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 .
Election/Restrictions
Applicant’s election without traverse of group I in the reply filed on 07/28/2026 is acknowledged.
Claims 26 and 27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected groups II and III, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/28/2026.
Claim Objections
Claim 17 is objected to because of the following informalities: line 2 recites “acn” which should be “an”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9-12 and 17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 9 recites the limitation "the inner tubular member" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the outer tubular member" in lines 2 and 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the tension line" in lines 3 and 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the inner tubular member" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recite “the end cap” in line 2. Since multiple end caps are claimed it is unclear which end cap “the end cap” is referring to.
Claim 12 recites the limitation "the tension line" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation "each end cap" in line 3 and “each of the end caps in line 5. There is insufficient antecedent basis for this limitation in the claim.
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 1-6, 13, 15, 16, and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sugimoto et al. (US 20070010857 A1).
Regarding claim 1 Sugimoto discloses (see fig. 5A-6 and 8A-8E) a soft tissue anchor 70 system for implantation in soft body tissue to hold an artificial line, the anchor 70 comprising:
a U-shaped fabric body 72 comprising a base portion and at least two arm portions extending from the base portion (see annotated fig. 6 below; 72 is a flexible body thus can be in the form of a U and further forms a U-shape in the collapsed configuration);
wherein each arm portion is configured to collapse in folds towards the base portion such that, in use, the body tissue is sandwiched between the base portion and each of the arm portions (see fig. 8D and [0047]).
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Regarding claim 2 Sugimoto further discloses (see fig. 5A-6 and 8A-8E) a tension line 72 threaded through the arm portions and the base portion (see fig. 6 and [0044]); wherein the tension line is configured to collapse each arm portion in folds towards the base portion when a tensile force is applied to the tension line (see [0047]).
Regarding claim 3 Sugimoto further discloses (see fig. 5A-6 and 8A-8E) the tension line 72 is fixed to each arm portion (moveable fixed to the first arm and immovably fixed to the second arm) at an end of the arm portion distal to the base portion (see fig. 6).
Regarding claim 4 Sugimoto further discloses (see fig. 5A-6 and 8A-8E) the tension line 72 is threaded no more than four times through the arm portion and the base portion (each arm and the base portion have 72 threaded through less than 4 times; see fig. 6).
Regarding claim 5 Sugimoto further discloses (see fig. 5A-6 and 8A-8E) the tension line 72comprises a plurality of bridle lines (portion of 72 on either side of 76; see fig. 8A), wherein each bridle line is associated with a respective arm portion (see fig. 8A); and wherein each bridle line is connected to a common bridle point 94 (see fig. 8A and [0045]), wherein the bridle point 94 is configured to place each bridle line under tension when a tensile force is applied to the bridle point 94 (see [0047]).
Regarding claim 6 Sugimoto further discloses (see fig. 5A-6 and 8A-8E) further comprising: the artificial line 72a (see fig. 8A); wherein the artificial line is configured to apply the tensile force (see [0047]).
Regarding claim 13 Sugimoto further discloses (see fig. 5A-6 and 8A-8E) the base portion defines a maximum width of the U-shaped fabric body (see fig. 7).
Regarding claim 15 Sugimoto further discloses (see fig. 5A-6 and 8A-8E) the soft tissue anchor system is a leaflet anchor system for implantation in a heart valve leaflet (see [0044]) to hold an artificial chordae line. The language “the soft tissue anchor system is a leaflet anchor system for implantation in a heart valve leaflet to hold an artificial chordae line” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Sugimoto meets the structural limitations of the claim, and the soft tissue anchor system is a leaflet anchor system capable of implantation in a heart valve leaflet to hold an artificial chordae line. The device is sized for placement into the heart valve and therefore can be placed to hold an artificial chordae line.
Regarding claim 16 Sugimoto further discloses (see fig. 5A-6 and 8A-8E) a catheter device 54 for implanting a soft tissue anchor system in heart tissue, the catheter device comprising:
a housing section 52, wherein the housing section extends from a distal end of the catheter device along the length of the catheter device toward a proximal end of the catheter device 54 (see fig. 5A and [0042]);
and a soft tissue anchor system as claimed in claim 1 located within the housing section (see claim 1 above and fig. 5A).
Regarding claim 22 Sugimoto further discloses (see fig. 5A-6 and 8A-8E) a leaflet anchor 70 for placement in a leaflet of a heart valve (see fig. 5A and [0044]), wherein the leaflet anchor is the soft tissue anchor system, wherein the leaflet anchor is arranged to be coupled to the artificial line 72a (see fig. 8A); and a leaflet anchor deployment mechanism 50 for deploying the leaflet anchor to attach it to the leaflet of the heart (see fig. 5A and [0042]).
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.
Claims 1 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Denham et al. (US 20140074160 A1) in view of Marchand et al. (US 20130131722 A1).
Regarding claim 1 Denham discloses (see fig. 7) a soft tissue anchor 120 system for implantation in soft body tissue to hold an artificial line, the anchor 120 comprising:
a U-shaped fabric body 122 comprising a base portion (center) and at least two arm portions (124B and 124D) extending from the base portion (see fig. 7 and [0047]); 122 is U-shape in the implanted configuration).
Denham does not expressly disclose wherein each arm portion is configured to collapse in folds towards the base portion such that, in use, the body tissue is sandwiched between the base portion and each of the arm portions.
However Marchand, in the same field of endeavor, teaches (fig. 1-3C) a U-shaped fabric body comprising a base portion (center) and at least two arm portions (see fig. 1) wherein each arm portion is configured to collapse in folds towards the base portion (see fig. 2 and [0046]-[0047]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Denham to have each arm portion is configured to collapse in folds towards the base portion as taught by Marchand, for the purpose of increasing the pullout strength of the anchor to improving the holding of the anchor in the bone (see Marchand [0046]-[0047]).
The language “in use, the body tissue is sandwiched between the base portion and each of the arm portions” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Denham as modified meets the structural limitations of the claim, and in use, the body tissue is capable of being sandwiched between the base portion and each of the arm portions as the anchor is capable of being used in tissue.
Regarding claim 14, Denham as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Denham further discloses (see fig. 7) the U-shaped fabric body comprises a narrow waist portion extending between the base portion and each arm portion (see annotated fig. 7 below).
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Allowable Subject Matter
Claims 7 and 8 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.
Claims 9-12 and 17 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include 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, alone or in combination, fails to teach or render obvious each arm portion comprises an end cap fixed at an end of each arm portion distal to the base portion; wherein each end cap comprises an opening configured to engage a wire guide member for implanting the U-shaped fabric body in the body tissue. The closest prior art includes Sugimoto, Staskin et al. (US 20020099258 A1), and Chu et al. (US 20090171143 A1).
Sugimoto discloses one end cap 76, but fails to teach each arm portion comprises an end cap fixed at an end of each arm portion distal to the base portion; wherein each end cap comprises an opening configured to engage a wire guide member for implanting the U-shaped fabric body in the body tissue
Staskin teaches a U-shaped body 42 having a tensile member (support portion; see [0116]) and each arm comprising an end cap 54 (see fig. 4). Staskin however teaches the tensile member is fixed to body 42 at 61 “avoiding undesirable permanent deformation”. Therefore Staskin does not teach and cannot be modified to teach each arm portion is configured to collapse in folds towards the base portion.
Likewise Chu teaches a U-shaped body 2020 having a tensile member 2024 and each arm comprising an end cap 2062 (see fig. 37 and [0150]). Chu however teaches the tensile member is fixed to body at multiple locations. Therefore Chu does not teach and cannot be modified to teach each arm portion is configured to collapse in folds towards the base portion.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Meister et al. (US 20190038277 A1) which teaches a u-shaped anchor that can fold towards the base.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE H MENDEZ whose telephone number is (571)272-9503. The examiner can normally be reached Monday - Friday 8 am-4:00 pm.
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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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/KATHERINE H MENDEZ/Primary Examiner, Art Unit 3771
