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 .
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Election/Restrictions
Applicant’s election without traverse of a method of implanting a graft in the reply filed on 6/11/2026 is acknowledged.
Claim 22 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected kit, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/11/2026.
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.
Claim(s) 4-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Adams (2017/0095324A1) in view of ElAttrache (2007/0191849A1) and in view of Dougherty (2016/0374795A1).
In regard to claim 4, Adams teaches a method of implanting an interpositional graft 30 onto a proximal humerus (B2) of a patient having an irreparable rotator cuff tear [0019], the method comprising:
placing a first medial anchor 22 into a humeral head at a first medial location of the proximal humerus; [0075: anchors are implanted into the articular margin of the greater tuberosity of the humerus] (see fig 8B)
placing a first lateral anchor 22 at a first lateral location within the greater tuberosity of the proximal humerus [0075: anchors implanted into the articular margin of the greater tuberosity of the humerus]; (see fib 8B)
positioning the interpositional graft 30 to cover a portion of the proximal humerus
B2 (see fig 8B);
fixing a medial end portion of the interpositional graft 30 to the first medial anchor 22 (see fig 6D);
and fixing a lateral end portion of the interpositional graft 30 to the first lateral anchor 22 (see fig 6D, 7A).
However, Adams does not teach placing a second medial anchor into the humeral head at a second location medial to the greater tuberosity of the proximal humerus, placing a second lateral anchor at a second lateral location within the greater tuberosity of the proximal humerus and it is unclear if Adams teaches the medial anchors are medial to the greater tuberosity.
Doughtry teaches a second medial anchor and a second lateral anchor for extra security in securing the graft. (See additional suture anchors 5600 next to the lateral most and medial most anchors in figure 60).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the additional anchors of Dougherty in the proximal humerus of Adams (therefore being applied medial to the greater tuberosity and within the greater tuberosity when applied to Adams between the current medial and lateral suture anchors of Adams) because this arrangement will provide extra security and this tensioning arrangement will allow tension without introducing spin to the anchors (abstract).
ElAttrach teaches the one or more medial anchors are placed into the humeral head at a first location medial to a greater tuberosity of the humerus. [0030: anchors ensure full contact along the medial footprint of the greater tuberosity; fig 4].
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to extend the graft attachment (via the anchors) of Adams medial to the tuberosity footprint as taught by ElAttrach because this helps redistribute load across the repair site, and the bone in this area is stronger for more stable fixation.
In regard to claim 5, Adams meets the claim limitations as discussed in the rejection of claim 4, and further teaches the portion of the proximal humerus (B2) covered by the interpositional graft 30 includes a portion of the greater tuberosity. [0075; see fig 8A-B]
In regard to claim 6, Adams meets the claim limitations as discussed in the rejection of claim 4, and further teaches the portion of the proximal humerus covered by the interpositional graft 30 extends onto an articular cartilage of a superior lateral portion of the humeral head (see figure 8A).
However, it is not clear if Adams teaches the graft is medial to a tuberosity footprint.
ElAttrach further teaches the portion of the proximal humerus covered by the interpositional graft is medial to a tuberosity footprint [0030: anchors ensure full contact along the medial footprint of the greater tuberosity; fig 4].
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to extend the graft attachment (via the anchors) of Adams medial to the tuberosity footprint as taught by ElAttrach because this helps redistribute load across the repair site, and the bone in this area is stronger for more stable fixation.
In regard to claim 7, Adams meets the claim limitations as discussed in the rejection of claim 4, and further teaches the interpositional graft 30 has a medial width at the medial end portion:
fixing the medial end portion of the interpositional graft 30 to the first medial anchor 2. (see fig 6D) and the anchors are fixed to a superior portion of the humeral head (see anchors 22 applied to superior humeral head B2 in figures 6D
However, Adams does not teach the second medial anchor as claimed.
Doughtry further teaches the second medial anchor 5600 includes securing the medial width (secures tissue in fig 6D, 8A-B). Since Doughtry’s additional anchors are being applied between the medial and lateral anchors of Adams, when applied the additional anchors will also be fixed to a superior portion of the humeral head.
In regard to claim 8, Adams meets the claim limitations as discussed in the rejection of claim 7, and further teaches the interpositional graft 30 has a lateral width at the lateral end portion:
the fixing the lateral end portion of the interpositional graft 30 to the first lateral anchor 22 (fig 6D) and securing the anchors to the superior humeral head (fig 6D, 8A-B).
However, Adams does not teach the second lateral anchor as claimed.
As discussed in the rejection of claim 4, Doughtery teaches a second lateral anchor. 5600 (fig 60) Since the additional anchors of Doughtry will be applied between the medial and lateral anchors of Adams, when applied the lateral anchor of Doughtry will be applied to the greater tuberosity of Adams.
In regard to claim 9, Adams meets the claim limitations as discussed in the rejection of claim 7, and further teaches the interpositional graft 30 has a length between the medial end portion and the lateral end portion (interpreted as the width of the graft), the method further comprising: securing the length (interpreted as the width) of the interpositional graft 30 to the proximal humerus (B2) (see fig 8B, A).
In regard to claim 10, Adams meets the claim limitations as discussed in the rejection of claim 4, and further teaches the interpositional graft 30 has an outer perimeter;
and the portion of the proximal humerus B2 covered by the interpositional graft 30 is bounded by the outer perimeter. (see fig 8B)
In regard to claim 11, Adams meets the claim limitations as discussed in the rejection of claim 10, and further teaches securing the outer perimeter (outer perimeter of the graft 30) to the proximal humerus (B2). As shown in figure 8B, a portion of the outer perimeter is secured to the proximal humerus through the anchors 20 and sutures 21). If the applicant is trying to claim that the anchors are in and around the outer perimeter of the graft, that is not clear from the claim language.
In regard to claim 12, Adams meets the claim limitations as discussed in the rejection of claim 7, and further teaches the interpositional graft 30 has an anterior side portion (portion of 30 facing opposite the bone) and a length between the medial end portion and the lateral end portion (interpreted as the width of 30), the method further comprising:
securing, along the anterior side portion (side of 30 opposite the bone), the length of the interpositional graft 30 to at least one of the proximal humerus (see fig 8B) or a subscapularis muscle.
In regard to claim 13, Adams meets the claim limitations as discussed in the rejection of claim 7, and further teaches the interpositional graft 30 has a posterior side portion (interpreted as the side of 30 facing the bone) and a length between the medial end portion and the lateral end portion (the length is interpreted as the width of graft 30), the method further comprising:
securing, along the posterior side portion (interpreted as the portion of 30 facing the bone), the length (interpreted as the width of 30) of the interpositional graft 30 to at least one of the proximal humerus (secured to the proximal humerus as shown in figure 8B) or an infraspinatus muscle.
Claim(s) 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Adams (2017/0095324A1) in view of ElAttrache (2007/0191849A1) and in view of Dougherty (2016/0374795A1) and further in view of Coleman (WO2017/075608A1).
In regard to claim 14, Adams meets the claim limitations as discussed in the rejection of claim 7, and further teaches the interpositional graft 30 has an anterior side portion (interpreted as the side of 30 facing opposite the bone) and a posterior side portion (interpreted as the side of 30 facing the bone) and further teaches repairing the subscapularis [0121: partial rotator cuff repair was performed on parts of the rotation cuff that were repairable, in this case the subscapularis tendon]
However, Adams securing the anterior side to the tendon.
Coleman teaches a fixation cuff 50 extending from the anterior side portion (side away from the bone), the method further comprising: securing the fixation cuff 50 of the anterior side portion (interpreted as away from the bone; see figure 35; [0152: facilitate the repair of damaged tendon to bone]).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the cuff of Coleman to attach to a subscapularis muscle during the repair of Adams in order to enhance the healing of the damaged tendon [0152] and to avoid inserting an additional suture anchor into the bone.
In regard to claim 15, Adams meets the claim limitations as discussed in the rejection of claim 7, and further teaches the interpositional graft 30 has an anterior side portion (interpreted as the portion of 30 facing away from the bone) and repairing the subscapularis [0121: partial rotator cuff repair was performed on parts of the rotation cuff that were repairable, in this case the subscapularis tendon]
However, Adams does not teach a fixation cuff (cuff is defined in the instant disclosure as excess graft) secured to the tendon.
Coleman teaches a fixation cuff 50 extending from the anterior side portion (side away from the bone), the method further comprising: securing the fixation cuff 50 of the anterior side portion (interpreted as away from the bone; see figure 35; [0152: facilitate the repair of damaged tendon to bone]).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the cuff of Coleman to attach to a subscapularis muscle during the repair of Adams in order to enhance the healing of the damaged tendon [0152] and to avoid inserting an additional suture anchor into the bone.
In regard to claim 16, Adams meets the claim limitations as discussed in the rejection of claim 7, and further teaches the interpositional graft 30 has a posterior side portion (the portion of 30 facing the bone) and repairing the infraspinatus muscle [0121: a partial rotator cuff repair was performed, in this case half the infraspinatus tendon].
However, Adams does not teach a fixation cuff as claimed (cuff is defined in the instant disclosure as excess graft).
Coleman teaches a fixation cuff 50 extending from the posterior side portion (interpreted as towards the bone; see figure 12, a portion of 50 is towards the bone), the method further comprising: securing the fixation cuff of the posterior side portion to a muscle. [0152: facilitate the repair of damaged tendon to bone]).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the cuff of Coleman to attach to the infraspinatus muscle during the repair of Adams in order to enhance the healing of the damaged tendon [0152] and to avoid inserting an additional suture anchor into the bone.
Claim(s) 17-18, 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Adams (2017/0095324A1) in view of Coleman (2017/0143551A1).
In regard to claim 17, Adams teaches a method of implanting an interpositional graft 30 onto a proximal humerus B2 of a patient having an irreparable rotator cuff tear [0019] the interpositional graft 30 having an outer perimeter, (see figure 6D, 7A) the method comprising:
placing one or more medial anchors 22 into a humeral head at a first location [0075: anchors are implanted into the articular margin of the greater tuberosity of the humerus]
placing one or more lateral anchors 22 within the greater tuberosity of the proximal humerus [0075: into articular margin of the greater tuberosity];
positioning the interpositional graft 30 to cover a portion of the proximal humerus (fig 6D-7A), the portion of the proximal humerus including a portion of the greater tuberosity and being bounded by the outer perimeter of the interpositional graft 30 [0075; fig 6D-7A];
fixing a medial end portion of the interpositional graft 30 to the one or more medial anchors 22 (see figure 6D-7A);
and fixing a lateral end portion of the interpositional graft 30 to the one or more lateral anchors 22 (see fig 6D-7A).
While Adams teaches the suture anchors can be placed in other locations than the greater tuberosity of the humerus [0075], Adams does not teach the one or more medial anchors are placed at a first location medial to a greater tuberosity of the proximal humerus. It is not clear from the figures of Adams if the location meets this limitation.
Accordingly, Coleman teaches placing one or more medial anchors into a humeral head at a first location medial to a greater tuberosity of the proximal humerus (fig 30; [0161; 0165; 0055: bone anchors placed in a medial position on the tuberosity])
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to place the medial anchor of Adams medial to a greater tuberosity as taught by Adams because this allows better visualization of the medial footprint and allows for a more stable fixation due to better bone quality.
In regard to claim 18, Adams meets the claim limitations as discussed in the rejection of claim 17, and further teaches debriding, before the positioning the interpositional graft 30, soft tissue from the portion of the proximal humerus to be covered. [0070: B2 may be prepared for the surgical procedure by debriding]
In regard to claim 20, Adams meets the claim limitations as discussed in the rejection of claim 17, and further teaches the interpositional graft 30 has a medial width at the medial end portion (as best understood by the examiner, medial width at the medial end is interpreted to mean the medial side of the graft)
and the fixing the medial end portion of the interpositional graft 30 to the at least one or more medial anchors 22 includes securing the medial width to a superior portion (interpreted as best understood to still refer to the proximal portion) of the humeral head. (see fig 6D; 8B)
It appears the applicant may be trying to state that the suture anchor is placed at a medial most corner of the graft. It is recommended to clarify the claim language if that is what is intended.
In regard to claim 21, Adams meets the claim limitations as discussed in the rejection of claim 20, and further teaches the interpositional graft 30 has a length between the medial end portion and the lateral end portion (length is interpreted as the graft width), the method further comprising: securing the length (interpreted as the width) of the interpositional graft 30 to the proximal humerus (B2). (see figure 8B)
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Adams (2017/0095324A1) in view of Coleman (2017/0143551A1) and further in view of in view of Hart (2008/0027470A1).
In regard to claim 19, Adams meets the claim limitations as discussed in the rejection of claim 17, but does not teach decorticating before positioning the graft.
Hart teaches decorticating, before positioning the interpositional graft, the portion of the proximal humerus to be covered. [0146: in preparation for (therefore before) the bone anchors the surface of the greater tuberosity was decorticated; 0133]
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to decorticate the bone before positioning the graft as taught by Hart because this provides access for stem cell migration [0146].
Allowable Subject Matter
Claim 1-3 are allowed.
In regard to claim 1, the closest prior art Adams (2017/0095324A1) in view of Coleman (WO2017/075608A1) meets all of the claimed limitations except “the medial end portion of the interpositional graft being secured only to the proximal humerus;
fixing a lateral end portion of the interpositional graft to the one or more lateral anchors, the lateral end portion of the interpositional graft being secured only to the greater tuberosity”.
This claim language is interpreted as best understood to mean the sides of the graft can only be directly or indirectly secured to the proximal humerus and not another part of the anatomy.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIE BAHENA whose telephone number is (571)270-3206. The examiner can normally be reached M-F 9-3.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at 571-272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTIE BAHENA/Primary Examiner, Art Unit 3774
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