DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/12/26 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-12 and 14-20 have been considered but are moot because the new ground of rejection over Stone et al. US 2009/0306711.
Applicant argues the prior art fails to disclose wherein each of the deployment suture and the sliding suture extending at least partially through the inner channel of the flexible member. However, Stone et al. discloses various embodiments of the connector device including the sleeve flexible member having an inner channel (figures 1-13, for example), and more specifically a deployment suture and a sliding suture both at least partially extending through the inner channel of the flexible member 100 (shown in figure 1B). Examiner notes it does not require the deployment and sliding suture to be position through the same portion of the flexible member.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 11, 12, 14, 16, 17 and 18 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Stone et al. US 2009/0306711.
Regarding claim 11, Stone et al. discloses a suture anchor implantation system for securing a suture within a bore of a bone (figure 9), the implantation system comprising: an insertion tool (paragraph 0044, 270 , figure 9, 10A) comprising a solid shaft having a first end (paragraph 0044, proximal end of 270 or 300, Examiner notes discloses other inserters may be used, and further a solid shaft may be considered a shaft made of a solid material, solid being defined by dictionary.com as a shaft being firm, hard or compact in substance), a second end, and an engagement region located at the second end (figure 9, 10A, second end of 270 or 300 engaging anchor 200);
an anchor comprising an elongated body (for example, 200, 330, 340) having a channel extending laterally therethrough from a first side to a second side (for example, channel 204, figure 7 or channel 306, figure 10A, distal end of channel extending through first side, or figures 16A, 16B, 18A, channel receiving 310 and 312 on each side, figure 19C), the anchor having a longitudinal recess disposed at least partially within a proximal end thereof and configured to at least partially receive the engagement region of the second end of the solid shaft (for example, figure 9, shaft shown engaging with proximal end of anchor 200, 200d’, longitudinal recess 210, figure 7, 306 extending into lateral channel, figure 10A, 16B, 18A, 19C recess 306 along the longitudinal axis of anchor);
a fixing portion comprising a flexible member (100 or 312) configured to be at least partially received through the channel (for example, figure 10A, 12A, 16A, 16B, 18A), the flexible member configured to transition from a relaxed configuration (for example, shown in figures 10A, 12A, 16A);
a sliding suture 250 configured to pass through the stopper channel or a second channel within the elongated body (paragraph 0047, an auxiliary flexible member 250 in the form of a monofilament that may be looped around sleeve and passed through fixation member 200), the sliding suture extending at least partially through an inner channel defined through the flexible member (for example, in the fixing portion 100 as shown a connector for the present teaches as shown in figure 1B, in this embodiment, both the sliding suture 250 and the deployment suture 120 are at least partially within the inner channel of 100),
a deployment suture (120 or 310) configured to be at least partially disposed within the inner channel and form a loop about the first and second ends of the flexible member (figure 7, extends through channel 210 and within channel of 100, or figure 20, extends through channel 306 and within channel of 312; configured to form a loop such as 128 as shown in figure 9, paragraph 0040; figures 21-23; 310 extends through 344 to form a loop), such that the deployment suture is configured to transition the flexible member (100 or 312) from a relaxed configuration (figure 4, figure 19A, figure 21) to a constricted configuration (balled configuration, figure 7, paragraph 0042, figures 20, 22),
wherein the flexible member in the constricted configuration contacts an inner wall of the bore within the bone so as to secure the anchor and the sliding suture therein (for example, figures 7, 12B, 16B; paragraphs 0004, 0042, 0045, 0048, 0058, 0059; sleeve 100 o3 312 is constricted to secure the sleeve to the fixation member without typing the strand on the fixation member, sleeve is on the outer surface of the anchor to be secured within the bone bore 86, or sleeve 312 can bear upon an interior surface of bore 302 of bone 304); and wherein each of the deployment suture and the sliding suture is an elongated solid structure (solid sutures or filaments 120, 250).
Regarding claim 12, Stone et al. discloses wherein the solid shaft is configured to drive the anchor into the bore 86 (figure 9).
Regarding claim 14, Stone et al. discloses wherein the elongated body has a conical surface extending distally from a distal end of the anchor (for example, figures 10A, distal tip of anchor 300).
Regarding claim 16, Stone et al. discloses wherein a first flexible member end and a second flexible member end of the flexible member are located proximal to the anchor when disposed within the bore, thereby enabling the flexible member to transition to the constricted configuration (for example, figures 19A-C), thereby enabling the flexible member to transition to the constricted configuration, figure 19C).
Regarding claim 17, Stone et al. discloses wherein a first and a second portion of the sliding suture are disposed outside of the bore when the flexible member is in the constricted configuration within the bore (figure 9, filament 250 is outside bore, can be considered a first and second portion of the filament 250 outside of the bore shown being pulled in direction of arrow B), such that the first and second portions are configured to be coupled to a soft tissue (figure 9, soft tissue 80).
Regarding claim 18, Stone et al. discloses wherein the anchor is configured to rotate and form an angle with respect to a longitudinal axis of the bore upon being under tension in a proximal direction (anchor would be configured to rotate to at least some degree by applying tension in a proximal direction to the deployment sutures, for example, figure 9, as the suture is some embodiments is extending out of one side of the suture anchor).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-9 and 20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Stone et al. US 2009/0306711 in view of Lunn et al. US 8771315.
Regarding claims 1 and 3, Stone et al. discloses a suture anchor assembly for securing a suture within a bore of a bone (for example, paragraph 0006, figures 9, 20, 22), the suture anchor assembly comprising:
a stopper portion (for example, 200, or 340; figures 7, 20, 22) comprising an elongated body having a stopper channel (for example, 210, 306, 344, figures 7, 20, 21) extending laterally therethrough from a first side to a second side (figures 7, 20, 21);
a fixing portion comprising a flexible member (100 or 312) having a first end, a second end (each side of sleeve 100, 312, shown in fig. 19A, 21), and an outer surface defining an inner channel between the first and second ends (figures 7, inner channel 106 to receive suture 120, first and second end on each side having an opening for suture 120; or figures 19A, 21, channel of 312 to receive suture 310, first and second ends shown at openings for receiving suture), the flexible member configured to be at least partially received within the stopper channel (figure 7, paragraph 0042; figure 20, 22; may be configured to be at least partially within when adjacent opening 210, 306, 344);
a deployment suture (120 or 310) configured to be at least partially disposed within the inner channel and form a loop about the first and second ends of the flexible member (figure 7, extends through channel 210 and within channel of 100, or figure 20, extends through channel 306 and within channel of 312; configured to form a loop such as 128 as shown in figure 9, paragraph 0040; figures 21-23; 310 extends through 344 to form a loop), such that the deployment suture is configured to transition the flexible member (100 or 312) from a relaxed configuration (figure 4, figure 19A, figure 21) to a constricted configuration (balled configuration, figure 7, paragraph 0042, figures 20, 22);
a sliding suture configured to pass through the stopper channel or a second channel within the elongated body (paragraph 0047, an auxiliary flexible member 250 in the form of a monofilament that may be looped around sleeve and passed through fixation member 200), the sliding suture extending at least partially through an inner channel defined through the flexible member (for example, in the fixing portion 100 as shown a connector for the present teaches as shown in figure 1B, in this embodiment, both the sliding suture 250 and the deployment suture 120 are at least partially within the inner channel of 100),
wherein the flexible member (100, 312) in the constricted configuration contacts an inner wall of the bore within the bone so as to secure the stopper portion and the sliding suture therein (figures 7, 9, 20, 21, 23; paragraphs 0004 0042, 0045, 0048, 0058, 0059; sleeve is constricted to secure the sleeve to the fixation member without typing the strand on the fixation member, sleeve is on the outer surface of the anchor to be secured within the bone bore 86, or sleeve 312 can bear upon an interior surface of bore 302 of bone 304),
wherein each of the deployment suture and the sliding suture is an elongated solid structure (solid sutures or filaments 120, 250),
wherein a first and a second portion of the sliding suture are disposed outside of the bore when the flexible member is in the constricted configuration within the bore (figure 9, filament 250 is outside bore, can be considered a first and second portion of the filament 250 outside of the bore shown being pulled in direction of arrow B), such that the first and second portions are configured to be coupled to a soft tissue (figure 9, soft tissue 80).
Stone et al. fails to disclose the stopper portion comprising poly- ether-ether-ketone.
Lunn teaches an anchor 10 comprising a stopper portion 11 (figure 1) the stopper may comprise poly-ether-ether-ketone or any other polymer suitable (column 3, lines 27-40).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Stone et al. with a poly-ether-ether-ketone stopper, as taught by Lunn, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 2, Stone et al. discloses wherein the first and second ends of the flexible member and the loop thereabout are located proximal to the stopper portion when the stopper portion is disposed within the bore (figures 7-9, anchors secured within bone bore 86, flexible member 100 and loop 128), thereby enabling the flexible member to transition to the constricted configuration.
Regarding claim 4, Stone et al. discloses wherein the stopper portion is configured to rotate and form an angle with respect to a longitudinal axis of the bore upon being placed under tension in a proximal direction (paragraph 0060, figures 22-24, anchor 340 is configured to rotate engage the bone with application of suture 310).
Regarding claim 5, Stone et al. discloses wherein the elongated body has a conical surface extending distally thereof (figures 7, 8, 20; distal tip 202, not labeled in figure 20).
Regarding claim 6, Stone et al. discloses wherein the conical surface is blunted or a truncated conical surface (similar embodiment shown in figure 16B, having stopper portion 330, fixing portion with flexible member 312, deployment suture 310, distal end is truncated conical surface).
Regarding claim 7, Stone et al. discloses wherein the deployment suture comprises a multi- stranded braided structure (paragraph 0032, braided filaments).
Regarding claim 8, Stone et al. discloses wherein the deployment suture comprises a generally tubular non-braided structure (paragraph 0032, flat tubular structure).
Regarding claim 9, Stone et al. discloses wherein an internal surface defines a through- hole disposed through a longitudinal axis or the stopper portion (paragraph 0060, figure 23, through- hole 344).
Regarding claim 20, Stone et al. discloses a system essentially as claimed, but fails to disclose the stopper portion comprising poly- ether-ether-ketone.
However, Lunn teaches an anchor 10 comprising a stopper portion 11 (figure 1) the stopper may comprise poly-ether-ether-ketone or any other polymer suitable (column 3, lines 27-40).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Stone et al. with a poly-ether-ether-ketone stopper, as taught by Lunn, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim 10 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Stone et al. US 2009/0306711 in view of Lunn et al. US 8771315 as discussed above, and further in view of Sengun US 2013/0296934.
Regarding claim 10, Stone et al. discloses in combination wherein a portion of the deployment suture 120 is disposed within the flexible member 100 (figure 1a, 9), but fails to disclose the deployment suture is disposed in a helical or a serpentine configuration.
Sengun teaches a suture anchor (figures 4, 6) comprising a deployment suture 20 and a sliding suture 50 the deployment suture is disposed in a helical or a serpentine configuration or any number of configurations for deploying the flexible member between an unstressed and anchoring configuration (figure 6, paragraph 0059, passes through openings 416)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Stone et al. with a deployment suture in a helical or serpentine configuration, as taught by Sengun, for providing a deployment suture through the flexible member in a serpentine configuration in order to deploy the flexible member between an unstressed and anchoring configuration.
Claims 15 and 19 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Stone et al. US 2009/0306711 in view of Rice et al. US 5,217,486.
Regarding claims 15 and 19, Stone et al. in combination discloses a system essentially as disclosed comprising any variety of inserters (paragraph 0044) as discussed above, but fails to explicitly disclose wherein the solid shaft further comprises a handle extending from the first end of the solid shaft, wherein the insertion tool further comprises a cannulated shaft having a shaft bore disposed through a longitudinal axis thereof, wherein the shaft bore is configured to at least partially receive the solid shaft.
Rice et al. teaches a suture anchor and implantation system, comprising an insertion tool 202 comprising a solid shaft 226 having a first end, second end, and an engagement region located at the second end, wherein the solid shaft further comprises a handle 224 extending from the first end of the solid shaft (column 9, lines 43-60), wherein the insertion tool further comprises a cannulated shaft 204 having a shaft bore disposed through a longitudinal axis thereof (figure 3), wherein the shaft bore is configured to at least partially receive the solid shaft for inserting a suture anchor (figure 3, column 9, lines 43-60).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Stone et al. with an inserter comprises a handle extending from the first end of the solid shaft, wherein the insertion tool further comprises a cannulated shaft having a shaft bore disposed through a longitudinal axis thereof, wherein the shaft bore is configured to at least partially receive the solid shaft, as taught by Rice et al., as a known inserter tool in the art for implanting suture anchors into a bone bore.
Conclusion
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/CHRISTINA C LAUER/Examiner, Art Unit 3771
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