DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-4, 6, 7, 9, 13, and 17-22 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Powell et al. (USPAP 2006/0229708) in view of in view of Annest et al. (USPAP 2008/0082132), and further in view of USPAP 2006/0030885 (Hyde).
Regarding claim 1, Powell discloses a method for cardiac remodeling comprising an annuloplasty therapy implant, wherein the annuloplasty therapy implant comprises a clip configured for direct attachment to a leaflet of a cardiac valve (see paragraphs [0141] and [0155] disclosing a mitral valve clip may be deployed/implanted to augment the desired valve function before or after papillary or chordal manipulation, wherein a mitral valve clip is capable of attaching directly to a leaflet of the mitral valve as claimed).
Powell discloses positioning a second therapy device (3615) adjacent a wall of the ventricle inferior to the annuloplasty implant and a subannular space of the ventricle (see Figure 37)(inferior to a mitral valve clip deployed/implanted before papillary manipulation), the second therapy device comprising a plurality of tissue anchors (3610) and a tether coupled thereto (Fig. 37; [0140]). The anchors (3610) are secured to the wall of the ventricle (see Fig. 36 or 37), wherein the two locations of the anchors meet the significantly broad requirement of “at least partially about a circumference of the ventricle.” The tether is cinched in the direction indicated by the arrows in Fig. 37 to reshape the circumference of the ventricle [0140], wherein pulling the ventricle walls towards one another is considered to meet the significantly broad requirement of “reshaping the circumference.”
Powell teaches that the mitral valve clip (first therapy device) may be deployed/implanted before the steps of papillary or chordal manipulation (see paragraphs [0141] and [0155]), but Powell fails to explicitly disclose that the mitral valve clip is pre-existing. (The Examiner notes that the term “pre-existing” is given its broadest reasonable interpretation to encompass any period of time in which an implant has been implanted in a patient).
Annest discloses another method of reconfiguring the wall (W) of the ventricle by securing a second therapy device comprising plurality of tissue anchors (septal anchor 48 and wall anchor 50) coupled by a tether (tension member 52) [0049]. Annest discloses the location of the second therapy device is at an inferior portion of the ventricle, below the mitral valve (see Figure 4A-5A). Annest teaches that the second therapy device can be included with other surgical therapies, such as augmenting or replacing a valve surgery [0045]. Annest goes on to teach that the methods of ventricle volume reduction can be applied at any appropriate time during the course of a disease [0046]. As well known in the art, the particular needs of a patient varies based on age, health, fitness, injury, race, height, etc. Therefore, it would have been obvious to one having ordinary skill in the art before the invention was made to have performed the steps of positioning and securing the second therapy device of Powell at a time subsequent to the implantation of a first therapy device, as Annest teaches that reconfiguring the wall of a ventricle can be performed to augment a previous valve surgery. The modification merely involves a combination of known surgical procedures for improving heart function that obtains a predictable result of treating a particular patient’s needs.
Further regarding claim 1, Powell and Annest fail to disclose the plurality of tissue anchors of the second therapy device are deployed using a catheter with a plurality of apertures at the distal end. Hyde discloses a method of remodeling the heart that involves the deployment of a plurality of tissue anchors connected by tethers (see Fig. 4 and 5; [0055]). Hyde teaches that a catheter with a plurality of apertures is used to deploy a plurality of tissue anchors (104A, 104B) in the heart (see catheter 300 in Fig. 6-11). It would have been obvious to one having ordinary skill in the art before the invention was made to have deployed the plurality of tissue anchors of modified Powell with a catheter having apertures at the distal end taught by Hyde, as the modification provides the predictable result of a suitable surgical instrument for achieving the placement of a plurality of tissue anchors.
Regarding claim 2, Powell as modified discloses the plurality of tissue anchors (3610) is movably coupled to a tether, wherein Powell discloses that the length of the tether is shortened relative to the anchors (see [0140]). Additionally, Annest teaches that anchors (48, 50) attached to ventricle walls are moveable relative to a tether (52) [0078; 0080].
Regarding claim 3, Powell as modified discloses at least one tissue anchor (3610) is a self-attaching tissue anchor (see Fig. 37; [0140]). Additionally or alternatively, Annest teaches that anchors (48, 50) are self-attaching (see Fig. 6A-D; [0075]).
Regarding claim 4, Powell as modified discloses that reshaping the ventricle may reduce a distance between a first papillary muscle and a second papillary muscle in the ventricle (see Fig. 36; [0139]).
In regards to claim 6, Powell discloses that the therapy device can be attached to the wall of the left ventricle adjacent the papillary muscle, as shown in Figure 37 [0140].
Regarding claim 7, Powell as modified discloses securing the therapy device comprises attaching the therapy device to a papillary muscle (see Fig. 36 or 37 and paragraph [0139] or [0140]).
In regards to claim 9, a circumference of the ventricle is considered to be the inner surface of the ventricle extending about a longitudinal axis, as indicated in the marked up drawing below). Powell discloses that the clips of the therapy device (3615) can be deployed at the papillary muscles [0139].
Regarding claim 13, Powell fails to explicitly disclose the accessing, positioning, securing, and reconfiguring steps take place one or more weeks after the implantation of the annuloplasty therapy implant. Powell does explain that the mitral valve clip may be deployed/implanted to augment the desired valve function before or after papillary or chordal manipulation ([0141] and [0155]). Powell also suggests that subsequent procedures may be required to adjust the shape of an implant if it is determined that additional coaptation is required [0135]. Annest teaches that the second therapy device can be included with other surgical therapies, such as augmenting or replacing a valve surgery [0045]. Annest goes on to teach that the methods of ventricle volume reduction can be applied at any appropriate time during the course of a disease [0046]. Therefore, it is considered to be within an ordinary level of skill in the art to perform the steps of placing the therapy device (3615) of Powell in a separate procedure one or more weeks after the implantation of the annuloplasty implant (mitral valve clip) in order to provide a treatment based on a particular patient’s needs.
Regarding claim 17, although not explicitly stated, it is understood that pulling the walls of the ventricle towards one another in the method of Figure 37 would result in at least some degree of repositioning the papillary muscles. In another embodiment of Figure 36, Powell illustrates that the papillary muscles may be pulled towards one another [0139-0140]. This is considered to meet the requirement of “repositioning” one or more papillary muscles in the ventricle, as the location of one or more of the papillary muscles is changed with respect to at least some other portion of the ventricle.
Regarding claim 18, Annest discloses reasons for treating heart failure, including cardiomyopathy [0005].
Regarding claim 19, Powell teaches treating mitral valve regurgitation [0003-0007].
Regarding claims 21, Powell teaches treating the mitral valve (Mv) with the disclosed method and placement of the second therapy device in the left ventricle (Fig. 36-37; [0006; 0007]).
Regarding claim 22: Powell discloses imaging in order to correctly position the catheter and implants [0071].
Claim 11 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Powell at al. in view of Annest et al. and Hyde, as applied to claim 1 above, and further in view of US Patent App. Pub. 2006/0025800 (Suresh).
Powell discloses another embodiment of the second therapy device (2910) in Figure 29 that is reduced in length after attachment to the papillary muscles in order to reshape the mitral valve [0135]. Powell discloses this device may have a coating that minimizes the potential for clot formation, but fails to explicitly disclose an anti-proliferative drug coating. Annest also teaches that the anchors (48/50) of the second therapy device may include a drug eluting coating [0079]. Sunesh is in the same field of endeavor, and teaches another therapy device implanted within the ventricle to reduce a dimension thereof [0181]. Sunesh teaches that a therapy device can include an anti-proliferative coating to positively affect healing [0209]. One of ordinary skill in the art at the time the invention was made would have found it obvious to include an anti-proliferative drug coating on the second therapy device of the modified Powell method, as taught by Suresh, in order to provide a desired healing effect.
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 SARAH WEBB ALEMAN whose telephone number is (571)272-5749. The examiner can normally be reached M, Tu, Th, Fr 9am - 3pm.
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, Melanie Tyson can be reached at 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.
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
Prosecution Insights