-portion of the tubular implant ( fig. 8a illustrates the adjustment mechanism 10g coupled to the mid-portion of the implant 18 and ¶ 0072 - ¶ 0073 disclose that the adjustment mechanism 10g discloses that as the adjustment mechanism moves to a smaller setpoints, e.g. from 46 to 47 or from 47 to 48, the diameter of the implant decreases ) . Regarding claim 18 , Wu discloses the invention as claimed as discussed with respect to claim 17. Wu further discloses that tubular the implant takes on an hourglass shape when the tubular biasing element is at the first diametric setpoint (fig. 8a illustrates the adjustment mechanism 10g coupled to the mid-portion of the implant 18 and ¶ 0072 - ¶ 0073 disclose that the adjustment mechanism 10g discloses that as the adjustment mechanism moves to a smaller setpoints, e.g. from 46 to 47 or from 47 to 48, and that the pressure on the adjustment mechanism 10g decreases the inside diameter of the implant 18 i.e. hourglass shape similar to figs. 4b-c ) . Regarding claim 19 , Wu discloses the invention as claimed as discussed with respect to claim 18 . Wu further discloses that the tubular biasing element has a circumferentially wrapped configuration such that the tubular biasing element defines an overlapping region (see 10g in fig. 8a and the overlapping region/extension plate 44/46 in figs. 8h-8j) . Regarding claim 25, Wu discloses a n endoprosthesis that is adjustable in diameter between both larger and smaller diametric setpoints (¶ 0072 and ¶ 0074 disclose a endoprosthesis that is adjustable in diameter between larger and smaller setpoints 46/47/48) , the endoprosthesis comprising: a tubular implant having an implant diameter and an implant length, a first end portion, a mid-portion, and a second end portion along the implant length (see fig. 8a annotated above) ; an adjustment mechanism coupled to the tubular implant (fig. 8a illustrates an adjustment mechanism 10g coupled to the tubular implant 18) , the adjustment mechanism including, a tubular biasing element having a biasing force that may be overcome by application of a diametric force to the tubular biasing element ( ¶ 0073 discloses that a tooth 38 holds/forces/ biases an adjustment mechanism 10g in a first position and when that hold/force is overcome by a diametric force/pressure change the mechanism changes diameter – see figs. 8h-8j ) , the tubular biasing element defining a longitudinal axis, the tubular biasing element coupled to the tubular implant along the implant length (fig. 8a annotated above illustrates a tubular biasing element 10g defining a longitudinal axis and coupled to the implant along its length) , the tubular biasing element operable to be enlargeable and reducible between a plurality of diametric setpoints via application of the diametric force to both increase and decrease the implant diameter (figs. 8h-8j illustrate and ¶ 0074 discloses a tubular biasing element 10g capable of being enlarged or reduced between a plurality of set points 46/47/48. Figs. 8b-8g illustrate and ¶ 0074 discloses the biasing element moving between setpoints due to a diametric force/recoil to increase and decrease the implant diameter) , the plurality of diametric setpoints including a first diametric setpoint, a second diametric setpoint that is larger than the first diametric setpoint, and a third diametric setpoint that is larger than the second diametric setpoint (figs. 8h-8j illustrate a first diametric set point 48, a second diametric setpoint 47 larger than the first, and a third diametric 46 setpoint larger than the second) . Regarding claim 26, Wu discloses the invention as claimed as discussed with respect to claim 25. Wu further discloses that the adjustment mechanism is coextensive with the mid-portion of the tubular implant such that the adjustment mechanism is operable to adjust the implant diameter at the mid-portion of the tubular implant ( ¶ 0074 discloses and figs. 8h-j illustrate that the adjustment mechanism’s 10g movement from setpoints 46 to 47 to 48 decrease the diameter of the tubular implant 18 and ¶ 0074 discloses that the adjustment mechanism’s 10g movement from setpoint 48 to 47 is capable of increasing the tubular implants diameter ). Regarding claim 27, Wu discloses the invention as claimed as discussed with respect to claim 26. Wu further discloses that the tubular implant takes on an hourglass shape (see fig s. 4a-4c and 8a ). The endoprosthesis (18) of Wu may be reduced in diameter at a mid-portion to take on an hour-glass shape when a tubular biasing element is at a first diametric setpoint due to Wu’s adjustment mechanism (10g) comprising a plurality of setpoints in which the first (48) is smaller than subsequent diametric setpoints. Regarding claim 28, Wu discloses the invention as claimed as discussed with respect to claim 27. Wu further discloses that the tubular biasing element has a circumferentially wrapped configuration such that the tubular biasing element defines an overlapping region ( fig. 8a illustrates a tubular biasing element 32 with a circumferentially wrapped configuration and defining an overlapped region as can be seen in fig. 8b – overlapping elements 34, 42, and 44 ). Regarding claim 30, Wu discloses a method comprising: imparting a diametric force onto an endoprosthesis (Figs. 4a-4c, 7A-7E ) , the endoprosthesis including, a tubular implant (18) having an implant diameter (see fig. 8a annotated above) , and an adjustment mechanism (10g) coupled to the tubular implant (fig. 8a illustrates an adjustment mechanism 10g coupled to the tubular implant 18) , the adjustment mechanism including a tubular biasing element operable to be enlargeable and reducible between a plurality of diametric setpoints via application of the diametric force to increase and decrease the implant diameter (figs. 8h-8j illustrate and ¶ 0074 discloses a tubular biasing element 10g capable of being enlarged or reduced between a plurality of set points 46/47/48. Figs. 8b-8g illustrate and ¶ 0074 discloses the biasing element moving between setpoints due to a diametric force/recoil to increase and decrease the implant diameter) , the plurality of diametric setpoints including a first diametric setpoint, a second diametric setpoint that is larger than the first diametric setpoint, and a third diametric setpoint that is larger than the second diametric setpoint (figs. 8h-8j illustrate a first diametric set point 48, a second diametric setpoint 47 larger than the first, and a third diametric 46 setpoint larger than the second). Regarding claim 33, Wu discloses the invention as claimed as discussed with respect to claim 30. Wu further discloses wherein the tubular implant includes a tubular length having a mid-point, the method further including coupling the adjustment mechanism at the mid-point of the tubular implant (see fig. 8a annotated below) . Regarding claim 34, Wu discloses the invention as claimed as discussed with respect to claim 30. Wu further discloses circumferentially wrapping the tubular biasing element about a portion of the tubular implant (fig. 8a illustrates circumferentially wrapping the biasing element 10g about the mid-portion of the tubular implant) . Regarding claim 35, Wu discloses the invention as claimed as discussed with respect to claim 30. Wu further disclose s that the adjustment mechanism has a biasing force, and wherein the diametric force overcomes the biasing force to enlarge and reduce the tubular biasing element (¶ 0073 discloses that a tooth 38 holds/forces/biases an adjustment mechanism 10g in a first position and when that hold/force is overcome by a diametric force/pressure change the mechanism changes diameter – see figs. 8h-8j) . Claim Rejections - 35 USC § 103 The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. Claims 20 - 2 4, 29, and 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over Wu ( US 20110172692 A1 ), in view of Lock et al. (WO 2012018779 A2). Regarding claim 20, Wu discloses the invention as claimed as discussed with respect to claim 16. Wu fails to disclose that the adjustment mechanism further includes a track and rider, the rider configured to translate along the track in response to the diametric force, wherein movement of the rider along the track changes the diameter of the tubular biasing element, wherein the rider is operable to both increase and decrease the diameter of the tubular biasing element upon application of the diametric force, the diametric force including at least one of a mechanical force and a magnetic force . Lock also discloses an endoprosthesis (11) that is adjustable in diameter (see Abstract) the endoprosthesis comprising: an implant having an implant diameter ( see figs. 4-5); an adjustment mechanism coupled to the implant (figs. 4-5 illustrate an adjustment mechanism 50 coupled to the implant 11), the adjustment mechanism including, a tubular biasing element coupled to the implant (figs. 4-5 illustrate an adjustment mechanism 50 comprising a tubular biasing element formed of elements 60/70, that are coupled to the implant 11). Lock teaches the adjustment mechanism (50 , fig. 11 ) includes a track ( 72 ) and a rider ( 60 ), the rider configured to translate along the track in response to the diametric force ( pg. 20 lines 14-23 disclose a rider 60 capable of translating to an expanded configuration along the track’s setpoints 72a-d upon application of an expansion force ). Lock further teaches that movement of the rider along the track changes the diameter of the tubular biasing element (fig s. 4-5 illustrate that moving a rider 60 along a track 72 changes the diameter of the tubular biasing element as can be seen in figs. 4-5), that the rider is operable to both increase and decrease the diameter of the tubular biasing element upon application of the diametric force (fig. 11 illustrates a ratcheting mechanism that is capable of increasing and decreasing diameter due to the tracks geometry as seen in fig. 11 which would allow for back and forth movement of the track, as opposed to other geometries, e.g. one-way ratchet mechanism, that would not allow for a decrease in diameter as seen in fig. 10 ) , and the diametric force including at least one of a mechanical force and a magnetic force (pg. 10 lines 21-31 and pg. 35 lines 24-26 wherein a balloon catheter was used to apply force and ratchet the diameters of the adjustable mechanism). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted Wu’s adjustment mechanism with Lock’s adjustment mechanism that include s a track and rider, the rider configured to translate along the track in response to the diametric force, wherein movement of the rider along the track changes the diameter of the tubular biasing element, wherein the rider is operable to both increase and decrease the diameter of the tubular biasing element upon application of the diametric force, the diametric force including at least one of a mechanical force and a magnetic force with a reasonable expectation for yielding an adjustment mechanism that change s the diameter of an endoprosthesis to accommodate the patients’ needs , e.g. growth (Lock - Abstract) . Regarding claim 21, Wu in view of Lock disclose s the invention as claimed as discussed with respect to claim 20. Wu in view of Lock further discloses that the track is associated with an outer surface of the tubular biasing element (fig s. 4-5 illustrate a track that is associated with the outer surface of the tubular biasing element /frame in that the outer surface of the tubular biasing element /frame changes diameter in response to the movement of the track) , the track defining the first, second, and third diametric setpoints ( fig. 11, 72a-c). Regarding claim 22, Wu in view of Lock disclose s the invention as claimed as discussed with respect to claim 21. Wu in view of Lock further discloses that the track 70 defines a stepped path between the first, second, and third diametric setpoints (see fig. 11 with stepped path/teeth 72) . Regarding claim 23, Wu in view of Lock discloses the invention as claimed as discussed with respect to claim 21 . Lock teaches an alternate embodiment in fig. 13 in which the track defines a substantially straight path between the first diametric setpoint and the second diametric setpoint (see fig. 1 2 annotated below). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Wu in view of Lock to include that a track defines a substantially straight path between the first and second diametric setpoints as taught by Lock’s alternate embodiment as substituting the track (70) and diametric setpoints ( 72a-d ) in fig. 9 for the track (80) and diametric setpoints (82) of Lock’s embodiment in fig. 13 would serve the same purpose of allowing the valve to change in diameter (Lock pg. 20 lines 15-23) . Regarding claim 24, Wu in view of Lock disclose s the invention as claimed as discussed with respect to claim 20. Lock further discloses that the rider (60) includes a projection (74) received in the track ( 72; see fig. 1 0 ) . Regarding claim 29, Wu disclose s the invention as claimed as discussed with respect to claim 25. Wu fails to disclose an adjustment mechanism that includes a track and a rider, the rider configured to translate along the track in response to the diametric force, wherein movement of the rider along the track changes the diameter of the tubular biasing element, wherein the rider is operable to both increase and decrease the diameter of the tubular biasing element upon application of the diametric force, the diametric force including at least one of a mechanical force and a magnetic force. Lock also discloses an endoprosthesis (11) that is adjustable in diameter (see Abstract), the endoprosthesis comprising: an implant having an implant diameter (see figs. 4-5); an adjustment mechanism coupled to the implant (figs. 4-5 illustrate an adjustment mechanism 50 coupled to the implant 11), the adjustment mechanism including, a tubular biasing element (figs. 4-5 illustrate an adjustment mechanism 50 comprising a tubular biasing element/frame , formed of elements 60/70, that are coupled to the implant 11) having a biasing force that may be overcome by application of a diametric force to the tubular biasing element (pg. 21 lines 1-3 and lines 7-9 disclose that threshold forces are required to overcome biasing force caused by an interference fit of the tubular biasing element). Lock teaches the adjustment mechanism (50) includes a track (80) and a rider (60) , the rider capable of translating along the track in response to the diametric force ( pg. 20 lines 14-23 disclose a rider 60 capable of translating to an expanded configuration along the track’s setpoints 72a-d upon application of an expansion force ). Lock further discloses that movement of the rider along the track changes the diameter of the tubular biasing element ( figs. 4-5 illustrate that moving a rider 60 along a track 72 changes the diameter of the tubular biasing element /frame as can be seen in figs. 4-5 ) , that the rider is capable of increasing and decreasing the diameter of the tubular biasing element upon application of the diametric force (fig. 11 illustrates a ratcheting mechanism that is capable of increasing and decreasing diameter due to the tracks geometry as seen in fig. 11 which would allow for back and forth movement of the track, as opposed to other geometries, e.g. one-way ratcheting system, that would not allow for a decrease in diameter as seen in fig. 10) , and that the diametric force including at least one of a mechanical force and a magnetic force ( pg. 10 lines 21-31 and pg. 35 lines 24-26 wherein a balloon catheter was used to apply force and ratchet the diameters of the adjustable mechanism ). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted Wu ’s adjustment mechanism with Lock’s adjustment mechanism that includes a track and rider, the rider configured to translate along the track in response to the diametric force, wherein movement of the rider along the track changes the diameter of the tubular biasing element, wherein the rider is operable to both increase and decrease the diameter of the tubular biasing element upon application of the diametric force, the diametric force including at least one of a mechanical force and a magnetic force with a reasonable expectation for yielding an adjustment mechanism that change s the diameter of an endoprosthesis to accommodate the patients’ needs e.g. growth (Lock - Abstract) . Regarding claim 31, Wu discloses the invention as claimed as discuss ed with respect to claim 30. Wu fails to disclose that imparting the diametric force further includes applying at least one of a mechanical force or a magnetic force to the endoprosthesis. Lock also discloses a method comprising: imparting a diametric force (pg. 10 lines 21-31) onto an endoprosthesis (11), the endoprosthesis including, an implant having an implant diameter (see figs. 4-5), and an adjustment mechanism coupled to the tubular implant (figs. 4-5 illustrate an adjustment mechanism 50 coupled to the implant 11), a tubular biasing element (figs. 4-5 illustrate an adjustment mechanism 50 comprising a tubular biasing, formed of elements 60/70, that are coupled to the implant 11), a plurality of diametric setpoints (see fig. 11 , 72a-72d), the plurality of diametric setpoints including a first diametric setpoint, a second diametric setpoint that is larger than the first diametric setpoint, and a third diametric setpoint that is larger than the second diametric setpoint (fig. 11 illustrates a plurality of setpoints in which the first setpoint 72a is smaller than a second setpoint 72b and the second setpoint 72b is smaller than a third setpoint 72c). Lock discloses an adjustment mechanism that expands upon the application of a diametric force ( pg. 9 lines 7-10 ) and specifically teaches that imparting the diametric force further includes applying at least one of a mechanical force or a magnetic force to the endoprosthesis (pg. 10 lines 21-31 and pg. 35 lines 24-26 wherein a balloon catheter was used to apply force and ratchet the diameters of the adjustable mechanism). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted Wu’s adjustment mechanism with Lock’s adjustment mechanism and perform the step of applying at least one of a mechanical force or a magnetic force to the endoprosthesis as taught by Lock with a reasonable expectation for yielding an adjustment mechanism that changes the diameter of an endoprosthesis to accommodate the patients’ needs, e.g. growth (Lock - Abstract). Regarding claim 32, Wu in view of Lock discloses the invention as claimed as discussed with respect to claim 31. Lock further discloses further including applying the mechanical force using a transcatheter device (pg. 10 lines 21-31 and pg. 35 lines 24-26 wherein a balloon catheter was used to apply force and ratchet the diameters of the adjustable mechanism) . Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT ADRIANA BAUTISTA whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-0927 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday-Friday 7:30am-5:00pm . 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, FILLIN "SPE Name?" \* MERGEFORMAT Melanie Tyson can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-272-9062 . 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. /A.G.B./ Examiner, Art Unit 3774 /MELANIE R TYSON/ Supervisory Patent Examiner, Art Unit 3774