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 .
Response to Amendment
In response to the amendment filed on 06/16/2026, No Claims have been cancelled, and Claims 1-23 are pending.
Election/Restrictions
Applicant’s election WITHOUT traverse of GROUP I in the reply filed on 06/16/2026 is acknowledged. Claims 21-23 have been withdrawn from further consideration and claims 1-20 are pending.
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 6 is 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 6 recites the limitation "the least one flexible strand" in Line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "the least one flexible strand" in Line 3. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 1-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ferree (US PGPub 2007/0135920) in view of Takizawa (US PGPub 2011/0202065).
Regarding Claim 1, teaches a method of soft tissue repair comprising:
securing at least one flexible coupler (4; Figure 1C-1D and Figure 1F) to a fixation device (2; Figure 1C-1D; Paragraph 0063);
securing the fixation device (2) to an inserter shaft (12; Figure 1F; Paragraph 0065),
inserting the fixation device (2) into a bone hole (5) with the inserter shaft (12; Figure 1F; Paragraph 0065); and
providing a solidifying material (20; Figure 1H) to secure the at least one flexible coupler (4) within the bone hole (5; Figure 1H; Paragraph 0067).
Ferree fails to teach:
wherein the inserter shaft is cannulated and provided with a plurality of vent holes;
providing the solidifying material through the plurality of vent holes of the inserter shaft.
Takizawa teaches a bone cement injection needle (abstract) comprising a inserter shaft (406; Figure 13A-13B) which is configured to deliver a needle/medical device (402; see Figures 13A-13B and Figure 19; Paragraph 0115), wherein the inserter shaft (406) is cannulated an provided with a plurality of vent holes (422; Paragraph 0121) and Takizawa teaches providing the solidifying material through the plurality of vent holes (422) of the inserter shaft (406) (Paragraph 0142).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the to modify the inserter shaft of Ferree, to be cannulated with a plurality of holes for dispending solidifying material, as taught by Takizawa, for the advantage of eliminating the need for a separate cement injection tool and thus reducing the amount of steps needed to complete that soft tissue repair.
Regarding Claim 2, the combination of references disclosed above teaches the method of claim 1, Ferree teaches wherein the at least one flexible coupler (4) is attached to soft tissue to be secured to bone (Paragraph 0011).
Regarding Claim 3, the combination of references disclosed above teaches the method of claim 1, wherein Ferree teaches the at least one flexible coupler (4) is suture, suture tape, or porous suture (Paragraph 0063).
Regarding Claim 4, the combination of references disclosed above teaches the method of claim 1, wherein the solidifying material (20) includes at least one bonding material (Paragraph 0067-0068).
Regarding Claim 5, the combination of references disclosed above teaches the method of claim 1, wherein Ferree teaches the solidifying material (20) includes bone cement (Paragraph 0067-0068).
Regarding Claim 6, the combination of references disclosed above teaches the method of claim 1, wherein Ferree teaches the fixation device (5) is an eyelet (35) with a through-opening (See Figures 4A-4C), and wherein Ferree teaches the method further includes slidingly passing the at least one flexible strand (4) through the through-opening (37) of the eyelet (35; Paragraph 0081-0082).
Regarding Claim 7, the combination of references disclosed above teaches the method of claim 1, wherein Ferree teaches inserting the fixation device (2) into a bone hole is conducted with the inserter shaft (12; Figure 1F; Paragraph 0065).
Regarding Claim 8, the combination of references disclosed above teaches the method of claim 1, wherein Ferree teaches the soft tissue is rotator cuff (Paragraph 0011).
Regarding Claim 9, the combination of references disclosed above teaches the method of claim 1, wherein the soft tissue repair is a knotless repair (Paragraph 0086).
Claim(s) 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ferree (US PGPub 2007/0135920) in view of Maale (US Patent 4,653,487)
Regarding Claim 10, Ferree teaches a method of soft tissue repair comprising:
securing at least one flexible coupler (4) to soft tissue to be attached to bone (Paragraph 0011);
securing the at least one flexible coupler (4) to a fixation device (2; Figure 1C-1D; Paragraph 0063),
securing the fixation device (2) with the at least one flexible coupler (4) into a bone hole 5; Figure 1F); and
subsequently, providing a solidifying material (20; Figure 1H) to secure the at least one flexible coupler (4) within the bone hole (5; Figure 1I).
Ferree fails to teach:
wherein the fixation device has a cannulated anchor body provided with a plurality of vent holes;
providing the solidifying material through the plurality of vent holes of the fixation device.
Maale teaches an implant for cement injection (abstract) wherein the fixation device (10; Figures 1-3) has a cannulated anchor body (Figure 1-3) provided with a plurality of vent holes (26; Figure 5) and providing the solidifying material (56; Figure 3) through the plurality of vent holes (26; Figure 3) of the fixation device (10) (Column 4, Lines 29-51).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the fixation device of Ferree, such that it was cannulated and provided with a plurality of vent holes, as taught by Maale for the advantage of deploying the solidifying material straight to the space between the fixation device and the bone, rather than around the fixation device and letting the material settle in the tract.
Regarding Claim 11, the combination of references disclosed above teaches the method of claim 10, wherein Ferree teaches the solidifying material (20) consists essentially of one or more liquified materials (Paragraph 0012, furthermore since the adhesive is flowable, its liquified and furthermore, the adhesive has some level of water/moisture).
Regarding Claim 12, the combination of references disclosed above teaches the method of claim 10, wherein Ferree teaches further comprising passing the at least one flexible strand (4) through a suture eyelet (37) and attaching the suture eyelet to the fixation device (Paragraph 0081-0082).
Allowable Subject Matter
Claim 13 is 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.
Regarding Claim 13, the combination of references disclosed above teaches the method of claim 10, fails to disclose providing a solidifying material is conducted by injecting the solidifying material with an injection device and through a plurality of through-holes in the at least one flexible coupler.
Claims 14-20 are allowed.
Regarding Claim 14, the prior art of record fails to disclose a method of soft tissue repair comprising:
securing at least one flexible coupler to soft tissue to be attached to bone;
providing a solidifying material into a bone hole formed into the bone;
subsequently, inserting the at least one flexible coupler into the bone hole and into the solidifying material, to secure the at least one flexible coupler within the bone hole.
Claims 15-20 are allowable for depending on subject matter of Claim 14.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMED GAMIL GABR whose telephone number is (571)272-0569. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 270-5953. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMED G GABR/Primary Examiner, Art Unit 3771
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