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 .
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.
Claims 3-5 are 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 3 recites “a fourth portion of the side wall distal to the second longitudinal end.” It is unclear how the fourth portion can be distal to the second longitudinal end when claim 2 previously recites “a second portion of the side wall distal to the first longitudinal end,” which defines the first longitudinal end of the anchor tube (17A in Fig. 1) to be the proximal end which then means the second longitudinal end of the anchor tube (17B in Fig. 1) is the distal end. If the second longitudinal end is the distal end, it is not possible for the fourth portion to be distal to that point. In the interest of compact prosecution, Examiner interprets claims 3 to recite “a fourth portion of the side wall proximal
Claims 4 and 5 are rejected based upon their dependency from claims 2 and 3.
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 27 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rodriguez et. al. (U.S. Pub. No. 20150173739) hereinafter, “Rodriguez.”
Regarding claim 27, Rodriguez teaches a tissue joining implant system (400; Fig. 22A), comprising:
an anchor body (404; Fig. 22A) comprising an annular side wall defining an internal cavity (pp. [0070]), a first longitudinal end (see annotated Fig. 22A below) and a second longitudinal end (see annotated Fig. 22A below);
a suture (402; Fig. 22A) that extends through the side wall of the anchor body (404) a plurality of times and forms a free loop portion (see annotated Fig. 22A below) that extends from the side wall; and
at least one suture passer (440 and 442 in combination; Fig. 22A) extending through a portion of the loop portion (see annotated Fig. 22A below) of the suture (402) configured to translate first (410; Fig. 22A) and second end (412; Fig. 22A) portions of the suture (402) through the loop portion via translation of the at least one suture passer (440, 442, pp. [0110]); and
wherein the suture (402) extends along a pattern that allows the suture (402) to slide through the anchor body (404) when the first and second end portions of the suture (410, 412) are tensioned (pp. [0111]);
wherein the at least one suture passer comprises a first suture passer (440) and a second suture passer (442), and wherein the first suture passer and the second suture passer extend through a first cross-section of the suture of the loop portion along a length of the suture (see that the passers cross eachother within the suture, at multiple cross-sections, at the bottom of the anchor; it is noted that this limitation does not require the first cross-section to be at/through the loop portion - although the cross-sections above can be considered as within the loop portion).
However, the embodiment in Figs. 22A-22B of Rodriguez does not explicitly disclose the anchor body as a tube with an internal cavity. The embodiments shown in Figs. 9, 18D and 18E of Rodriguez teach the anchor body can be anchor tube with at least one opening and an internal cavity (pp. [0070] and see Figs. 18D and 18E).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the embodiment in Figs. 22A-22B of Rodriguez to incorporate the teachings of the embodiment in Figs. 18D by making the anchor body an anchor tube with at least one open end defining a cavity (see outlined area in annotated Fig. 22A below). Doing so would allow the anchor body to deform similarly to the anchor bodies shown in Figs. 14, 18C, 20B, and 20D when the suture is tensioned, providing further securement within the bone hole as taught by Rodriguez (pp. [0007]).
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Claims 1-12, 15-16, 23-26, 28-30 and 32-35 are rejected under 35 U.S.C. 103 as being unpatentable over Rodriguez in view of Brown et al. (US 2013/0123810; hereinafter, “Brown”).
Regarding claim 1, Rodriguez teaches a tissue joining implant system (Fig. 9), comprising the limitations listed above in regard to claim 27 or:
an anchor tube (70; Fig. 9) comprising an annular side wall defining an internal cavity (pp. [0070]), a first longitudinal end (see annotated Fig. 9 below) and a second longitudinal end (see annotated Fig. 9 below);
a suture (82, 84; Fig. 9) that extends through the side wall of the anchor tube (70) a plurality of times and forms a free loop portion (see annotated Fig. 9 below) that extends from a first side of the side wall (see that the free loop portion below enters and exits the anchor tube at the bottom of the sidewall); and
at least one suture passer (90 and 94 in combination; Fig. 9) extending through a portion of the loop portion (see Fig. 9) of the suture (82, 84) configured to translate first (82; Fig. 9) and second end (84; Fig. 9) portions of the suture (82, 84) through the loop portion via translation of the at least one suture passer (90, 94, it is noted the claim does not require the at least one suture passer carry out the recited function, but merely be “configured” to perform the recited function. While Rodriguez does not explicitly disclose the at least one suture passer translating both ends of the suture through the loop portion in the manner claimed, Rodriguez is configured to perform the recited function in the same manner as the instant invention because there are two suture passers disclosed, each capable of translating an end of the suture through the loop portion); and
wherein the suture (82, 84) extends along a pattern that allows the suture (82, 84) to slide through the anchor tube (70) when the first and second end portions of the suture (82, 84) are tensioned (see Fig. 14, pp. [0046]).
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Rodriguez discloses that tensioning of the first and second end portions deforms the anchor tube from a neutral configuration into a deformed configuratioin (see drawing below in regard to claim 10) but fails to disclose that this tensioning causes the anchor tube to deform over upon itself at the first sidewall as claimed.
However, Brown discloses a similar anchor tube (100; Figures 2 and 3) and further discloses that tensioning of suture end portions causes the anchor tube to fold or deform over upon itself along its longitudinal sidewalls in order to better secure the tube within tissue (¶[0072], [0073]; note that folding at the ends of the anchor is not what is disclosed because this would not help secure the anchor to a tissue hole as intended).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention and in view of Brown to have made the anchor tube (of Figure 9 or 22A) of Rodriguez so that it deforms or folds over upon itself along the sidewall in order to better secure the anchor tube within tissue.
Regarding claim 2, as best understood in view of the 35 USC § 112(b) rejection set out above, Rodriguez teaches the invention as discussed above in claim 1. Rodriguez further teaches the first end portion (82) of the suture extends from a first end of the suture and through a first portion of the side wall (see annotated Fig. 9 above) of the anchor tube (70) from an exterior surface of the anchor tube (70) proximate to the first longitudinal end thereof (see annotated Fig. 9 above) into the internal cavity, extends longitudinally through a portion of the internal cavity toward the second longitudinal end (see annotated Fig. 9 above) of the anchor tube (70), and extends through a second portion of the side wall (see annotated Fig. 9 above) distal to the first longitudinal end from the internal cavity to the exterior surface of the anchor tube (70).
Alternatively, Rodriguez further teaches the first end portion (410) of the suture extends from a first end (408; Fig. 22A) of the suture (402) and through a first portion of the side wall (see annotated Fig. 22A above) of the anchor tube (404) from an exterior surface of the anchor tube (404) proximate to the first longitudinal end thereof into the internal cavity (see annotated Fig. 22A above), extends longitudinally through a portion of the internal cavity toward the second longitudinal end (see annotated Fig. 22A above) of the anchor tube (404), and extends through a second portion of the side wall distal to the first longitudinal end from the internal cavity (see annotated Fig. 22A above) to the exterior surface of the anchor tube (404).
Regarding claim 3, as best understood in view of the 35 USC § 112(b) rejection set out above, Rodriguez teaches the invention as discussed above in claim 2. Rodriguez further teaches the second end portion (412) of the suture (402) extends from a second end (406; Fig. 22A) of the suture (402) and through a third portion of the side wall (see annotated Fig. 22A above) from an exterior surface of the anchor tube (404) proximate to the second longitudinal end thereof into the internal cavity (see annotated Fig. 22A above), extends longitudinally through a portion of the internal cavity toward the first longitudinal end (see annotated Fig. 22A above), and extends through a fourth portion of the side wall (see annotated Fig. 22A above) proximal to the second longitudinal end as compared to the third portion of the sidewall from the internal cavity to the exterior surface of the anchor tube (see annotated Fig. 22A above).
Regarding claim 4, Rodriguez teaches the invention as discussed above in claim 3. Rodriguez further teaches a first intermediate portion (see annotated Fig. 22A above) of the suture (402) extends from the first end portion (410) that extends through the second portion of the side wall of the anchor tube (see annotated Fig. 22A above), and a second intermediate portion (see annotated Fig. 22A above) of the suture (402) extends from the second end portion (412) that extends through the fourth portion of the side wall of the anchor tube (see annotated Fig. 22A above), and wherein the first and second intermediate portions of the suture form the loop portion (see annotated Fig. 22A above).
Regarding claim 5, Rodriguez teaches the invention as discussed above in claim 4. Rodriguez further teaches the first and second intermediate portions (see annotated Fig. 22A above) of the suture (402) are contiguous portions of the suture (see annotated Fig. 22A above).
Regarding claim 6, Rodriguez teaches the invention as discussed above in claim 1. Rodriguez further teaches tensioning of the first and second end portions of the suture (82, 84) deforms the anchor tube (70) from a neutral configuration (e.g., Fig. 13) into a deformed configuration (e.g., Fig. 14).
Regarding claims 7-8, Rodriguez teaches the invention as discussed above in claim 6.
Rodriguez further teaches, in the deformed configuration (Fig. 14); the anchor tube (70) defines a U-shape (it is noted, the anchor tube having one open end and one closed end (pp. [0070]) makes its deformed configuration a “bowl” shape, which is considered a u-shape).
Regarding claim 9, Rodriguez teaches the invention as discussed above in claim 6. Rodriguez further teaches the anchor tube (70) is deformed or folded over upon itself along a longitudinal length thereof in the deformed configuration (see Fig. 14, showing the anchor tube shortened in a longitudinal direction).
Regarding claim 10, Rodriguez teaches the invention as discussed above in claim 6. Rodriguez further teaches the anchor tube (70) defines a first maximum lateral width and a first maximum longitudinal length in the neutral configuration (see annotated Fig. 13/14 below), and defines a second maximum lateral width that is greater than the first maximum lateral width and a second maximum longitudinal length that is less than the first maximum longitudinal length in the deformed configuration (see annotated Fig. 13/14 below).
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Regarding claim 11, Rodriguez teaches the invention as discussed above in claim 6. Rodriguez further teaches the anchor tube is longitudinally elongated in the neutral configuration (see Fig. 13).
Regarding claim 12, as best understood in view of the 35 USC § 112(b) rejection set out above, Rodriguez teaches the invention as discussed above in claim 11. Rodriguez further teaches the anchor tube (70) is cylindrical in the neutral configuration (“anchoring implant” 70 is described “a three-dimensional tubular shape,” pp. [0070]) .
Regarding claim 15, Rodriguez teaches the invention as discussed above in claim 1. Rodriguez further teaches the suture (82, 84) comprises a multifilament suture (pp. [0010]).
Regarding claim 16, as best understood in view of the 35 USC § 112(b) rejection set out above, Rodriguez teaches the invention as discussed above in claim 15. Rodriguez further teaches the suture (82, 84) is a braided suture (pp. [0010]).
Regarding claim 23, as best understood in view of the 35 USC § 112(b) rejection set out above, Rodriguez teaches the invention as discussed above in claim 1. Rodriguez further teaches the anchor tube (70) is flexible (pp. [0072]).
Regarding claim 24, as best understood in view of the 35 USC § 112(b) rejection set out above, Rodriguez teaches the invention as discussed above in claim 23. Rodriguez further teaches the anchor tube (70) is formed of a hollow braided suture (pp. [0072]).
Regarding claim 25, Rodriguez teaches the invention as discussed above in claim 1. Rodriguez further teaches the at least one suture passer (90, 94) comprises a first suture passer (90; Fig. 9) and a second suture passer (94; Fig. 9).
Alternatively, Rodriguez further teaches the at least one suture passer (440, 442) comprises a first suture passer (440; Fig. 22A) and a second suture passer (442; Fig. 22A).
Regarding claim 26, as best understood in view of the 35 USC § 112(b) rejection set out above, Rodriguez teaches the invention as discussed above in claim 25. Rodriguez further teaches the first suture passer (90) extends through a first portion of the loop portion (the left side) of the suture (82, 84), and the second suture passer (94) extends through a second portion of the loop portion (the right side) of the suture (82, 84).
Alternatively, Rodriguez further teaches the first suture passer (440) extends through a first portion of the loop portion (see annotated Fig. 22A above) of the suture (402), and the second suture passer (442) extends through a second portion of the loop portion (see annotated Fig. 22A above) of the suture (402).
Regarding claim 28, Rodriguez teaches the invention as discussed above in claim 26. Rodriguez further teaches the first suture passer (90) and the second suture passer (94) extend through a common portion of the loop portion (the bottom surface, see Fig. 9) of the suture (82, 84).
Regarding claim 29, Rodriguez teaches the invention as discussed above in claim 26. Rodriguez further teaches the first suture passer passes (90) through the loop portion of the suture along a first direction (see Fig. 9), and the second suture passer (94) passes through the loop portion of the suture along a second direction (see Fig, 9) that substantially opposes the first direction (it is noted, because the “snare” portions of the suture pullers are disposed at opposite longitudinal ends, the suture passers are considered to extend in “opposite” directions) .
Regarding claim 30, Rodriguez teaches the invention as discussed above in claim 26. Rodriguez further teaches the at least one suture passer (90, 94) comprises an exposed loop (see Fig. 9).
Alternatively, Rodriguez further teaches the at least one suture passer (440, 442) comprises an exposed loop (430 and 432; Fig. 22A).
Regarding claim 32, the at least one suture passer (440) extends only through a portion of the loop portion of the at least one suture. Alternatively, the entire portion of the suture containing the suture passer in Figure 9A can be regarded as the loop portion as claimed.
Regarding claim 33, the at least one suture passer extends through a portion of the loop portion of the at least one suture such that a first end portion of the at least one suture passer extends from a first exterior portion of the loop portion of the at least one suture, a second end portion of the at least one suture passer extends from a second exterior portion of the loop portion of the at least one suture, and an intermediate portion of the at least one suture passer extends through an interior portion of the loop portion of the at least one suture between the first and second exterior portions (see that the entire portion of the suture through which the passer 440 extends through is considered as part of the loop portion).
Regarding claim 34, the second end portion of the suture passer comprises an exposed loop (430).
Regarding claim 35, a free first end portion of the at least one suture passer extends exterior of the of the at least one suture from a first portion of the loop portion of the at least one suture, and a second free end portion of the at least one suture passer extends exterior of the of the at least one suture from a second exterior portion of the loop portion of the at least one suture, and an intermediate portion of the at least one suture passer between the first and second free end portions extends within the loop portion of the at least one suture (the entire portion of the suture containing the suture passer in Figure 9A can be regarded as the loop portion as claimed).
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Rodriguez (Fig. 9), Rodriguez (Fig. 22A) in view of Stone et. al. (U.S. Pub. No. 20080027446) hereinafter “Stone.”
Regarding claims 13 and 14, Rodriguez teaches the invention as discussed above in claim 1. Rodriguez further teaches the anchor tube and suture are formed of biodegradable materials (pp. [0014]) but does not explicitly disclose the materials as biocompatible.
Stone teaches a tissue repair system with an anchor tube (100; Fig. 1) and suture (200; Fig. 1) both made of a biocompatible material (pps. [0020]-[0021]).
Stone is considered to be analogous to the claimed invention because it is in the same field of soft tissue repair systems. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the anchor tube and suture of Rodriguez to incorporate the teachings of Stone by making both from biocompatible materials. Doing so would ensure the anchor and suture would not elicit adverse reactions to surrounding tissue as they degrade.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Rodriguez (Fig. 9), Rodriguez (Fig. 22A) in view of Gregoire et. al. (U.S. Pub. No. 20180049863) hereinafter, “Gregoire.”
Regarding claim 17, Rodriguez teaches the invention as discussed above in claim 1. However, Rodriguez does not explicitly disclose the suture is non-hollow.
Gregoire teaches a tissue repair system with an anchor tube (202; Fig. 11) and suture (208; Fig. 11), wherein the suture is non-hollow (pp. [0048]).
Gregoire is considered to be analogous to the claimed invention because it is in the same field of soft tissue repair systems. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the suture of Rodriguez to incorporate the teachings of Gregoire by making the suture non-hollow. Doing so would decrease the overall diameter of the suture allowing for a reduced diameter or footprint of the bone hole as taught by Gregoire (pp. [0048]).
Claims 18-22 are rejected under 35 U.S.C. 103 as being unpatentable over Rodriguez (Fig. 22A) in view of Brown et. al. (U.S. Pub. No. 20130123810) hereinafter, “Brown.”
Regarding claim 18, Rodriguez teaches the invention as discussed above in claim 1. However, Rodriguez does not explicitly disclose at least one insertion device. Rodriguez does teach the end portions of the suture can be passed through tissue without explicitly disclosing how they are passed (pp. [0110]).
Brown teaches a tissue repair system with an anchor tube (800; Fig. 34) and suture (1a & 2a; Fig. 34) with at least one insertion device (1b & 2b; Fig. 34) for passing the suture through tissue (pp. [0125]).
Brown is considered to be analogous to the claimed invention because it is in the same field of soft tissue repair systems. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the tissue repair system of Rodriguez to incorporate the teachings of Brown by adding at least one insertion device to the end portions of the suture. Doing so would provide a means to pass the suture through tissue.
Regarding claim 19, as best understood in view of the 35 USC § 112(b) rejection set out above, Rodriguez in view of Brown teaches the invention as discussed above in claim 18. Brown further teaches the first and second end portions of the suture (1a, 2a) are coupled to the at least one insertion device (1b, 2b, pp. [0124]).
Regarding claim 20, Rodriguez in view of Brown teaches the invention as discussed above in claim 19. Brown further teaches the at least one insertion device (1b, 2b) comprises a first insertion device (1b, Fig. 34) coupled to the first end portion of the suture (1a; Fig. 34), and a second insertion device (2b; Fig. 34) coupled to the second end portion of the suture (1b; Fig. 34).
Regarding claim 21, Rodriguez in view of Brown teaches the invention as discussed above in claim 19. Brown further teaches the at least one insertion device (1b, 2b) comprises at least one needle (pp. [0124]).
Regarding claim 22, as best understood in view of the 35 USC § 112(b) rejection set out above, Rodriguez in view of Brown teaches the invention as discussed above in claim 21. Brown further teaches the at least one needle (1b, 2b) comprises at least one non-linear needle (see Fig. 35).
Response to Arguments
Applicant’s arguments with respect to the pending claims 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.
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 THOMAS MCEVOY whose telephone number is (571)270-5034. The examiner can normally be reached M-F, 9am-6pm (ET).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eric Rosen can be reached at (571) 270-7855. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THOMAS MCEVOY/Primary Examiner, Art Unit 3771
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