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 .
Status of Claims
Claims 1-28 and 90-93 are pending, of which claims 1-14 have been withdrawn. Therefore, claims 15-28 and 90-93 are examined below.
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.
Claim 26 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
Regarding claim 26 – the claim recites the limitation “securing the tendon” There is insufficient antecedent basis for this limitation in the claim.
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) 15-24, 28, and 90-93 is/are rejected under 35 U.S.C. 103 as being unpatentable over non patent literature titled “In vitro and in vivo evaluation of orthopedic interface repair using a tissue scaffold with a continuous hard tissue-soft tissue transition” (Dickerson) in view of US 2016/0338688 (Nason)
Regarding claim 15, Dickerson discloses a method of repairing a rotator cuff (see abstract), the method comprising:
removing a region of a cortical layer of a humerus to form a decorticated surface (Page 4, wherein a “5-mm hole drilled into the enthesis of the humerus” corresponds to decorticating a surface)
positioning a graft over the decorticated surface (Page 4, “press fitting scaffold into the bone”);
temporarily securing a mineralized face of the graft on the decorticated surface with a removable securement (Page 4, “stabilizing with a small cross pin”), wherein the mineralized face has a thickness that is less than a demineralized face of the graft that is adjacent to the mineralized face (see Fig. 1, wherein the graft has a mineralized region and a thicker demineralized region);
Dickerson discloses suturing a tendon directly to the demineralized face of the graft (Page 4, “flexible segment of the tissue scaffold was sutured to the remaining portion of the tendon”) but doesn't explicitly teach or disclose one or more sutures that do not pass through the graft
Nason discloses a method of repairing a rotator cuff (¶0002) comprising:
suturing a tendon against the demineralized face of the graft (¶0056, where “knots are tied to secure the soft tissue against the bone) with one or more sutures that do not pass through the graft (¶0056, “sandwiching the wick material 10 between the bone and tissue”) and;
removing the removeable securement from the graft (¶0055, “the inserter is removed by pulling it away from the bone surface”) so that the graft is held against the decorticated surface by just the surgically repaired tendon (¶0056, “sandwiching the wick material 10 between the bone and tissue”)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method of Dickerson to include the steps of suturing a tendon against the demineralized face of the graft with one or more sutures that do not pass through the graft and removing the removeable securement so that the graft is held against the decorticated surface by the surgically repaired tendon as taught by Nason, in order to provide a pathway for cells to travel from within the bone to an interface between the bone and soft tissue to promote healing at he bone and soft tissue interface (¶0022).
Regarding claim 16, Dickerson discloses wherein the removable securement comprises one or more prongs (Page 4, wherein “a small cross pin” is understood to have one or more prongs)
Regarding claim 17, Dickerson discloses wherein temporarily securing comprises passing one or more prongs of the removable securement through the graft and into the decorticated surface (Page 4, wherein “securing with a small cross pin” is understood to pin the graft to the decorticated bone surface)
Regarding claim 18, Dickerson discloses wherein removing the removable securement comprises removing the removable securement from between the graft and the tendon (Page 4, “stabilizing with a small cross pin”), leaving the tendon sutured against the graft (Page 4, wherein sutured to the graft corresponds to “sutured against the graft”)
Regarding claim 19, Dickerson further discloses driving one or more prongs of the removeable securement through the decorticated surface to create one or more marrow vents within the humerus into a marrow material (Page 4, “the marrow and blood were allowed to wick up into the structure”)
Regarding claim 20, Dickerson discloses wherein removing the removeable securement includes removing the one or more prongs from the decorticated surface, thereby causing the marrow material to exit the one or more marrow vents and into the graft (Page 4, “the marrow and blood were allowed to wick up into the structure”)
Regarding claim 21, Dickerson doesn't explicitly teach or disclose removing the one or more prongs from the decorticated surface by pulling a tether attached to the removable securement.
Nason discloses removing the one or more prongs (see Fig. 8, wherein 8 has two prongs) from the decorticated surface by pulling a tether attached to the removeable securement (¶0061, wherein “the anchor is pulled upwardly by the floating suture 34” corresponds to pulling a tether attached to the removeable securement)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method of Dickerson to remove the removeable securement from the decorticated surface by pulling a tether attached to the removeable securement, as taught by Nason, in order to control the deployment of the graft.
Regarding claim 22, Dickerson doesn't explicitly teach or disclose pulling the tether in a non-perpendicular direction with respect to a long axis of the one or more prongs.
Nason discloses pulling the tether in a non-perpendicular direction with respect to a long axis of the one or more prongs (see Fig. 9, wherein the suture 34 are arranged with respect to the long axis)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method of Dickerson to pull the tether in a non-perpendicular direction with respect to a long-axis of one or more prongs, as taught by Nason, in order to remove the prongs without any damage to the decorticated surface
Regarding claim 23, Dickerson doesn't explicitly teach or disclose pulling the tether causes the removeable securement to pivot such that the one or more prongs exit corresponding one or more opening within the decorticated surface.
Nason discloses wherein pulling the tether causes the removeable securement to pivot such that the one or more prongs exit corresponding one or more opening within the decorticated surface (see annotated Fig. 15 below)
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It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method of Dickerson to pull the tether causes the removeable securement to pivot such that the one or more prongs exit corresponding one or more opening within the decorticated surface, as taught by Nason, in order to remove the prongs without any damage to the decorticated surface
Regarding claim 28, Dickerson discloses a method of repairing a tissue, the method comprising:
removing a region of a cortical layer of a bone to form a decorticated surface (Page 4, wherein a “5-mm hole drilled into the enthesis of the humerus” corresponds to decorticating a surface);
positioning a graft over the decorticated surface (Page 4, “press fitting scaffold into the bone”); and
temporarily securing a mineralized face of the graft on the decorticated surface with a removable securement (Page 4, “stabilizing with a small cross pin”), wherein the mineralized face has a thickness that is less than a demineralized face of the graft that is adjacent to the mineralized face (see Fig. 1, wherein the graft has a mineralized region and a thicker demineralized region)
Dickerson discloses suturing a tendon directly to the demineralized face of the graft (Page 4, “flexible segment of the tissue scaffold was sutured to the remaining portion of the tendon”) but doesn't explicitly teach or disclose suturing a tendon against the demineralized face of the graft with one or more sutures that do not pass through the graft
Nason discloses a method of repairing a rotator cuff (¶0002) comprising:
suturing a tendon against the demineralized face of the graft (¶0056, where “knots are tied to secure the soft tissue against the bone) with one or more sutures that do not pass through the graft (¶0056, “sandwiching the wick material 10 between the bone and tissue”) and;
removing the removeable securement from the graft (¶0055, “the inserter is removed by pulling it away from the bone surface”) so that the graft is held against the decorticated surface by just the surgically repaired tendon (¶0056, “sandwiching the wick material 10 between the bone and tissue”)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method of Dickerson to include the steps of suturing a tendon against the demineralized face of the graft with one or more sutures that do not pass through the graft and removing the removeable securement so that the graft is held against the decorticated surface by the surgically repaired tendon as taught by Nason, in order to provide a pathway for cells to travel from within the bone to an interface between the bone and soft tissue to promote healing at he bone and soft tissue interface (¶0022).
Regarding claim 90, Dickerson doesn't explicitly teach or disclose repairing the tendon with the one or more sutures used to suture the tendon against the demineralized face of the graft.
Nason discloses repairing the tendon with the one or more sutures used to suture the tendon against the demineralized face of the graft (¶0056, the repair is completed”)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method of Dickerson to repair the tendon with the one or more sutures used to suture the tendon against the demineralized face of the graft, as taught by Nason, in order to restore strength and stability to the rotator cuff.
Regarding claim 91, Dickerson discloses a graft with a demineralized face (see rejection of claim 15) but doesn't explicitly teach or disclose pulling the tendon onto the demineralized face of the graft.
Nason discloses pulling the tendon onto the demineralized face of the graft (¶0056, “sandwiching the wick material 10 between the bone and tissue”)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method of Dickerson to pull the tendon over the demineralized face of the graft, as taught by Nason, in order to improve soft tissue to bone repair (Abstract)
Regarding claim 92, Dickerson further discloses reinforcing the tendon to the graft with additional materials (Page 4, wherein “the flexible segment of the tissue scaffold was sutured to the remaining portion of the tendon and muscle” corresponds to a reinforcement with additional materials)
Regarding claim 93, Dickerson further discloses securing the removeable securement via prongs within retention holes (Page 4, “small cross-pin”) formed on the decorticated surface (see Fig. 2, 5-mm hole), wherein the retention holes provide access to marrow material and blood (Fig. 2, “blood and nutrients from the marrow space are wicked into the porous mesh), further comprising the marrow material seeping onto the graft via the retention holes to promote healing (Fig. 2, wherein blood marrow and nutrients are configured to promote healing)
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over non patent literature titled “In vitro and in vivo evaluation of orthopedic interface repair using a tissue scaffold with a continuous hard tissue-soft tissue transition” (Dickerson) in view of US 2016/0338688 (Nason), as applied to claims above, and further in view of non-patent literature titled “Rotator Cuff Healing and the Bone Marrow “Crimson Duvet” From Clinical Observations to Science” (Synder)
Regarding claim 24, Dickerson discloses a decorticated surface (see rejection of claim 15) but doesn't explicitly teach or disclose forming microfractures in the decorticated surface. Nason doesn't explicitly teach or disclose forming microfractures in the decorticated surface.
Synder discloses forming microfractures in the decorticated surface (Page 132, “Multiple 1.5mm puncture holes (bone marrow vents or microfractures) are created in the tuberosity bone using a bone punch or awl”
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method of Dickerson in view of Nason to form microfractures in the decorticated surface, as taught by Synder, in order to optimize the natural healing process made available by a robust bone marrow clot (end of abstract)
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over non patent literature titled “In vitro and in vivo evaluation of orthopedic interface repair using a tissue scaffold with a continuous hard tissue-soft tissue transition” (Dickerson) in view of US 2016/0338688 (Nason), as applied to claims above and further in view of 2009/0216270 (Humphrey)
Regarding claim 25, Dickerson discloses suturing a tendon (see rejection of claim 15) but doesn't explicitly teach or disclose anchoring the one or more tendon-securing sutures to the humerus outside of the decorticated region. Nason doesn't explicitly teach or disclose anchoring the one or more tendon-securing sutures to the humerus outside of the decorticated region
Humphrey discloses anchoring the one or more tendon-securing sutures (Fig. 17, S1) to the humerus outside of the decorticated region (see Fig. 17, wherein suture S1 is anchored to non-decorticated region)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method of Dickerson in view of Nason with a step to anchor the one or more tendon-securing sutures to the humerus outside of the decorticated region, as taught by Humphrey, in order to avoid issues with loosening associated with anchoring suture to decorticated bone (¶0013, ¶0027)
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over non patent literature titled “In vitro and in vivo evaluation of orthopedic interface repair using a tissue scaffold with a continuous hard tissue-soft tissue transition” (Dickerson) in view of US 2016/0338688 (Nason), as applied to claims above, and further in view of US 2009/0318960 (Burkhart)
Regarding claim 26, Dickerson doesn't explicitly teach or disclose crossing the one of more tendon-securing sutures over the tendon. Nason doesn't explicitly teach or disclose crossing the one of more tendon-securing sutures over the tendon.
Burkhart discloses a method of rotator cuff repair (¶0003) comprising crossing the one or more tendon-securing sutures over the tendon (¶0010, wherein the criss-cross pattern over the soft tissue corresponds to crossing over the tendon)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method of Dickerson in view of Nason with a step to cross the one or more tendon-securing sutures over the tendon, as taught by Burkhart, in order to reduce the “dog ears” (i.e. redundant tissue at the margin of the tissue to be repaired) as the sutures compress the tendon.
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over non patent literature titled “In vitro and in vivo evaluation of orthopedic interface repair using a tissue scaffold with a continuous hard tissue-soft tissue transition” (Dickerson) in view of US 2016/0338688 (Nason), as applied to claims above, and further in view of US 2010/0174368 (Lynch)
Regarding claim 27, Dickerson doesn't explicitly teach or disclose suturing a tendon against the demineralized face of the graft with one or more sutures that do not pass through the graft (see rejection of claim 1). Nason doesn't explicitly teach or disclose wherein suturing the tendon comprises suturing the tendons of one or more of: the supraspinatus muscle, infraspinatus muscle teres minor muscle or the subscapularis muscle.
Lynch discloses wherein suturing the tendon comprises suturing the tendons of one or more of: the supraspinatus muscle, infraspinatus muscle teres minor muscle or the subscapularis muscle (¶0293, “infraspinatus tendon”)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method of Dickerson in view of Nason to repair the infraspinatus tendon, as taught by Lynch, in order to restore strength and stability to the rotator cuff.
Conclusion
Included below is relevant prior art that was considered but not relied upon for this office action:
Dandu, Navya, et al. "Arthroscopic rotator cuff repair with biphasic interpositional allograft augmentation." Arthroscopy Techniques 11.4 (2022): e483-e489.
Snyder, Stephen J., and Joseph Burns. "Rotator cuff healing and the bone marrow “crimson duvet” from clinical observations to science." Techniques in Shoulder & Elbow Surgery 10.4 (2009): 130-137 – disclose microfractures of the marrow space (i.e. marrow venting)
US 2007/0198087 – grafts used in rotator cuff repair (¶0009)
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/MAXIMILIAN TOBIAS SPENCER/Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
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