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 13 August 2026 have been fully considered but they are not persuasive. Regarding the argument that Thornton does not teach the amendment to claim 1, Examiner respectfully disagrees. Examiner points out that all materials and objects used in a tensioner have a limit to its elasticity (Young’s modulus) and by selecting a material or object to be used as a tensioner, one must contemplate the limit of its expansion and well as its ability to rebound to its original shape when tension is lessened.
Applicant's arguments filed 13 August 2026 have been fully considered but they are not persuasive. Regarding the argument that McCarthy’s figures 33 & 34 embodiment is non-expandable and thus fails to disclose, teach or suggest the features of claim 5, examiner respectfully disagrees with this assessment. The tension members in MacCarthy are stated to be flexible enough to allow of changing interface conditions between the heart and the splint (column 19 lines 37-47). Examiner points out that if the tension member is flexible in a way that it adapts to different interfaces, it must be expandable to fit around those interfaces.
Applicant's arguments filed 13 August 2026, regarding claim 12, have been fully considered but they are not persuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 16-18, 20, & 22 is/are rejected under 35 U.S.C. 102(a)(1)(2) as being anticipated by US 2011/0066233 hereinafter Thornton.
In regards to Claim 1: A system for approximating papillary muscles of a ventricle of a heart (Thornton, Figure 42; Paragraph 216), the system comprising:
a first heart anchor configured to couple to a first papillary muscle of the ventricle (Thornton, Figure 42 Item 3015; Paragraph 216);
a second heart anchor configured to couple to a second papillary muscle of the ventricle (Thornton, Figure 42 Item 3015; Paragraph 216); and
a tension member configured to extend within the ventricle and couple the first heart anchor to the second heart anchor and apply a tension to approximate the first papillary muscle and the second papillary muscle, the tension member being configured to expand between a first length at a systolic phase of the ventricle and a second length at a diastolic phase to accommodate expansion of the ventricle (Thornton, Figure 42 Item 3010; Paragraph 216 & 217; Examiner interprets the cuff being able to resize in response to repositioning.) the second length being a defined limit of expansion of the tension member, and at least a portion of the tension member being elastic and configured to apply an elastic force between the first length and the second length (Thornton, Paragraph 206; “tether may be inelastic or somewhat elastic”; Examiner interprets an elastic tether being able to conform to a first length in the systolic phase and a second length in the diastolic phase).
In regards to Claim 16: The system of claim 1, wherein a portion of the tension member includes a tether that is non-expandable (Thornton, Figure 42 3010; Paragraph 217; Examiner interprets the twisted part of the suture as non-expandable).
In regards to Claim 17: The system of claim 1, wherein at least one of the first heart anchor or the second heart anchor comprises a cuff (Thornton, Figure 42 Item 3015; Paragraph 216 & 217).
In regards to Claim 18: The system of claim 1, wherein both the first heart anchor and the second heart anchor comprise a cuff (Thornton, Figure 42 Item 3015; Paragraph 216).
In regards to Claim 20: The system of claim 1, wherein at least one of the first heart anchor or the second heart anchor comprises one or more sutures (Thornton, Figure 42 Item 3015, Paragraph 133).
In regards to Claim 22: Thornton teaches all of claim 1, and wherein the tension member is configured to not apply the elastic force at the first length (Thornton, Paragraph 217; Examiner interprets the adjusting of the tensioner to be adjusted to a length where in position 1 there is no elastic force applied).
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.
Claim(s) 4 & 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2011/0066233 hereinafter Thornton.
In regards to Claim 4: Thornton teaches all of claim 1, but does not teach wherein an outer diameter of at least a portion of the tension member is configured to decrease upon the tension member expanding.
Another embodiment of Thornton teaches wherein an outer diameter of at least a portion of the tension member is configured to decrease upon the tension member expanding(Thornton, Paragraph 206; Figure 32 Item 2010; Examiner interprets that since the tether 2010 is somewhat elastic, it would be able to expand length wise. Examiner further points out that due to the law of the conservation of matter, the diameter of the tether must decrease when it is stretched lengthwise. ).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the tension member being elastic as taught in one embodiment of Thornton, to the device of cardiac valve repair taught in Thornton, the motivation being to allow for the heart to complete the cardiac cycle unimpeded.
In regards to Claim 21: Thornton teaches of the system of claim 1, but does not teach wherein the tension member includes an expandable body configured to allow the tension member to expand, the expandable body including an end portion, and a portion of the tension member includes a tether that is non-expandable and is coupled to the end portion of the expandable body.
A separate embodiment of Thornton teaches wherein the tension member includes an expandable body configured to allow the tension member to expand (Thornton, Paragraph 204; Figure 31 Item 1905), the expandable body including an end portion, and a portion of the tension member includes a tether that is non-expandable and is coupled to the end portion of the expandable body (Thornton, Paragraph 204; Figure 31 Item 1705).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the tension member including an expandable body and a tether taught by an embodiment of Thornton to the device for cardiac repair taught in Thornton, the motivation being to provide forces to the ventricle to allow it to better hold its desired shape.
Claim(s) 5-10 & 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2011/0066233 hereinafter Thornton in view of US 6,406,420 hereinafter McCarthy.
In regards to Claim 5: Thornton teaches all of claim 1, but does not teach wherein at least a portion of the tension member includes corrugations configured to allow the tension member to expand.
McCarthy teaches wherein at least a portion of the tension member includes corrugations configured to allow the tension member to expand (McCarthy, Figure 33 & 34; Column 18 Line 16-33; Examiner interprets the braids outside edge to have the hills and ridges enough to be considered corrugated.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the braided tension member taught in McCarthy to the device for cardiac repair of Thornton, the motivation being that a multifiber filament structure of numerous smaller wires can then easily, while reducing the stress level on any individual wire as compared to a solid wire of the same diameter as the multifilament bundle.
In regards to Claim 6: A modified Thornton teaches all of claim 5, and wherein the tension member includes a hose having the corrugations (McCarthy, Figure 33 & 34 Item 404; Column 18 Line 16-33; Examiner interprets the coating on the braids outside edge to have the hills and ridges enough to be considered corrugated.).
In regards to Claim 7: Thornton teaches all of claim 1, but does not teach wherein at least a portion of the tension member includes a woven body.
McCarthy teaches wherein at least a portion of the tension member includes a woven body (McCarthy, Figure 33 & 34; Column 18 Lines 16-39).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the braided tension member taught in McCarthy to the device for cardiac repair of Thornton, the motivation being that a multifiber filament structure of numerous smaller wires can then easily, while reducing the stress level on any individual wire as compared to a solid wire of the same diameter as the multifilament bundle.
In regards to Claim 8: A modified Thornton teaches all of claim 7, and wherein the woven body includes a plurality of strips configured to slide with respect to each other to allow the tension member to expand (McCarthy, Figure 33 & 34; Column 18 Lines 16-39; Examiner interprets the braid shown to allow for expansion when made of an expandible material like silicone.).
In regards to Claim 9: A modified Thornton teaches all of claim 8, and wherein the plurality of strips are configured to slide longitudinally to allow the tension member to expand (McCarthy, Figure 33 & 34; Column 18 Lines 16-39; Examiner interprets the braid shown to slide in relation to one another to allow for expansion.).
In regards to Claim 10: Thornton teaches all of claim 1, but does not teach wherein at least a portion of the tension member includes a plurality of arms configured to scissor to allow the tension member to expand.
Thornton teaches wherein at least a portion of the tension member includes a plurality of arms configured to scissor to allow the tension member to expand (McCarthy, Figure 33 & 34; Column 18 Lines 16-39; Examiner interprets the braid strands to be the plurality of arm that cross each other to make a braid).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the braided tension member taught in McCarthy to the device for cardiac repair of Thornton, the motivation being to allow for the tension member to extend in ways to as to not impede the cardiac cycle.
In regards to Claim 14: A modified Thornton teaches all of claim 10, and comprising a stop configured to set a defined limit that the tension member may expand to (Thornton, Figure 42 Item 3010; Paragraph 217; Examiner interprets the ability to twist and knot up the suture a way to limit the length at which the tension member can expand.).
In regards to Claim 15: A modified Thornton teaches all of claim 14, and wherein the stop is adjustable to adjust the defined limit (Thornton, Figure 42 Item 3010; Paragraph 217; Examiner interprets the ability to twist and knot up the suture a way to limit the length as an action that is able to be knotted and loosened as needed by the user.).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2011/0066233 hereinafter Thornton in view of US 6,406,420 hereinafter McCarthy in further view of WO 2006/086434 hereinafter Powell.
In regards to Claim 11: A modified Thornton teaches all of claim 10, but does not teach a spring coupled to the plurality of arms and configured to apply an elastic force to the plurality of arms.
Powell teaches a spring coupled to the plurality of arms and configured to apply an elastic force to the plurality of arms (Powell, Paragraph 133, Figure 29 Item 2910).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the non-magnetic plate to be fixed to the coil as taught by Chen to the system/structure/component of Ball, the motivation being to provide an appropriately composed tuning component such that it would improve the sound characteristics of the system.
Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2011/0066233 hereinafter Thornton in view of US 2004/0064014 hereinafter Melvin.
In regards to Claim 12: Thornton teaches all of claim 1, but does not teach wherein at least a portion of the tension member includes a piston.
Melvin teaches wherein at least a portion of the tension member includes a piston (Melvin, Paragraph 414; Figure 98 Item 980).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the piston taught in Melvin to the device for cardiac repair taught in Thornton, the motivation being to allow for a the tension member to extend for a set distance as set by the piston travel distance.
In regards to Claim 13: A modified Thornton teaches all of claim 12, and wherein the piston includes a plunger (Melvin, Paragraph 414; Figure 98 Item 981). However, a modified Thornton does not teach wherein the piston includes a spring, the spring configured to apply an elastic force to the plunger.
Another embodiment of Melvin teaches wherein the piston includes a spring; the spring configured to apply an elastic force to the plunger (Melvin, Paragraph 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the Spring taught in another embodiment of Melvin to the device for cardiac repair in a modified Thornton, the motivation being to provide tension on the piston when it is both extended and depressed.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2011/0066233 hereinafter Thornton in view of US 2007/0073274 hereinafter Chin.
In regards to Claim 19: Thornton teaches all of claims 1 & 17, but does not teach the cuff includes a ratcheting lock.
Chin teaches of the cuff including a ratcheting lock (Chin, Paragraph 51, Figure 17 Item 255).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the ratcheting lock taught in chin to the device for cardiac repair in Thornton, the motivation being to locking it into place at a size that is adaptable to the user.
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 NOE R DIETZ whose telephone number is (571)272-1135. The examiner can normally be reached Mon-Fri 8am - 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at (571)-272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/N.R.D./Patent Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
