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 Objections
Claims 1, 2, 9, and 10 objected to because of the following informalities:
Claim 1 recites “configured to insert within an opening in bone” in line 2, however this is not grammatically correct, therefore, the Examiner suggests the line be amended to read “configured to be inserted within an opening in a bone”;
Claim 2 recites “the implanted portion and the exposed portion monolithically formed” in lines 1 – 2, however this is not grammatically correct, therefore, the Examiner suggests the line be amended to read “the implanted portion and the exposed portion are monolithically formed”;
Claim 9 recites “the exposed portion and the implanted portion disposed adjacent one another” in line 2, however this is not grammatically correct, therefore, the Examiner suggests the line be amended to read “the exposed portion and the implanted portion are disposed adjacent to one another”;
Claim 10 recites “at least three times the first width” in line 1, although the line does not rise to the level of being indefinite as the line is understood by the Examiner, based on Applicant’s disclosure, to mean “at least three times greater than the first width”, the Examiner suggests the line be amended to read “at least three times greater than the first width” for the purpose of maintaining consistent language throughout the claims;
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.
Claim 13 is 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 13 recites the limitations "the distal end" in line 1 and “the proximal end” in line 2. There is insufficient antecedent basis for these limitations in the claim. Additionally, the limitations render the claim indefinite because it is unclear if Applicant is intending for claim 13 to be dependent on claim 12, which first defines the distal end as the distal end of the suture anchor and the proximal end as the proximal end of the suture anchor, or if Applicant is intending for claim 13 to be dependent on claim 11, as it is currently, and for claim 13 to define the distal end as the distal end of the suture anchor or the distal end of some other section of the suture anchor. For the purpose of examination, the Examiner will read the claim 13 to be dependent on claim 11 and for the distal end be the distal end of the suture anchor.
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.
Claims 1 – 3 and 9 – 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ken (US 2009/0062850 A1).
Regarding claims 1 – 3 and 9 – 11, Ken discloses a closure device (device 43) capable of being a suture anchor (Examiner’s note: it should be understood that a preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187F.2d 150,152,88) comprising:
an implanted portion (distal section 50 and a middle section 52) (paragraph [0051] and Fig. 3B) configured to be inserted within an opening in bone of a patient (Examiner’s note: it should be understood that the preceding limitation is functional, which requires only that the structure of the prior art be capable of functioning in the manner claimed. With that said, the distal and middle sections 50 and 52 of the device 43 is structurally capable of being inserted into a bone opening as claimed. Therefore, Ken encompasses the limitation above);
an exposed portion (proximal section 54) secured to the implanted portion (paragraph [0051] and Fig. 3B) configured to be exposed when the implanted portion is within an opening (Examiner’s note: it should be understood that the preceding limitation is functional, which requires only that the structure of the prior art be capable of functioning in the manner claimed. With that said, the proximal section 54 of the device 43 is structurally capable of being exposed when the implanted portion is placed within a bone opening as claimed. Therefore, Ken encompasses the limitation above); and
a suture (first tension member 56) laced through the exposed portion and the implanted portion (paragraph [0051] and Figs. 3A/B) such that tensioning of the suture will cause contraction of the implanted portion (distal section 50 and a middle section 52) when the implanted portion is within the opening (paragraphs [0051] and [0069]),
wherein the implanted portion (distal section 50 and a middle section 52) and the exposed portion (proximal section 54) are formed of a biocompatible matrix for promoting tissue healing (paragraph [0063]);
[claim 2] wherein the implanted portion (distal section 50 and a middle section 52) and the exposed portion (proximal section 54) are monolithically formed of bioactive polymer (synthetic collagen) (paragraph [0063]);
[claim 3] wherein the implanted portion (distal section 50 and a middle section 52) and the exposed portion (proximal section 54) are monolithically formed of allograft collagen (i.e., processed human and animal tissue) (paragraph [0063]);
[claims 9 and 10] wherein the exposed portion (proximal section 54) and the implanted portion (distal section 50 and a middle section 52) disposed adjacent one another along a first direction (longitudinal direction) (Figs. 3B), the implanted portion (distal section 50 and a middle section 52) having a first width (width of distal section 50) in a second direction perpendicular to the first direction (Fig. 3B), the exposed portion (proximal section 54) having a second width (width of proximal section 54) in the second direction that is at least 3 times greater than the first width (Fig. 3B);
[claim 11] wherein the suture (first tension member 56) includes a first leg and a second leg (see first iteration of annotated Fig. 3B), the first leg being laced through the exposed portion and the implanted portion to an apex and the second leg being laced only through the implanted portion (see first iteration of annotated Fig. 3B).
Annotated Figure 3B of Ken
(first iteration)
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Regarding claims 1 – 3, 9, 10, and 12, (alternate interpretation; changes italicized) Ken discloses a closure device (device 43) capable of being a suture anchor (Examiner’s note: it should be understood that a preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187F.2d 150,152,88) comprising:
an implanted portion (distal section 50) (paragraph [0051] and Fig. 3B) configured to insert within an opening in bone of a patient (Examiner’s note: it should be understood that the preceding limitation is functional, which requires only that the structure of the prior art be capable of functioning in the manner claimed. With that said, the distal section 50 of the device 43 is structurally capable of being inserted into a bone opening as claimed. Therefore, Ken encompasses the limitation above);
an exposed portion (proximal section 54 and a middle section 52) secured to the implanted portion (paragraph [0051] and Fig. 3B) configured to be exposed when the implanted portion is within an opening (Examiner’s note: it should be understood that the preceding limitation is functional, which requires only that the structure of the prior art be capable of functioning in the manner claimed. With that said, the proximal section 54 and middle section 52 of the device 43 are structurally capable of being exposed when the implanted portion is placed within a bone opening as claimed. Therefore, Ken encompasses the limitation above); and
a suture (first tension member 56) laced through the exposed portion and the implanted portion (paragraph [0051] and Figs. 3A/B) such that tensioning of the suture will cause contraction of the implanted portion (distal section 50) when the implanted portion is within the opening (paragraphs [0051] and [0069]),
wherein the implanted portion (distal section 50) and the exposed portion (proximal section 54 and middle section 52) are formed of a biocompatible matrix for promoting tissue healing (paragraph [0063]);
[claim 2] wherein the implanted portion (distal section 50) and the exposed portion (proximal section 54 and middle section 52) are monolithically formed of bioactive polymer (synthetic collagen) (paragraph [0063]);
[claim 3] wherein the implanted portion (distal section 50) and the exposed portion (proximal section 54 and middle section 52) are monolithically formed of allograft collagen (i.e., processed human or animal tissue used as a scaffold) (paragraph [0063]);
[claims 9 and 10] wherein the exposed portion (proximal section 54 and middle section 52) and the implanted portion (distal section 50) disposed adjacent one another along a first direction (longitudinal direction) (Figs. 3B), the implanted portion (distal section 50) having a first width (width of distal section 50) in a second direction perpendicular to the first direction (Fig. 3B), the exposed portion (proximal section 54 and middle section 52) having a second width (width of proximal section 54) in the second direction that is at least 3 times greater than the first width (Fig. 3B);
[claim 12] wherein the closure device (device 43) capable of being a suture anchor defines a proximal end defined by the exposed portion (proximal section 54 and middle section 52) and a distal end defined by the implanted portion (distal section 50) (see second iteration of annotated Fig. 3B), the exposed portion (proximal section 54 and middle section 52) being positioned between the implanted portion (distal section 50) and the proximal end, the implanted portion (distal section 50) being positioned between the distal end and the exposed portion (proximal section 54 and middle section 52) (see second iteration of annotated Fig. 3B), and the suture (first tension member 56; and designated in second iteration of Fig. 3B) includes a first leg and a second leg (see second iteration of annotated Fig. 3B), the first leg being laced through the exposed portion (proximal section 54 and middle section 52) and the implanted portion (distal section 50) to an apex and the second leg being laced from the apex through the exposed portion (proximal section 54 and middle section 52) (see second iteration of annotated Fig. 3B) only up to a position offset from the proximal end by at least 0.2 times a length of the suture anchor between the proximal end and the distal end (Examiner’s note: the offset between the proximal end and the position of the second leg on the exposed portion is greater than 20% of the total length of the suture anchor);
Annotated Figure 3B of Ken
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Claims 1, 4, 14 – 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kaiser et al (US 2011/0098727 A1).
Regarding claims 1 and 4, Kaiser discloses a suture anchor (suture construct 300) (abstract, paragraphs [0039], [0052], [0064 – 0065], and Figs. 14 and 22) comprising:
an implanted portion (flexible anchor 150 inserted into bone hole 78 – shown in Fig. 22) configured to insert within an opening in bone of a patient (Fig. 22);
an exposed portion (flexible anchor 150 on top of the labrum 18 – shown in Fig. 22) secured to the implanted portion (Figs. 14 and 22) configured to be exposed when the implanted portion is within an opening (Fig. 22); and
a suture (suture 254 which includes ends 258 and 262 – paragraph [0054]) laced through the exposed portion and the implanted portion such that tensioning of the suture will cause contraction of the implanted portion when the implanted portion is within the opening (paragraphs [0053 – 0054], [0065], and Figs. 14 and 22),
wherein the implanted portion (flexible anchor 150 inserted into bone hole 78) and the exposed portion (flexible anchor 150 on top of the labrum 18) are formed of a biocompatible matrix for promoting tissue healing (Examiner’s note: matrix is defined as a material in which something is embedded. As stated in paragraphs [0041] the flexible anchors 150 (i.e., the implanted and exposed portions) are made up of a biocompatible braid soaked in biologics; and biologics are medicines that promote healing. Therefore, the flexible anchors 150 (i.e., the implanted and exposed portions) encompass a biocompatible matrix for promoting tissue healing);
[claim 4] wherein the implanted portion (flexible anchor 150 inserted into bone hole 78) and the exposed portion (flexible anchor 150 on top of the labrum 18) are infused with one or more compounds (biologics) to promote healing (Examiner’s note: biologics are defined as medicines used for healing the body. Therefore, the biologics of Kaiser encompass compounds used to promote healing).
Regarding claim 14, Kaiser discloses a method (abstract, paragraphs [0039], [0052], [0061], [0064 – 0065], and Figs. 14 and 22) comprising:
forming an opening in a bone of a patient (paragraphs [0039] and [0061]);
inserting an implanted portion (flexible anchor 150 inserted into bone hole 78 – shown in Fig. 22) of a suture anchor (suture construct 300) into the opening (paragraphs [0061 – 0062] and Fig. 22), the suture anchor including an exposed portion (flexible anchor 150 on top of the labrum 18 – shown in Fig. 22) secured to the implanted portion (Figs. 14 and 22) and a suture (suture 254 which includes ends 258 and 262 – paragraph [0054]) laced through at least the implanted portion (Figs. 14 and 22), the exposed portion (flexible anchor 150 on top of the labrum 18) positioned external to the opening following insertion of the implanted portion into the opening (paragraph [0064 – 0065] and Fig. 22);
tensioning the suture (suture 254 which includes ends 258 and 262) such that the implanted portion wedges within the opening and resists removal from the opening (paragraph [0065] and Fig. 22); and
passing the suture (suture 254 which includes ends 258 and 262) through tissue (labrum 18) being repaired and tying the suture to secure the tissue to the suture anchor (paragraph [0065]).
Regarding claim 15, Kaiser discloses
wherein the suture (suture 254 which includes ends 258 and 262) includes a first leg (leg with end 258) laced through the exposed portion and the implanted portion to an apex (Fig. 22) (Examiner’s note: as stated in paragraph [0052] the suture forms suture loops 304/304’; and the each of the loops forms an apex within the flexible anchor(s) 150) and a second leg (leg with end 262) extending from the apex (Examiner’s note: the leg with the end 262 of the suture forms half of the apex and thus inherently extends from the apex),
wherein the method further comprising passing the second leg through the tissue and tying a portion of the second leg extending from the tissue to the first leg (paragraph [0065]) (Examiner’s note: as stated in paragraph [0065] and shown in Fig. 22, each of the ends 258 and 262 of the suture (i.e., the first and second legs) pass through the labrum (i.e., the tissue) and the suture is secured tying a knot; and the way to form a knot is to tie the two ends 258 and 262 (i.e., the first and second legs) together. Therefore, Kaiser discloses the method as claimed).
Regarding claim 16, Kaiser discloses wherein the exposed portion (flexible anchor 150 on top of the labrum 18 – shown in Fig. 22) is sized to cover the tissue (Examiner’s note: as shown in Fig. 22 the flexible anchor 150 covers a portion of the labrum (i.e., the tissue)).
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 4 is rejected under 35 U.S.C. 103 as being unpatentable over Ken (US 2009/0062850 A1) as applied to claim 1 above, and further in view of Kaiser et al (US 2011/0098727 A1).
Regarding claim 4, as discussed above, Ken discloses the device of claim 1.
However, Ken is silent regarding (i) wherein the implanted portion and the exposed portion are infused with one or more compounds to promote healing.
As to the above, Kaiser teaches, in the same field of endeavor, a suture anchor (flexible anchor 150; which equates to the entire device 43 of Ken) infused with one or more compounds (biologics) to promote healing (abstract and paragraph [0042]) for the purpose of promoting healing (Examiner’s note: biologics are defined as medicines used for healing the body. Therefore, the biologics of Kaiser encompass compounds used to promote healing).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the device of Ken to be infused / soaked with a compound (biologics), as taught by Kaiser, for the purpose of promoting healing to the vascular opening.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Ken (US 2009/0062850 A1).
Regarding claim 13, as discussed above, Ken discloses the suture anchor of claim 11. Additionally, Ken discloses wherein the apex is offset from the distal end (see second iteration of annotated Fig. 3B).
However, Ken is silent regarding (i) wherein the apex is offset from the distal end by less than 0.1 times the length of the suture anchor between the proximal end and the distal end.
As to the above, there is no evidence of record that establishes that changing the length of the offset would result in a difference in function of the device of Ken. Further, a person having ordinary skill in the art, being faced with modifying the implant, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed offset length. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the length “may” be within the claimed range, and offering other acceptable ranges (e.g., less than 0.01x, 0.02x, or 0.05x the length of the suture anchor, specification at para. [0042]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the offset between the apex and the distal end of the device of Ken to have a length less than 0.1 times the length of the device 43 (i.e., the suture anchor) as an obvious matter of design choice within the skill of the art.
Claims 5 – 6 are rejected under 35 U.S.C. 103 as being unpatentable over Kaiser et al (US 2011/0098727 A1) as applied to claim 1 above, and further in view of Troxel et al (US 9,974,534 B2).
Regarding claims 5 – 6, as discussed above, Kaiser discloses the suture anchor of claim 1.
However, Ken is silent regarding (i) [claims 5 and 6] wherein the implanted portion is infused with one or more compounds, including Bone Morphogenic Protein-2 (BMP-2), promoting bone growth.
As to the above, Troxel teaches, in the same field of endeavor, a suture anchor (flexible anchor 100) within a bone opening comprising a biocompatible matrix (abstract, col. 5 lines 9 – 36, and Figs. 1 – 3) wherein the implanted portion is infused with one or more compounds, including Bone Morphogenic Protein-2 (BMP-2), promoting bone growth (col. 6 lines 20 – 40) for the purpose of stimulating growth of the tissue (bone).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the all suture construct 300 (which includes the implanted portion) to incorporate BMP-2, as taught by Troxel, for the purpose of stimulating the growth of the tissue.
Claims 7 – 8 are rejected under 35 U.S.C. 103 as being unpatentable over Kaiser et al (US 2011/0098727 A1) as applied to claim 1 above, and further in view of Sheth et al (US 2020/0375744 A1).
Regarding claims 7 – 8, as discussed above, Kaiser discloses the suture anchor of claim 1.
However, Ken is silent regarding (i) [claims 7 and 8] wherein the exposed portion is infused with one or more growth factors, including Platelet Rich Plasma (PRP).
As to the above, Sheth teaches, in the same field of endeavor, a suture anchor (suture anchor scaffold) within a bone opening comprising a biocompatible matrix (abstract and paragraphs [0002], [0030], [0048], [0105], [0165 – 0167]) wherein the suture anchor (the suture anchor scaffold) is infused with one or more growth factors, including Platelet Rich Plasma (PRP) (paragraph [0180]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the all suture construct 300 (which includes the exposed portion) to incorporate the platelet rich plasma, as taught by Sheth, for the purpose of aiding in the healing of the tissue.
Claims 18 – 19 are rejected under 35 U.S.C. 103 as being unpatentable over Kaiser et al (US 2011/0098727 A1) as applied to claim 14 above, and further in view of Troxel et al (US 9,974,534 B2) and Sheth et al (US 2020/0375744 A1).
Regarding claims 18 – 19, as discussed above, Kaiser discloses method and suture anchor of claim 14.
However, Ken is silent regarding [claims 18 and 19] (i) wherein the implanted portion is infused with one or more compounds, including Bone Morphogenic Protein-2 (BMP-2), promoting bone growth, and (ii) wherein the exposed portion is infused with one or more growth factors, including Platelet Rich Plasma (PRP).
As to (i), Troxel teaches, in the same field of endeavor, a suture anchor (flexible anchor 100) within a bone opening comprising a biocompatible matrix (abstract, col. 5 lines 9 – 36, and Figs. 1 – 3) wherein the implanted portion is infused with one or more compounds, including Bone Morphogenic Protein-2 (BMP-2), promoting bone growth (col. 6 lines 20 – 40) for the purpose of stimulating growth of the tissue (bone).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the all suture construct 300 (which includes the implanted portion) of Kaiser to incorporate BMP-2, as taught by Troxel, for the purpose of stimulating the growth of the tissue.
As to (ii), Sheth teaches, in the same field of endeavor, a suture anchor (suture anchor scaffold) within a bone opening comprising a biocompatible matrix (abstract and paragraphs [0002], [0030], [0048], [0105], [0165 – 0167]) wherein the suture anchor (the suture anchor scaffold) is infused with one or more growth factors, including Platelet Rich Plasma (PRP) (paragraph [0180]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the all suture construct 300 (which includes the exposed portion) of Kaiser to incorporate the platelet rich plasma, as taught by Sheth, for the purpose of aiding in the healing of the tissue.
Claims 1 – 3, 14, 16 – 17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Burkhart et al (US 2013/0110165 A1) and in view of Ken (US 2009/0062850 A1).
Regarding claims 1 – 3, Burkhart discloses a suture anchor (soft anchor implant 400a) (abstract, paragraphs [0070 – 0080], and Figs. 22, 25 – 33) comprising:
an implanted portion (portion(s) of suture tape 410 buried in the bone – paragraph [0072]) configured to insert within an opening in bone of a patient (paragraphs [0070 – 0080]);
an exposed portion (portion(s) of suture tape 410 that extend over / on top of the tissue – paragraph [0072]) secured to the implanted portion (Fig. 22) configured to be exposed when the implanted portion is within an opening (paragraphs [0072 – 0078]); and
a suture (core suture(s) 420) passed through the exposed portion and the implanted portion (paragraph [0065] and Fig. 22) such that tensioning of the suture will cause contraction of the implanted when the implanted portion is within the opening (paragraphs [0075 – 0078]),
[claims 2 and 3] wherein the implanted portion (portion(s) of suture tape 410 buried in the bone) and the exposed portion (portion(s) of suture tape 410 that extend over / on top of the tissue) are monolithically formed (paragraph [0072] and Figs. 22, 25, 27).
However, Burkhart is silent regarding (i) [claim 1] wherein the suture is laced through the suture anchor, (ii) [claims 1, 2, and 3] wherein the implanted portion and the exposed portion are formed of a biocompatible matrix for promoting tissue healing and a bioactive polymer or an allograft collagen.
As to the above, discloses a closure device (device 43) capable of being a suture anchor, comprising an implanted portion (distal section 50 and a middle section 52) (paragraph [0051] and Fig. 3B) an exposed portion (proximal section 54) secured to the implanted portion (paragraph [0051] and Fig. 3B) and a suture (first tension member 56) laced through the exposed portion and the implanted portion (paragraph [0051] and Figs. 3A/B) such that tensioning of the suture will cause contraction of the implanted portion (distal section 50 and a middle section 52) when the implanted portion is within the opening (paragraphs [0051] and [0069]), wherein the implanted portion (distal section 50) and the exposed portion (proximal section 54) monolithically formed of a biocompatible matrix for promoting tissue healing (paragraph [0063]) and formed of bioactive polymer (synthetic collagen) (paragraph [0063]) or of an allograft collagen (i.e., processed human or animal tissue used as a scaffold) (mammalian tissue matrix) (paragraph [0063]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the suture anchor of Burkhart to incorporate the suture being laced through the entire anchor (i.e., both the implanted portion and the exposed portion), based on the teachings of Ken, for the purpose of increasing the amount of bunching that occurs for the implanted portion within the bone opening which helps further promote healing. Additionally, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the suture anchor (i.e., both the implanted portion and the exposed portion) of Burkhart to be formed from of a biocompatible matrix for promoting tissue healing and formed of bioactive polymer or of an allograft collagen, based on the teachings of Ken, as the above materials are known materials known to be used with implants placed in the body and for the purpose of promoting tissue healing.
Regarding claims 14 and 20, Burkhart discloses a method (abstract, paragraphs [0070 – 0080], and Figs. 22, 25 – 33) comprising:
forming an opening in a bone of a patient (Examiner’s note: as discussed in paragraphs [0072 – 0073] the suture anchor implant 400a is buried / punched through into the bone; and in order for the suture anchor implant to be placed in the bone, an opening must be formed within the bone. Therefore, Burkhart encompasses the method step of forming the opening in a bone);
inserting an implanted portion (portion(s) of suture tape 410 buried in the bone – paragraph [0072]) of a suture anchor (soft anchor implant 400a) into the opening (paragraphs [0072 – 0074] and Fig. 28), the suture anchor including an exposed portion (portion(s) of suture tape 410 that extend over / on top of the tissue – paragraph [0072]) secured to the implanted portion (Figs. 22, 25 – 33) and a suture (core suture(s) 420) passed through at least the implanted portion (paragraph [0068]), the exposed portion (portion(s) of suture tape 410 that extend over / on top of the tissue – paragraph [0072]) positioned external to the opening following insertion of the implanted portion into the opening (paragraphs [0072 – 0078] and Fig. 32);
tensioning the suture (core suture(s) 420) such that the implanted portion wedges within the opening and resists removal from the opening (paragraphs [0072 – 0078]); and
passing the suture (core suture(s) 420) through tissue being repaired (paragraph [0075]) and tying the suture to secure the tissue to the suture anchor (paragraph [0078]);
[claim 20] wherein the implanted portion (portion(s) of suture tape 410 buried in the bone) and the exposed portion (portion(s) of suture tape 410 that extend over / on top of the tissue) are monolithically formed (paragraph [0072] and Figs. 22, 25, 27).
However, Burkhart is silent regarding (i) wherein the suture is laced through the implant and (ii) [claim 20] wherein the implanted portion and the exposed portion are formed of allograft collagen.
As to the above, discloses a closure device (device 43) capable of being a suture anchor, comprising an implanted portion (distal section 50 and a middle section 52) (paragraph [0051] and Fig. 3B) an exposed portion (proximal section 54) secured to the implanted portion (paragraph [0051] and Fig. 3B) and a suture (first tension member 56) laced through the exposed portion and the implanted portion (paragraph [0051] and Figs. 3A/B) such that tensioning of the suture will cause contraction of the implanted portion (distal section 50 and a middle section 52) when the implanted portion is within the opening (paragraphs [0051] and [0069]), wherein the implanted portion (distal section 50) and the exposed portion (proximal section 54 and middle section 52) monolithically formed of a biocompatible matrix for promoting tissue healing (paragraph [0063]) and formed of bioactive polymer (synthetic collagen) (paragraph [0063]) or of an allograft collagen (i.e., processed human or animal tissue used as a scaffold) (mammalian tissue matrix) (paragraph [0063]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the suture anchor of Burkhart to incorporate the suture being laced through the entire anchor (i.e., both the implanted portion and the exposed portion), based on the teachings of Ken, for the purpose of increasing the amount of bunching that occurs for the implanted portion within the bone opening which helps further promote healing. Additionally, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the suture anchor (i.e., both the implanted portion and the exposed portion) of Burkhart to be formed from of an allograft collagen, based on the teachings of Ken, as the above material is a known material known to be used with implants placed in the body and for the purpose of promoting tissue healing.
Regarding claim 16, as discussed above, the combination of Burkhart and Ken teaches the method of claim 14. Additionally, Burkhart discloses wherein the exposed portion is sized to cover the tissue (paragraphs [0075 – 0078]).
Regarding claim 17, as discussed above, the combination of Burkhart and Ken teaches the method of claim 14. Additionally, Burkhart discloses wherein the tissue is at least one of a tendon or a ligament (tendons of the rotator cuff) (paragraphs [0072 – 0078]).
Claims 4 – 6 are rejected under 35 U.S.C. 103 as being unpatentable over Burkhart et al (US 2013/0110165 A1) and in view of Ken (US 2009/0062850 A1), as applied to claim 1 above, and further in view of Troxel et al (US 9,974,534 B2).
Regarding claims 4 – 6, as discussed above, the combination of Burkhart and Ken teaches the method of claim 1.
However, the combination of Burkhart and Ken is silent regarding [claims 4 – 6] (i) wherein the implanted portion is infused with one or more compounds, including Bone Morphogenic Protein-2 (BMP-2), promoting bone growth and healing.
As to the above, Troxel teaches, in the same field of endeavor, a suture anchor (flexible anchor 100) within a bone opening comprising a biocompatible matrix (abstract, col. 5 lines 9 – 36, and Figs. 1 – 3) wherein the implanted portion is infused with one or more compounds, including Bone Morphogenic Protein-2 (BMP-2), promoting bone growth and healing (col. 6 lines 20 – 40) for the purpose of stimulating growth of the tissue (bone) and healing of the bone / tissue.
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the suture anchor 400a of Burkart in view of Ken with one or more compounds, including to incorporate BMP-2, as taught by Troxel, for the purpose of stimulating the growth of the tissue and to promote healing of the surrounding tissue.
Claims 7 – 8 are rejected under 35 U.S.C. 103 as being unpatentable over Burkhart et al (US 2013/0110165 A1) and in view of Ken (US 2009/0062850 A1), as applied to claim 1 above, and further in view of Sheth et al (US 2020/0375744 A1).
Regarding claims 7 – 8, as discussed above, the combination of Burkhart and Ken teaches the method of claim 1.
However, the combination of Burkhart and Ken is silent regarding [claims 7 and 8] (i) wherein the exposed portion is infused with one or more growth factors, including Platelet Rich Plasma (PRP).
As to the above, Sheth teaches, in the same field of endeavor, a suture anchor (suture anchor scaffold) within a bone opening comprising a biocompatible matrix (abstract and paragraphs [0002], [0030], [0048], [0105], [0165 – 0167]) wherein the suture anchor (the suture anchor scaffold) is infused with one or more growth factors, including Platelet Rich Plasma (PRP) (paragraph [0180]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the suture anchor 400a of Burkart in view of Ken to incorporate the platelet rich plasma growth factor, as taught by Sheth, for the purpose of aiding in the healing of the tissue.
Claims 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Burkhart et al (US 2013/0110165 A1) and in view of Ken (US 2009/0062850 A1), as applied to claim 14 above, and further in view of Troxel et al (US 9,974,534 B2) and Sheth et al (US 2020/0375744 A1).
Regarding claims 18 and 19, as discussed above, the combination of Burkhart and Ken teaches the method of claim 14.
However, the combination of Burkhart and Ken is silent regarding (i) wherein the implanted portion is infused with one or more compounds, including Bone Morphogenic Protein-2 (BMP-2), promoting bone growth and (ii) the exposed portion is infused with one or more growth factors, including Platelet Rich Plasma (PRP).
As to (i), Troxel teaches, in the same field of endeavor, a suture anchor (flexible anchor 100) within a bone opening comprising a biocompatible matrix (abstract, col. 5 lines 9 – 36, and Figs. 1 – 3) wherein the implanted portion is infused with one or more compounds, including Bone Morphogenic Protein-2 (BMP-2), promoting bone growth and healing (col. 6 lines 20 – 40) for the purpose of stimulating growth of the tissue (bone) and healing of the bone / tissue.
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the suture anchor 400a of Burkart in view of Ken with one or more compounds, including to incorporate BMP-2, as taught by Troxel, for the purpose of stimulating the growth of the tissue and to promote healing of the surrounding tissue.
As to (ii), Sheth teaches, in the same field of endeavor, a suture anchor (suture anchor scaffold) within a bone opening comprising a biocompatible matrix (abstract and paragraphs [0002], [0030], [0048], [0105], [0165 – 0167]) wherein the suture anchor (the suture anchor scaffold) is infused with one or more growth factors, including Platelet Rich Plasma (PRP) (paragraph [0180]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the suture anchor 400a of Burkart in view of Ken to incorporate the platelet rich plasma growth factor, as taught by Sheth, for the purpose of aiding in the healing of the tissue.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Meister et al (US 2019/0038277 A1), Qi et al (US 2024/0099829 A1), Denham et al (US 9,357,991 B2), and Berelsman et al (US 9,918,826 B2) teach, inter alia, a suture anchor with an implanted portion and an exposed portion.
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/Andrew Restaino/Primary Examiner, Art Unit 3771