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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “first strand and the second strand comprise opposing ends of single, continuous strand” of claims 9, 20 must be shown or the feature(s) canceled from the claim(s). The figures show that the first and third strand can be opposing ends of a single, continuous strand, as well as the second and fourth strand can be opposing ends of a single, continuous strand. However, the figures do not show that the first and second strands can also be a single, continuous strand. Further the specification as originally filed does not support that the first and second strands can be a single, continuous strand outside of the claims as originally filed. This embodiment of the first and second strands being the same strand as well as crossing over as claimed is not shown and would not be known/inherent. Therefore the drawing objection is applicable. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-20 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 1 recites the limitation "the third anchor comprising a portion of the second strand and a third strand of the patch" in line 14. Claim 1 also states “a third strand” in lines 3-4. It is unclear if the a third strand of line 14 is the same or different strand than the third strand of lines 3-4. For examination purposes, the limitation will be interpreted to be “[[a]] the third strand” referring back to the third strand of lines 3-4.
Claim 1 recites the limitation "the second strand extending diagonally from a second location to a third location" in line 15. Claim 1 also states “a second location” and “a third location” in lines 9 and 13 respectively. It is unclear if the locations of line 15 is the same or different locations than previously claimed. For examination purposes, limitation will be interpreted to be “[[a]] the second location and [[a]] the third location” referring back to the locations of lines 9 and 13 respectively.
Claim 1 recites the limitation "the fourth anchor comprising a portion of the first strand and a fourth strand of the patch" in lines 16-17. Claim 1 also states “a fourth strand” in line 4. It is unclear if the a fourth strand of lines 16-17 is the same or different strand than the fourth strand of line 4. For examination purposes, the limitation will be interpreted to be “[[a]] the fourth strand” referring back to the third strand of line 4.
Claim 1 recites the limitation "the first strand extending diagonally from a first location to a fourth location" in lines 18-19. Claim 1 also states “a first location” and “a fourth location” in lines 8 and 16 respectively. It is unclear if the locations of lines 18-19 is the same or different locations than previously claimed. For examination purposes, limitation will be interpreted to be “[[a]] the first location and [[a]] the fourth location” referring back to the locations of lines 8 and 16 respectively.
Claim 9 recites the limitation "the second strand extending diagonally from a second location to a third location" in line 14. Claim 1 also states “a second location” and “a third location” in lines 10 and 13 respectively. It is unclear if the locations of line 14 are the same or different locations previously cited. For examination purposes, the limitation will be interpreted to be “[[a]] the second location to [[a]] the third location” referring back to the locations of lines 10, 13, respectively.
Claim 9 recites the limitation "the first strand extending diagonally from a first location to a fourth location" in lines 16-17. Claim 1 also states “a first location” and “a fourth location” in lines 9 and 16 respectively. It is unclear if the locations of lines 16-17 are the same or different locations previously cited. For examination purposes, the limitation will be interpreted to be “[[a]] the first location to [[a]] the fourth location” referring back to the locations of lines 9, 16, respectively.
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.
Claims 1-3, 6-8, 10-13, 16, 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication 2017/0216016 to Sengun.
As to claim 1, Sengun discloses a method of fixating tissue to bone using a patch (paragraph 6) comprises the steps of:
providing a patch (2310’), a first anchor (2360a’, figure 32f), a second anchor (2360b’, figure 2b), a third anchor (2362a’) and a fourth anchor (2362b’), the patch including a body (body of 2310, figure 32f-h), a first strand (see annotated figure below), a second strand (see annotated figure below), a third strand (see annotated figure below), and a fourth strand (see annotated figure below), the body including a top portion and a bottom portion (see annotated figure below), the first strand and the second strand extending outwardly from a top portion of the body (see annotated figure below), the third strand and the fourth strand extending outwardly from a bottom portion of the body of the patch (see annotated figure below);
deploying the first anchor into a first hole at a first location (figure 32f, paragraph 385) and the second anchor into a second hole at a second location (figure 32f, paragraph 385);
securing the first strand of the patch into the first anchor at the first location and the second strand of the patch into the second anchor at the second location (figure 32f,g, paragraph 385, 386), the top portion of the patch is disposed over a portion of the tissue (figure 32h);
deploying the third anchor into a third hole at a third location (figure 32h, paragraph 385, 386 ), the third anchor comprising a portion of the second strand and a third strand of the patch (figure 32h, paragraph 385, 386), the second strand extending diagonally from a second location to a third location (figure 32g,h paragraph 385, 386);
deploying the fourth anchor into a fourth hole at a fourth location (figure 32h paragraph 385, 386), the fourth anchor comprising a portion of the first strand and a fourth strand of the patch (figure 32g,h), the first strand extending diagonally from a first location to a fourth location, the second strand and first strand intersect on a top surface of the body of the patch (figure 32g,h); and
positioning the bottom portion of the patch relative to the third and fourth locations, the bottom portion of the patch disposed over a portion of the bone (figure 32g,h, paragraph 385, 386).
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As to claim 2, Sengun discloses the first strand and the third strand comprise opposing ends of a first single, continuous strand, and the second strand and fourth strand comprise opposing ends of a second single, continuous strand (figure 32g, see annotated figure above, paragraph 385,386).
As to claim 3, Sengun discloses at least a portion of the first single, continuous strand extends through a first lumen (2314a) disposed on a portion of the body of the patch on a first side and at least a portion of the second single, continuous strand extends through a second lumen (2314d) disposed on a portion of the body of the patch on a second side (figure 32a, paragraph 379).
As to claim 6, Sengun discloses the first anchor and second anchor comprise a soft anchor (paragraph 169).
As to claim 7, Sengun discloses the third anchor and fourth anchor comprise a hard anchor (paragraph 169).
As to claim 8, Sengun discloses the patch comprises a coating, the coating comprises an antimicrobial coating, an anticoagulation coating, an antioxidant coating, a polymer coating, and/or any combination thereof (at least paragraph 323-326).
As to claim 10, Sengun discloses a method of fixating tissue to bone using a patch (paragraph 6) comprises the steps of:
providing a patch (2310’), a first anchor (2360a’, figure 32f), a second anchor (2360b’, figure 2b), a third anchor (2362a’) and a fourth anchor (2362b’), the patch including a body (body of 2310, figure 32f-h), a first strand (see annotated figure above), a second strand (see annotated figure above), a third strand (see annotated figure above), and a fourth strand (see annotated figure above), the body including a top portion and a bottom portion (see annotated figure above), the first strand and the second strand extending outwardly from a top portion of the body (see annotated figure above), the third strand and the fourth strand extending outwardly from a bottom portion of the body of the patch (see annotated figure above);
securing the first strand of the patch into the first anchor deployed within a first hole at a first location (figure 32g,h, paragraph 385, 386) and the second strand of the patch into the second anchor deployed with a second hole at a second location (figure 32g,h, paragraph 385, 386), the top portion of the patch is disposed over a portion of the tissue, (figure 32g,h);
securing the third strand and second strand of the patch into the third anchor deployed into a third hole at a third location, the second (figure 32g,h, paragraph 385, 386), the second strand extending diagonally from a second location to a third location (figure 32g,h);
securing the fourth strand and first strand of the patch into the fourth anchor deployed into a fourth hole at a fourth location (figure 32g,h, paragraph 385, 386), the first strand extending diagonally from a first location to a fourth location, the second strand and first strand intersect on a top surface of the body of the patch (figure 32g,h); and
positioning the bottom portion of the patch relative to the third and fourth locations, the bottom portion of the patch disposed over a portion of the bone (figure 32h, paragraph 385, 386).
As to claim 11, Sengun discloses the first anchor and second anchor comprise a soft anchor (paragraph 169).
As to claim 12, Sengun discloses the third anchor and fourth anchor comprise a hard anchor (paragraph 169).
As to claim 13, Sengun discloses the patch comprises a coating, the coating comprises an antimicrobial coating, an anticoagulation coating, an antioxidant coating, a polymer coating, and/or any combination thereof (at least paragraph 323-326).
As to claim 16, Sengun discloses the first strand and the third strand comprise opposing ends of a first single, continuous strand, and the second strand and fourth strand comprise opposing ends of a second single, continuous strand (figure 32g, see annotated figure above, paragraph 385,386).
As to claim 17, Sengun discloses at least a portion of the first single, continuous strand extends through a first lumen (2314a) disposed on a portion of the body of the patch on a first side and at least a portion of the second single, continuous strand extends through a second lumen (2314d) disposed on a portion of the body of the patch on a second side (figure 32a, paragraph 379).
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.
Claims 4, 5, 14, 15, 18, 19 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over U.S. Patent Publication 2017/0216016 to Sengun in view of U.S. Patent Publication 2009/0018655 Brunelle.
As to claim 4, 18, Sengun discloses a portion of the first single, continuous strand extends through a portion of the body of the patch on a first side in a first stitch pattern and at least a portion of the second single, continuous strand extends through portion of the body of the patch on a second side in a second stich pattern (paragraph 46, 379, 384, 390). Sengun does disclose that the suture limb is passed through the patch on either sides. Since the limb is passed through the patch, this can read on a stitch, which will have a stitch pattern. Other embodiments further highlight how a suture can be passed through, and/or stitched through the path along a first and second side. Brunelle teaches a similar device and method (using scaffolds for soft tissue repair, abstract) having a strand that extends through a portion of the body of the patch on a first side in a first stitch pattern at least a portion of the second single, continuous strand extends through portion of the body of the patch on a second side in a second stich pattern (figure 8, paragraph 73) for the purpose of attaching stiches to a scaffold in a way that can also reinforce the edges of the patches. If it would not be known that Sengun would read on the first and second stich patterns, it would have been obvious to use the first and second stich patterns of the first and second single, continuous strands of Brunelle in order for attaching stiches to a scaffold in a way that can also reinforce the edges of the patches.
As to claim 5, 19, with the method of Sengun and Brunelle above, Sengun discloses the first and second stich pattern comprise at least one locking stich and at least one straight stich (2212 paragraph 188, 376,377, Sengun discloses loops at the end of the patch that can read on the locking stich, and the threading of the stich through the patch can be the straight which, the locking stiches can be used in the embodiment of the straight stich in figure 32f-h). Additionally/alternatively, Brunelle also teaches the first and second stich pattern comprise at least one locking stich and at least one straight stich (paragraph 73).
As to claim 14, Sengun discloses each of the first strand, second strand, third strand, and fourth strand, comprise a flat-to-round strand (paragraph 177). The suture can have a cannulation and/or be used with a suture tape. The application as originally filed does not define the scope of a flat-to round strand. Therefore the fact that a suture with a diameter can have a cannulation, be a suture tape, or be used with a suture tape, the suture can have a flat aspect and a round aspect. This will read on the flat-to-round strand. If it would not be known that the strands of the embodiment of figure 32g-h can have a flat-to-round aspect, it would have been obvious in order to use any known type of suture strand which can help attach the patch to tissue.
Additionally/alternatively, Brunelle teaches a similar device and method (using scaffolds for soft tissue repair, abstract) having a strands that comprise a flat-to-round strand (figure 9a-d, paragraph 74-76) for the purpose of reinforcing the suture. It would have been obvious to one of ordinary skill in the art before the effective filing date to use flat-to-round sutures in the embodiment of Sengun in order for reinforcing the suture.
As to claim 15, Sengun discloses each of the first strand, second strand, third strand, and fourth strand, comprise a round strand (paragraph 177). The suture can have a size that can read on a diameter which would read on a round suture. If it would not be known that the suture of the embodiment of figure 32f-h can be round, it would have been obvious in order to use any known type of suture which can help attach the patch to tissue.
Additionally/alternatively, Brunelle teaches a similar device and method (using scaffolds for soft tissue repair, abstract) having a strands that comprise a round strand (paragraph 52-54) for the purpose of using a known type of suture that can be used to secure tissue. Brunelle teaches that the elongate members can be a round suture. It would have been obvious to one of ordinary skill in the art before the effective filing date to use a round suture for the strands in the embodiment of Sengun in order for using a known type of suture that can be used to secure tissue.
Claims 9, 20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2017/0216016 to Sengun in view of U.S. Patent Publication 2012/0130422 to Hootstein.
As to claims 9, 20, Sengun teaches the method above, but is silent about the first strand and the second strand comprise opposing ends of single, continuous strand.
Hootstein teaches a similar device and method (suture systems, abstract) having a first strand and a second strand comprising opposing ends of a single, continuous strand (paragraph 28, 29) for the purpose of interweaving sutures for help in spanning the gaps between anchors. Sengun does teach multiple other embodiments where suture can span between the first and second anchors as well as having the diagonal intersection (for instance figure 9). The application as originally filed does not support how exactly the first strand and second strand will comprise opposing ends of a single, continuous strand while having the first strand and second strand also intersect. The splicing of the sutures as taught by Hootstein will create one continuous, single strand of suture since it is continuous, and there will be a strand that will extend between the first two anchors. These strands will then be able to function as the first and second strands of Segun. Having the first and seconds strands be a continuous single strand can help bridge and the support the gap between the first two anchors. It would have been obvious to one of ordinary skill in the art before the effective filing date have the first strand and the seconds strand comprising opposing ends of a single, continuous strand in order for spanning the gaps between the first and second anchors.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent 5,441,508 to Gazielly, U.S. Patent 6,645,211 to Magana, U.S. Patent 10,292,696 to Feezor, U.S. Patent 10,675,016 to Coleman, U.S. Patent Publication 2006/0252980 to Arnal, U.S. Patent Publication 2006/0029633 to Kaiser, U.S. Patent Publication 2007/0191849 to ElAttrache, U.S. Patent Publication 2007/0288023 to Pellegrino, U.S. Patent Publication 2010/0106254 to DelSignore and U.S. Patent Publication 2010/0324608 to Albertorio all disclose similar method capable of disclosing, rendering obvious, and/or providing evidence on the claims of record.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER J ORKIN whose telephone number is (571)270-7412. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771