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 .
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.
Claim(s) 1, 6, 7-11, 13-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rushdy et al (US 2012/0265219).
Rushdy et al discloses the following limitations:
Claim 1. A surgical method for repairing a tissue defect ([0009], [0038], [0052] e.g. torn ligaments and tendons, including a rotator cuff repair), comprising:
inserting a first knotless suture anchor into a bone (30) ([0059]; a knotless medial suture anchor is placed through location 108);
passing a first loop (112) of the first knotless suture anchor through a graft (4) (Fig. 7; at location 41; [0054], [0055]);
passing a reinforcement construct (S3 + S5) through the first loop or looping the reinforcement construct around the first loop (wherein portion S3 of the reinforcement construct is passed through first loop 112) (Figs. 16-17; [0062]);
tightening the first loop (112) to approximate the graft (4) to the tissue defect (Figs. 11-13; [0057], i.e. the first loop 112 is tightened via pulling on ends 116 of suture S1); and
securing a first tail portion (left tail of S3 in Figs. 16-17) of the reinforcement construct to the bone with a second knotless suture anchor (A1) ([0062]);
wherein the first knotless suture anchor is located beneath the graft after tightening the first loop, and the second knotless suture anchor is located beyond an edge of the graft after securing the first tail portion (Fig. 17 illustrates the anchor under loop 112 is beneath graft 4, and anchor A1 is laterally beyond an edge of the graft 4).
Claim 6. The surgical method as recited in claim 1, wherein the reinforcement construct (S3 + S5) compresses the graft (4) to the tissue defect after tightening the first loop and securing the first tail portion ([0057] discusses tightening of loops 112 and 114 via ends 116 and 118, respectively. This tightening also pulls on the reinforcement construct to achieve the configurations shown in Fig. 17; [0062]. Therefore, this configuration allows the reinforcement construct to compress the graft to the tissue defect after securing of the lateral suture anchors thereby encompassing the claimed language).
Claim 7. The surgical method as recited in claim 1, comprising:
inserting a third knotless suture anchor into the bone (30) ([0059]; another knotless medical suture anchor is placed through location 110);
passing a second loop (114) of the third knotless suture anchor through the graft (4) ([0054]; Fig. 6);
passing the reinforcement construct (portion S3 of reinforcement construct) through the second loop (114) or looping the reinforcement construct around the second loop (Figs. 16-17; [0062]); and
tightening the second loop to further approximate the graft to the tissue defect (Figs. 11-13; [0057], i.e. the second loop 114 is tightened via pulling on ends 118 of suture S2).
Claim 8. The surgical method as recited in claim 7, comprising:
securing a second tail portion (right tail of S3 in Fig. 17) of the reinforcement construct to the bone with a fourth knotless suture anchor (A2) ([0062]).
Claim 9. The surgical method as recited in claim 8, wherein the third knotless suture anchor is located beneath the graft after tightening the second loop, and the fourth knotless suture anchor is located beyond the edge of the graft after securing the second tail portion (Fig. 17 illustrates the anchor under loop 114 is beneath graft 4, and anchor A2 is laterally beyond an edge of the graft 4).
Claim 10. The surgical method as recited in claim 8, wherein, after securing the first tail portion and the second tail portion, the second knotless suture anchor (A1) and the fourth knotless suture anchor (A2) are located on opposite sides of the graft (4) and are laterally beyond the edge of the graft (Fig. 17).
Claim 11. The surgical method as recited in claim 8, wherein the reinforcement construct includes a double “V” pattern after securing the first and second tail portions (see annotated figure below).
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Claim 13. A surgical method for repairing a tissue defect ([0009], [0038], [0052] e.g. torn ligaments and tendons, including a rotator cuff repair), comprising:
fixating a graft (4) over a tissue defect with a knotless tensionable fixation system that includes at least a first knotless suture anchor ([0059]; a knotless medial suture anchor placed through location 108), a second knotless suture anchor (A1), the graft (4), and a reinforcement construct (S3 + S5) (Figs. 16-17), and
the reinforcement construct establishes a fixed segment of material over the graft and is secured in place by at least the first knotless suture anchor and the second knotless suture anchor ([0062], reinforcement construct (S3 + S5) are fixed in place once they are secured with the suture anchors in the bone, that is, the lengths of the sutures S3 and S5 do not change, and are therefore considered a fixed segment of material over the graft once implanted);
wherein the first knotless suture anchor is located beneath the graft and the second knotless suture anchor is located beyond an edge of the graft after fixating the graft over the tissue defect (Fig. 17 illustrates the anchor under loop 112 is beneath graft 4, and anchor A1 is laterally beyond an edge of the graft 4).
Claim 14. The surgical method as recited in claim 13, wherein fixating the graft includes:
inserting the first knotless suture anchor into a bone (30) ([0059]); and
passing a first loop (112) of the first knotless suture anchor through the graft (4) (Fig. 7; at location 41; [0054], [0055]).
Claim 15. The surgical method as recited in claim 14, wherein fixating the graft includes:
connecting the reinforcement construct to the first loop (112) (Figs. 16-17; [0062]).
Claim 16. The surgical method as recited in claim 15, wherein connecting the reinforcement construct to the first loop includes:
looping the reinforcement construct (portion S3 of the reinforcement construct) around the first loop (112) (Fig. 17 shows S3 looped around first loop 112 in order to extend vertically downward towards anchor A1) .
Claim 17. The surgical method as recited in claim 15, wherein connecting the reinforcement construct to the first loop includes:
passing the reinforcement construct (portion S3 of the reinforcement construct) through the first loop (112) (Fig. 16; [0062]).
Claim 18. The surgical method as recited in claim 15, wherein fixating the graft (4) includes:
tightening the first loop (112) to approximate the graft to the tissue defect (Figs. 11-13; [0057], i.e. the first loop 112 is tightened via pulling on ends 116 of suture S1).
Claim 19. The surgical method as recited in claim 18, wherein fixating the graft (4) includes:
securing a first tail portion (left tail of S3 in Figs. 16-17) the reinforcement construct to the bone with the second knotless suture anchor (A1) ([0062]).
Claim 20. The surgical method as recited in claim 19, wherein fixating the graft (4) includes:
securing a second tail portion (right tail of S3 in Figs. 16-17) of the reinforcement construct to the bone with a third knotless suture anchor (A2) ([0062]).
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.
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) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rushdy et al in view of Stone et al (US 2008/0275431) and McKay (US 2008/0262616).
Claim 2. Rushdy et al discloses the invention substantially as claimed above, including the graft is a biologic allograft (0052]) but fails to disclose the allograft is specifically an osteochondral allograft. Instead, Rushdy et al teaches the method is for rotator cuff repairs ([0009]) but the method can also be used in many other possible applications ([0038]).
In the same field of endeavor of method of repairing a tissue defect involving using sutures and anchors, Stone et al teaches rotator cuff repairs can include cartilage repairs ([0021]). Furthermore, McKay teaches specifically in cartilage repairs, osteochondral allografts are used ([0011], [0049], [0050]). Therefore, in light of Rusdhy et al’s disclosure of using the method for other applications, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to use an osteochondral allograft to treat a cartilage defect based upon the teachings of Stone et al and McKay since an injured rotator cuff can include damaged cartilage which would also require repair for a total repair of the rotator cuff.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rushdy et al in view of Pellegrino et al (US 2007/0288023)
Claim 3. Rushdy et al discloses the invention substantially as claimed above, including the graft is a biologic allograft ([0052]) but fails to disclose the allograft is specifically a dermal allograft.
However, in the same field of endeavor, Pellegrino et al teaches a method for repairing a damaged rotator cuff with a graft (130), sutures (114, 116, 118, 120) coupled to a plurality of anchors (110, 112) (Figs. 2A-2C), wherein the graft is a dermal allograft ([0017]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the biologic allograft of Rushdy et al to be a dermal allograft as taught by Pellegrino et al, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim(s) 4 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rushdy et al in view of Trenhaile et al (US 2020/0253715).
Claims 4 and 5. Rushdy et al discloses the invention substantially as claimed above, including the reinforcement construct is formed of sutures ([0055]) but fails to disclose the reinforcement construct (S3 + S5) is an absorbable suture (as per claim 4) or a nonabsorbable suture (as per claim 5).
However, in the same field of endeavor, Trenhaile et al teaches various suture constructs (22, 30) of the invention used in tissue repair can be non-absorbable sutures or absorbable sutures ([0026], i.e. slow resorption type sutures are absorbable sutures). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the reinforcement construct (S3 + S5, which are disclosed as being sutures) of Rushdy et al to be either a absorbable or non-absorbable suture, based upon the teachings of Trenhaile et al, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416 (i.e. depending on the desired characteristics of the suture construct of the reinforcement construct, [0026] discloses various known sutures and properties of sutures in the art that may be used).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rushdy et al.
Claim 12. Rusdhy et al discloses the invention substantially as claimed above, but fails to disclose wherein the reinforcement construct includes a Z-shaped pattern after securing the first and second tail portions in the embodiment of Figs. 16-17. However, Rusdhy et al discloses a variety of other patterns that may be used in other embodiments, including one wherein the reinforcement construct includes a Z-shaped pattern after securing the first and second tail portions (see annotated figure below). Rusdhy et al discloses these configurations allow for load sharing across the graft (4) ([0002], [0004], [0051]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to substitute one configuration (Fig. 17 of Rusdhy et al) with another (Z-shaped pattern of the annotated Fig. 10 below of Rushdy et al) to provide an alternative configuration that would allow for the predictable result of allowing for load sharing across the graft and tension adjustment of the reinforcement construct ([0052]), [0062]).
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Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12075999. Although the claims at issue are not identical, they are not patentably distinct from each other because the elements of claims 1-20 of the instant application are to be found in claims 1-20 of the patent. Thus the difference between claims 1-20 of the instant application and claims 1-20 of the patent lies in the fact that the patent claims include many more elements and is thus much more specific. Thus, the invention of claims 1-20 of the patent is in effect a “species” of the “generic” invention of claims 1-20 of the instant application. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claims 1-20 are anticipated by claims 1-20 of the patent, it is not patentably distinct from claims 1-20 of the patent.
The limitations of the claims in the instant invention can be found in the claims of the corresponding patent:
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Pertinent Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Beaulier et al (US 2020/0261072) teaches a method for knotless tissue repair, wherein Beaulier et al explicitly discloses it is advantageous to place suture anchors beyond the lateral edge (footprint) of a graft to ensure the graft is always tight over the tissue defect ([0029]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE M SHI whose telephone number is (571)270-5620. The examiner can normally be reached Mon-Thurs, 8-5 EST.
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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 M SHI/Primary Examiner, Art Unit 3771
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