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 Arguments
Applicant’s arguments with respect to claim(s) 23-29, 34-36 and 38-50 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Status
Claims 23-29, 34-36 and 38-50 are examined below.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 23, 26-28 and 49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Derwin (WO 2014/070903 A2) in view of Trieu (US 2008/0147098 A1).
Regarding claim 23, Derwin teaches a repair implant (200, tissue graft constructions, fig. 5) comprising:
a sheet-like first component (210, first layer, fig. 5) comprising a biological layer (¶ [0083]); and
a reinforcing strand (140, first fibers, fig. 5) interwoven into the first component in a sinusoidal pattern (¶ [0072], the first fiber is comprised of interconnected stitches and form a continuous stitching construction, in order to be continuous the fiber would go in and out of the layers in a sinusoidal patter) such that the reinforcing strand extends through varying depths of a thickness of the sheet-like first component (As the strand goes into the sheet it's going through "varying depths”).
Derwin fails to teach the reinforcing strand is not visible on an opposing side of the sheet-like first component. However, Trieu teaches a biocompatible mesh for vertebral augmentation (i.e. repair of the vertebrae) that includes at least a portion of the reinforcing strand extends only partially through the thickness of the sheet-like first component and is not visible on an opposing side of the sheet-like first component (106, inelastic strands, fig. 3b). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the reinforcing strand of Derwin to include at least a portion of the reinforcing strand extends only partially through the thickness of the sheet-like first component and is not visible on an opposing side of the sheet-like first component as taught by Trieu in order to limit the plurality of first strand from reaching the first maximum extension when the first vertebral bone moves relative to the second vertebral bone (¶ [0002], Trieu).
Regarding claim 26, Derwin further teaches the reinforcing strand is interwoven in a direction extending generally parallel to a longitudinal dimension of the sheet-like first component (see annotated fig. 5, below).
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Regarding claim 27, Derwin further teaches the reinforcing strand is interwoven in a direction extending generally orthogonal to a longitudinal dimension of the sheet-like first component (see annotated fig. 5, below).
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Regarding claim 28, Derwin further teaches the reinforcing strand is interwoven in two or more directions relative to a longitudinal dimension of the sheet- like first component (fig. 5).
Regarding claim 49, Derwin teaches a repair implant (200, tissue graft constructions, fig. 5) comprising:
a sheet-like first component (210, first layer, fig. 5) comprising a biological layer (¶ [0083]); and
a reinforcing strand (140, first fibers, fig. 5) interwoven into the first component with the reinforcing strand extending through varying depths of a thickness of the first component (As the strand goes into the sheet it's going through “varying depths”);
the reinforcing strand is visible on a first side of the first component (fig. 5).
Derwin fails to teach the reinforcing strand is not visible on an opposing side of the sheet-like first component. However, Trieu teaches a biocompatible mesh for vertebral augmentation (i.e. repair of the vertebrae) that includes at least a portion of the reinforcing strand extends only partially through the thickness of the first component such that the reinforcing strand is not visible on an opposing second side of the first component (106, inelastic strands, fig. 3b). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the reinforcing strand of Derwin to include at least a portion of the reinforcing strand extends only partially through the thickness of the sheet-like first component and is not visible on an opposing side of the sheet-like first component as taught by Trieu in order to limit the plurality of first strand from reaching the first maximum extension when the first vertebral bone moves relative to the second vertebral bone (¶ [0002], Trieu).
Claim(s) 24 and 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Derwin in view of Trieu as applied to claims 23 and 49 above, and further in view of Murray (US 2020/0171203 A1).
Regarding claims 24 and 50, Derwin in view of Trieu fails to teach the reinforcing strand is a different color than the first component. However, Murray discloses a scaffold device to repair a torn ligament that teaches the reinforcing strand is a different color than the first component (¶ [0049]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the repair implant of Derwin and Trieu to include the reinforcing strand is a different color than the first component as taught by Murray in order to aid in identifying the sutures during the procedure (¶ [0049], Murray).
Claim(s) 29, 34-35, 38-46 and 48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Derwin in view of Trieu and Kaiser (US 2009/0004146 A1).
Regarding claim 29, Derwin in view of Trieu fails to teach loops used for securing the repair implant to a native structure. However, Kaiser discloses an apparatus for soft tissue attachment that teaches one or more loops (38, suture portion, fig. 2A) within an edge (48, activation region, fig. 2A) of the sheet-like first component or external to the edge of the sheet- like first component (fig. 2A) that are configured to be used for securing the repair implant to a native structure (38, suture portion, fig. 2A). The phrase “configured to be used for securing the repair implant to a native structure” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the suture portion is considered to be capable of being used for securing the repair implant to a native structure. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the repair implant of Derwin and Trieu to include loops used for securing the repair implant to a native structure as taught by Kaiser in order to manipulate the implant to assist in fixing a soft tissue graft with an anchor (¶ [0040], Kaiser).
Regarding claim 34, Derwin teaches a repair implant (200, tissue graft constructions, fig. 5) comprising:
a sheet-like first component (210, first layer, fig. 5) comprising a biological layer (¶ [0083]);
a second component (220, second layer, fig. 5), a first side surface of the second component disposed on the first component (see annotated fig. 5, below), the second component comprising a synthetic material (¶ [0083]) and including a plurality of pores (¶ [0045-0046]); and
a plurality of strands (140, first fibers, 142, second fibers, fig. 5) woven back and forth within the repair implant to form a reinforcing structure extending through the repair implant (¶ [0072], the first fibers are comprised of interconnected stitches and form a continuous stitching construction, in order to be continuous the fiber would go in and out or back and forth between the layers), the plurality of strands extending through varying depths of a thickness of the repair implant (as the strand goes into the sheet it's going through "varying depths”);
the reinforcing strand is visible on a first side of the first component (fig. 5).
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Derwin fails to teach the plurality of strands forming loops that extend beyond an edge. However, Kaiser discloses an apparatus for soft tissue attachment that teaches the plurality of strands forming loops (38, suture portion, fig. 2A) that extend beyond an edge (48, activation region, fig. 2A) of the repair implant (fig. 2A) such that the loops are configured to be used for securing the repair implant to a native structure (38, suture portion, fig. 2A). The phrase “the loops are configured to be used for securing the repair implant to a native structure” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the suture portion is considered to be capable of being used for securing the repair implant to a native structure. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the repair implant of Derwin to include the plurality of strands forming loops that extend beyond an edge as taught by Kaiser in order to manipulate the implant to assist in fixing a soft tissue graft with an anchor (¶ [0040], Kaiser).
Derwin in view of Kaiser fails to teach the reinforcing strand is not visible on an opposing side of the sheet-like first component. However, Trieu teaches a biocompatible mesh for vertebral augmentation (i.e. repair of the vertebrae) that includes at least a portion of the reinforcing strand extends only partially through the thickness of the first component such that the reinforcing strand is not visible on an opposing second side of the first component (106, inelastic strands, fig. 3b). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the reinforcing strand of Derwin and Kaiser to include at least a portion of the reinforcing strand extends only partially through the thickness of the sheet-like first component and is not visible on an opposing side of the sheet-like first component as taught by Trieu in order to limit the plurality of first strand from reaching the first maximum extension when the first vertebral bone moves relative to the second vertebral bone (¶ [0002], Trieu).
Regarding claim 35, Derwin further teaches the biological layer is bioabsorbable (¶ [0040]).
Regarding claim 38, Derwin further teaches the plurality of strands forming loops comprise sutures (¶ [0055]).
Regarding claim 39, Derwin further teaches the sutures comprise absorbable sutures (¶ [0055]).
Regarding claim 40, Derwin further teaches the sutures comprise non- absorbable sutures (¶ [0055]).
Regarding claim 41, Derwin further teaches the first side surface of the second component in contact with the first component is chemically modified to covalently bond the first component and the second component (¶ [0058]).
Regarding claim 42, Derwin further teaches the first side surface of the second component in contact with the first component is chemically modified to ionically bond the first component and the second component (¶ [0058]).
Regarding claim 43, Derwin further teaches the second component comprises one or more strands forming a ripstop pattern (¶ [0053], fig. 5).
Regarding claim 44, Derwin further teaches the sheet-like first component comprises collagen (¶ [0006] and ¶[0043]).
Regarding claim 45, Derwin further teaches the second component comprises a generally solid layer (¶ [0047-0050], one skilled in the art would choose appropriate materials to meet the desired properties) and the plurality of pores are mechanically introduced (¶ [0048], one skilled in the art would recognize the decision of materials would mechanically introduce the pore properties).
Regarding claim 46, Derwin further teaches the synthetic material comprises non-resorbable polyester (¶ [0050]).
Regarding claim 48, Derwin further teaches the first component and the second component are stitched together (¶ [0083]).
Claim(s) 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Derwin in view of Kaiser and Trieu as applied to claim 34 above, and further in view of Ladet (US 2009/0004239 A1).
Regarding claim 36, Derwin in view of Kaiser and Trieu fails to teach a low molecular weight collagen. However, Ladet discloses a multilayer structure with a reinforcement member that teaches a low molecular weight collagen (¶ [0015]) disposed within the pores of the second component. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the repair implant of Derwin, Kaiser and Trieu to include a low molecular weight collagen as taught by Ladet since it is combining prior art elements according to known methods to yield predictable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
Claim(s) 47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Derwin in view of Kaiser and Trieu as applied to claim 34 above, and further in view of Nie (US 2018/0193519 A1).
Regarding claim 47, Derwin in view of Kaiser and Trieu fails to teach ultra-high molecular weight polyethylene. However, Nie discloses a layered implant that teaches the synthetic material comprises ultra-high molecular weight (UHMW) polyethylene (¶ [0010]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the repair implant of Derwin, Kaiser and Trieu to include ultra-high molecular weight polyethylene as taught by Nie since it is a simple substitution of one known element for another to obtain predictable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TERESA M DUDDEN whose telephone number is (571)272-0435. The examiner can normally be reached Monday - Tuesday and Thursday - Friday 7:30 am - 6:00 pm EST.
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/T.M.D./Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774
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