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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on November 12th, 2025, has been entered.
Response to Amendment
The claims filed on October 28th, 2025, have been entered. Claims 1-4, 8-10, 13-15, and 23-27 remain pending in the Application. Claims 23-27 have been added by the Applicant.
Response to Arguments
Applicant's arguments filed October 28th, 2025, have been fully considered but they are not persuasive.
Applicant argues that the new claim limitation in claims 1 and 13 that the elastic core is formed of elastomeric fibers is not disclosed by Mazzocca et al. (Pub. No. 2008/0051834). Examiner respectfully disagrees. Mazzocca et al. states in [0021-22] that the core 6 is formed of twisted strands 8 of UHMWPE. As discussed in the Final Rejection dated August 12th, 2025, the elasticity of the core in not compared to any other component or reference material, and is therefore a relative term, meaning that the core of Mazzocca et al. is elastic. Since the term “elastomeric” merely conveys that the fibers/strands are also elastic, and the core 6 is made of multiple fibers/strands 8, Mazzocca et al. discloses the elastic core is formed of elastomeric fibers.
Applicant further argues that Glick (Pub. No. 2012/0245602) does not disclose that spandex/silicon can be used as part of a suture core or as a suture material because the ends of the suture need to be fused/welded together and sealed by a filler material. Examiner respectfully disagrees. Applicant also argues that the advantage gained by the use of spandex/silicon is not needed or relevant in Mazzocca et al. because Mazzocca et al. does not need elasticity to improve the strength and knot tie down properties of their sutures, and gives no indication that the high strength sutures are inadequate for their intended use. In [0024], Glick states that “suitable non-degradable materials which may be utilized to form the sutures include…spandex; silicones,” and the Final Rejection stated that the obviousness of using spandex or silicone as a suture material was obvious in light of this disclosure because one of ordinary skill in the art would be capable of selecting a known material based on the suitability for the intended use of the material in the invention. The disclosure of Glick does not need to provide the exact structure of the claimed invention because Glick was only used to teach a selection of material for the structure of Mazzocca et al., and one of ordinary skill in the art would still find the use of spandex/silicon in place of UHMWPE obvious because the selection of material is being made in light of the intended use of the material. A particular motivation to select a material known in the art is not necessary, as one of ordinary skill in the art would be familiar with the advantages and disadvantages of selecting that material. Furthermore, the “laundry list” argument by Applicant neglects to acknowledge that the list is not simply of random materials, but of known materials for use in sutures.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 4, 9-10, 13, 15, and 23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mazzocca et al. (Pub. No. 2008/0051834).
Regarding claim 1, Mazzocca et al. discloses an elastic suture (2; [0021]; FIGs. 1-3) comprising:
an elastic core (6; [0021] 6 is made of UHMWPE, which is elastic) formed of elastomeric fibers ([0022] 6 is made of strands 8 of UHMWPE); and
a tubular jacket (4) covering the elastic core (FIG. 2), wherein the tubular jacket consists essentially of polyester and UHMWPE ([0021] 4 comprises strands 8 made of UHMWPE and strands 10/12 made of clear/tinted polyester).
Regarding claim 4, Mazzocca et al. further discloses the tubular jacket is elastic ([0021] 8 is made of UHMWPE, which is elastic).
Regarding claim 9, Mazzocca et al. further discloses at least one region of the elastic suture is attached to a fixation device ([0032] the distal end of 2 is attached to 14; FIG. 3).
Regarding claim 10, Mazzocca et al. further discloses the fixation device is a knotless suture anchor ([0032] 14 is a suture anchor that does not have knots).
Regarding claim 13, Mazzocca et al. discloses a surgical assembly for soft tissue repairs (FIG. 3: 2 and 14; [0032]), comprising an elastic flexible coupler (2) attached to a knotless fixation device (14), wherein the elastic flexible coupler has an elastic core (6; [0021] 6 is made of UHMWPE, which is elastic) formed of elastomeric fibers ([0022] 6 is made of strands 8 of UHMWPE).
Regarding claim 15, Mazzocca et al. further discloses the knotless fixation device is an anchor inserted into bone ([0006] the suture can be used in bone operations, where 14 is an anchor that would be inserted into bone).
Regarding claim 23, Mazzocca et al. further discloses the elastomeric fibers are braided ([0021] the strands 8 are braided together to form the core 6).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 2-3, 8, 14, and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mazzocca et al. in view of Glick (Pub. No. 2012/0245602).
Regarding claims 2 and 8, Mazzocca et al. discloses the invention as claimed in claim 1, as discussed above. Mazzocca et al. does not disclose the elastic core is made of elastane, and instead discloses the elastic core is made of UHMWPE.
Glick teaches in the same field of endeavor of sutures (Abstract), and discloses sutures can be formed from UHMWPE and from spandex, otherwise known as elastane ([0024]).
It would have been obvious to one having ordinary skill in the art before the effective filing date to have used spandex, 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.
Regarding claim 3, Mazzocca et al. discloses the invention as claimed in claim 1, as discussed above. Mazzocca et al. does not disclose the elastic core comprises elastic and non-elastic material, and instead discloses the elastic core is made of UHMWPE.
Glick teaches in the same field of endeavor of sutures (Abstract), and discloses sutures can be formed from UHMWPE and also from combinations of known materials, such as relatively elastic spandex and relatively inelastic resins ([0024]).
It would have been obvious to one having ordinary skill in the art before the effective filing date to have used a combination of spandex and resins, 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.
Regarding claim 14, Mazzocca et al. discloses the invention as claimed in claim 13, as discussed above, and further discloses the elastic coupler is an elastic suture (2) comprising a core (6) and a jacket (4) covering the core (FIG. 2: 4 covers 6), wherein the jacket consists essentially of a polyester and UHMWPE ([0021] 4 comprises strands 8 made of UHMWPE and strands 10/12 made of clear/tinted polyester), and wherein the knotless fixation device is a knotless suture anchor ([0032] 14 is a suture anchor that does not have knots). Mazzocca et al. does not disclose the core is silicon, and instead discloses the core is made of UHMWPE.
Glick teaches in the same field of endeavor of sutures (Abstract), and discloses sutures can be formed from UHMWPE and from silicon ([0024]).
It would have been obvious to one having ordinary skill in the art before the effective filing date to have used silicon, 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.
Regarding claim 27, Mazzocca et al. as modified further discloses elastic behavior of the elastic suture is adjusted by insertion of elastic material within the elastic core to form regions of elastic material and adjacent regions of non-elastic material ([0021] the core 6 is formed using strands 8 being twisted together, which are inserted when the suture is being initially constructed; [0023] regions of elastic and non-elastic material are created by alternating sections having trace strands 12 that only extend for part of the suture; the modification by Glick to include additional non-elastic material will create further changes in the regions).
Claim(s) 24-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mazzocca et al. in view of Rousseau et al. (Pub. No. 2010/0037901).
Regarding claims 24-26, Mazzocca et al. discloses the invention as claimed in claim 1, as discussed above, and further discloses the elastic suture has a non-regular pattern (non-regular is defined in the present Specification as including portions of the suture being taken out; in Mazzocca et al. [0023], the trace strands can extend for only parts of the suture with portions taken out to create a varying pattern). Mazzocca et al. is silent the elastic suture has a braid, weave, or knit pattern, stating only that the elastic suture fibers are twisted together ([0021]).
Rousseau et al. discloses that there are three prevalent fabric structures used for the patterns of medical sutures: woven, knitted, and braided ([0055]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have used one of the woven, knitted, or braided patterns for the suture of Mazzocca et al., as taught by Rousseau et al., as the modification would have had the predictable result of providing a known pattern with known properties that would be within the general skill or a worker in the art to select based on the intended use as a matter of obvious design choice.
Conclusion
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/JRM/Examiner, Art Unit 3771
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771