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 § 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 non-obviousness.
Claims 1-25, 32-34 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Sampson et al. (US 2018/0140421) in view of Eckberg et al. (ECKBERG, DWAIN L., et al. "Mechanics of left ventricular contraction in chronic severe mitral regurgitation." Circulation 47.6 (1973): 1252-1259.) and Loulmet et al. (US 2009/0234318).
Regarding claims 1, 16, 17, 20 and 34, Sampson et al. disclose a method for reshaping a heart ventricle comprising: securing a device (100) into ventricular free wall tissue between a mitral valve plane and a papillary muscle insertion (¶[0044], [0046]), wherein the device comprises a plurality of anchors (102, 103) coupled to a tether (106); reducing a circumference of the ventricular free wall tissue by cinching the device from an uncinched configuration to a cinched configuration (¶[0044]), and locking the device in the cinched configuration (¶[0044]); and reverse-remodeling the heart ventricle (¶[0002],[0065]; creating an end diastolic diameter “ED2” which is closer to a normal value can be regarded as reverse-remodeling).
Sampson et al. disclose reducing a circumference of a ventricle free wall tissue (¶[0044]) but fail to disclose the specific percentage of reduction and therefore fail to disclose how much a length of the tether is reduced. Sampson et al. intend to reduce the circumference of an abnormally enlarged ventricle to treat mitral valve regurgitation (Figures 9-10; Abstract; ¶[0064], [0065]).
Eckberg et al. teach that a normal left ventricle inner circumference is 17.5 cm and an enlarged left ventricle inner circumference for patients suffering from mitral valve regurgitation (page 1252) is 17.9-26.8 cm (page 1255, lines 10-14).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention and in view of Eckberg et al. to have performed the method of Sampson et al. to reduce any of the known enlarged left ventricle inner circumferences to approximately the normal inner circumference as reduction of abnormal left ventricle enlargement is a stated goal of Sampson et al. Using the device of Sampson et al. to achieve these reductions in ventricle inner circumference would result in a 30% reduction of left ventricle inner circumference (and all portions thereof) for at least some patients given the range of enlarged circumferences above. Since the tether (106) of Sampson et al. is held very close to the inner circumference of the left ventricle throughout the circumferential reduction process (Figures 1C-1D; Figures 7A-7B; Figures 8A-8B) a 30% reduction in its circumference would be necessary for at least some of these reductions. Furthermore, it is noted that the claimed “a length of the tether” can be interpreted as the length of the tether between the end anchors (102) if it is asserted that Sampson et al. disclose excess tether length outside of the anchors in, for example, Figures 1C-1F. It is also noted that Applicant’s only support for this limitation is provided in the same way as with Sampson et al. in view of Eckberg et al. (i.e. the circumference of a ventricle, or portion thereof, is reduced by 30% and therefore the tether circumference is as well since it is held closely to the inner wall of the ventricle throughout the reduction as in Applicant’s Figure 11).
Sampson et al. fail to disclose that reverse-remodeling the heart ventricle improves at least an ejection fraction of a patient.
Loulmet et al. teach that a very similar cinching device (e.g. 710; Figure 13) which reduces the circumference of a ventricle (¶[0105]) for treating dilation of a ventricle and/or mitral valve regurgitation (¶[0042], [0104]). Loulmet et al. further disclose using the device adjacent one or more papillary muscles to splint dyskinetic segments of the heart tissue to healthy segments and thereby improve blood flow through the ventricle thus improving ejection fraction.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention and in view of Loulmet et al. to have joined dyskinetic segments of the heart tissue to healthy segments in order to improve blood flow through the ventricle and ejection fraction.
Regarding claims 2, and 21, Sampson et al. fail to disclose that the device is secured approximately 10-20 mm below a mitral valve plane. Sampson et al. disclose that the securing device is positioned somewhere between the mitral valve plane and the papillary muscle insertion (¶[0044]) but fail to disclose all of the specific axial positions of the device within this range.
Loulmet et al. teach that the above device can be positioned at every tenth percent of the total axial length of a heart ventricle (¶[0114]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have secured the device at the claimed location since Loulmet et al. effectively teach that virtually any axial location along a ventricle is suitable for positioning a similar device - including at least some specific locations that would be within the claimed location. Furthermore, it has been held that “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claims 3 and 24, as evidenced by Applicant’s specification, the device spanning from leaflet P1 to leaflet P3 would be approximately 220-230 degrees as claimed (¶[0068] of Applicant’s published application). The device of Sampson et al. spans this distance as well (Figure 1B).
Regarding claim 4, locking the device in the cinched configuration comprises securing a lock member (102 or 103 of Sampson et al.) at a terminal end of the device.
Regarding claim 5, locking the device in the cinched configuration further comprises introducing a pre-selected amount of slack to the tether (¶[0043] of Sampson et al.).
Regarding claim 6, Sampson et al. disclose that the plurality of anchors comprises a first anchor (103) and a terminal anchor (102), and introducing a pre-selected amount of slack to the tether comprises securing a lock member on the tether at a pre-selected distance from the terminal anchor when the device is in the cinched configuration (¶[0046]; [0078]).
Regarding claims 7 and 25, as evidenced by Applicant’s specification, the device spanning from leaflet P3 to leaflet P1 would span between the locations as claimed (¶[0068] of Applicant’s published application). The device of Sampson et al. spans this distance as well (Figure 1B - the device spans from the P3 leaflet to the P1 leaflet).
Regarding claims 8 and 18, as evidenced by Applicant’s specification (¶[0068] of the published application), the device spanning from the P3 leaflet to the P1 leaflet would have the ratio as claimed. The device of Sampson et al. spans from the P3 leaflet to the P1 leaflet (Figure 1B). It is noted that the anchors would prevent the degree of circumferential coverage from changing between diastole and systole.
Regarding claim 9, securing the device into ventricular wall tissue comprises securing a total of 11-16 anchors along ventricular wall tissue (¶[0042 of Sampson et al.).
Regarding claim 10, securing the device into ventricular wall tissue comprises deploying each of the anchors into the ventricle wall sequentially (Figure 21 of Sampson et al.).
Regarding claim 11, 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 anchor deployment simultaneously as claimed since Sampson et al. disclose that their method steps may not be performed sequentially (¶[0084]).
Regarding claim 12, the device further comprises a plurality of force distributing members, wherein each force distributing member is coupled to the tether between two anchors (¶[0042] of Sampson et al.).
Regarding claim 13, securing the device into ventricular wall tissue further comprises positioning a multi-window catheter (a catheter would have two windows or openings - one at each end; ¶[0049] of Sampson et al.) in the ventricle approximately 10-20 mm below the mitral valve plane (as obvious in view of Loulmet et al. and explained above). It is further noted that Loulmet et al. (see below) teach use of a more similar multi-window catheter (Figure 9B) to Applicant’s which would possibly be obvious to use for deployment of the device of Sampson et al.
Regarding claim 14, Sampson et al. fail to disclose that the catheter is reinforced or has a predefined curvature as claimed. Loulmet et al. teach that a delivery catheter for a similar device can be reinforced (¶[0069]) and have a predetermined curve at the distal end in order to more closely approximate the shape of a heart chamber (¶[0064]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention and in view of Loulmet et al. to have provided the catheter of Sampson et al. with a reinforced distal end with a predefined curvature as claimed in order to enhance the strength of the catheter and allow better positioning within a deployment location of a heart chamber.
Regarding claim 15, the mitral valve plane comprises a plane of a mitral valve annulus (¶[0046] of Sampson et al.).
Regarding claim 19, Sampson et al. fail to specifically disclose at what angle the device is secured relative to the mitral valve plane. However, Loulmet et al. teach that almost any angle, including 0 degrees, relative to a ventricle longitudinal axis, may be used for securing a similar device in order to reduce a ventricle circumference (¶[0014]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have deployed the device of Sampson et al. parallel to the mitral valve plane as a suitable angle taught by the prior art for use of a similar device to accomplish the same purpose.
Regarding claim 22, cinching the device from an uncinched configuration to a cinched configuration comprises applying tension to a portion of the device (¶[0046] of Sampson et al.).
Regarding claim 23, the anchors self deploying into tissue via shape-memory can be regarded as part of the transition to the cinched configuration (¶[0049] of Sampson et al.).
Regarding claims 32 and 33, Sampson et al. disclose that reducing of the left ventricle circumference and volume is desirable for treatment of a dilated left ventricle (¶[0006], [0044]). Reduction of left ventricular end systolic and end diastolic diameter is also a direct result of the Sampson et al. method (¶[0065]). Therefore, 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 method of Sampson et al. so that end systolic and end diastolic volume is also reduced as this would likely occur as a consequence of the diameter reduction and would also accomplish a stated objective of Sampson et al. which is reduction of left ventricle volume.
Regarding claim 37, Sampson et al. fail to disclose the specific period of time which the reverse-remodeling occurs. However, Sampson et al. disclose that the device can degrade within a period of 1 month or 3 months (¶[0051]).
Therefore, 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 method of Sampson et al. so that the reverse-remodeling occurs at approximately one month or three months as this would allow the maximum amount of time for the body to perform the reverse-remodeling before the device degrades.
Response to Arguments
Applicant's arguments filed August 12th 2025 have been fully considered but they are not persuasive. Applicant has argued that Sampson et al. intend to allow a range of motion in the heart after cinching and therefore would not seek to cinch by a specific percentage or length. Sampson et al. disclose numerous target diameters to be achieved by cinching in Figures 10-15 and the accompanying text. This would necessarily require a targeted length reduction of the tether. It appears that Applicant may have argued that Sampson et al. teach away from the claimed amount of tether cinching due to the fragile nature of the ventricular tissue. Applicant has further argued that Sampson et al. do not teach reducing the ventricle circumference to a normal circumference - only to some smaller circumference. Sampson et al. disclose reducing the ventricle circumference to below its systolic circumference (Figure 12) which would be a greater than 30% reduction (see attached website reference) as well as other smaller reductions (e.g. Figure 10). Applicant has argued that cinching to reduce the length of a tether implanted into a severely enlarged ventricle by 30% may not result in a normal sized ventricle or a 30% reduction in circumference. The above rejection has asserted that some, not all, of the know enlarged ventricle circumferences, when cinched down to the known normal circumference, would require a 30% reduction - the method of Sampson et al. being applicable to all of these known enlarged ventricles. The tether of Sampson et al. is tightly conformed to the inner circumference of the ventricle and therefore this 30% reduction would require an approximate 30% length reduction of the tether; noting that this appears to be how Applicant is providing 35 U.S.C. 112 support for this limitation as well.
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.
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/THOMAS MCEVOY/Primary Examiner, Art Unit 3771