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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-32 in the reply filed on May 08, 2025 is acknowledged.
Claims 33 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 08, 2025.
Claim Objections
Claims 3 and 28-32 are objected to because of the following informalities:
Claim 3 recites “an exterior surface of the anchor tube,” in line 3. Examiner suggests claim 3 recite “[[an]]the exterior surface of the anchor tube,” for consistency with claim 2.
There is no claim 27 listed in the current claim set. Therefore, claims 28-32 should be renumber 27-31. Appropriate correction is required.
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 2-5, 12, 16, 19-24 and 26-31 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 2 recites the limitation "the first internal cavity" in line 4. There is insufficient antecedent basis for this limitation in the claim. In the interest of compact prosecution, Examiner interprets claims 2 to recite “the
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.
Claims 12, 16, 19, 22, 24, 26, and 31 have been amended to change their claim number, however, each claim now depends from itself (i.e., claim 12 depends from claim 12 and so on). It is unclear what the scope of each claim is as there is no preceding claim indicated for which each claim depends. In the interest of compact prosecution, Examiner interprets each claim listed to depend from the claim immediately preceding it (i.e., newly amended claim 12 will be interpreted to depend from “old claim 12” which is now amended to be claim 11 and so on).
Claims 20-21 and 27-31 are rejected based upon their dependency from claims 19 and 26 respectively.
Claims 23 and 24 each recite the limitation "the anchor member" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. In the interest of compact prosecution, Examiner interprets claims 23 and 24 to recite “the anchor tube.”
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 6-8, 9-12, 15-16, 23-26, and 28-30 is/are 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 1, Rodriguez teaches a tissue joining implant system (Fig. 9), comprising:
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 the side wall; 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]).
PNG
media_image1.png
544
642
media_image1.png
Greyscale
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).
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).
PNG
media_image2.png
688
844
media_image2.png
Greyscale
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).
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).
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).
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.
For the purposes of rejecting claims 3-5 and 18-22, and 31, a second embodiment of Rodriguez relied upon.
Claim(s) 1-5, 25-26, and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rodriguez (Embodiment shown in Figs. 22A & 22B).
Regarding claim 1, 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]).
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]).
PNG
media_image3.png
644
690
media_image3.png
Greyscale
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 (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 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 25, Rodriguez teaches the invention as discussed above in claim 1. 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 (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 30, Rodriguez teaches the invention as discussed above in claim 26. Rodriguez further teaches the at least one suture passer (440, 442) comprises an exposed loop (430 and 432; Fig. 22A).
Regarding claim 31, as best understood in view of the 35 USC § 112(b) rejection set out above, Rodriguez teaches the invention as discussed above in claim 30. Rodriguez further teaches when the first and second end portions (410, 412) of the suture (402) are translated through the loop portion along a first direction via the at least one suture passer (440, 442) and the first and second end portions (410, 412) are tensioned (pps. [0110]-[0111]), wherein the loop portion applies tension on the first and second end portions (410, 412) sufficient to prevent the first and second end portions (410, 412) from translating through the loop portion along a second direction that opposes the first direction (pps. [0110]-[0111]).
Claim(s) 13-14 is/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(s) 17 is/are 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]).
Claim(s) 18-22 is/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).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL A. ICET whose telephone number is (571)272-0488. The examiner can normally be reached M-F: 8:00-5:00 CT.
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, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DANIEL ICET/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771