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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 September 9th, 2025, has been entered.
Response to Amendment
The claims filed on September 9th, 2025, have been entered. Claims 1-15 and 20 remain pending in the Application. The claim amendments overcome the previous claim objections and 112(a) and 112(b) rejections.
Response to Arguments
The rejection of claims 1-15 and 20 under 102(a)(1) and 103 over Balboa et al. (Pub. No. 2020/0245997) has been withdrawn in light of Applicant’s amendment made September 9th, 2025; specifically, Balboa et al. does not teach the annular projection having an annular slot extending through an entire thickness of the radial thickness of the annular projection.
Applicant’s arguments with respect to claim(s) 1-15 and 20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 3-4, 7-13, 15, and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Housman (Pub. No. 2019/0125332).
Regarding claim 1, Housman discloses a suture anchor system (100; FIG. 1-1; [0017]) comprising:
an anchor body (112; FIG. 6-1) configured to anchor within a target tissue ([0023] 112 is capable of being anchored into tissue), the anchor body comprising;
a proximal end (FIG. 6-1: the end of prongs 612), a distal tip (604), and an outer surface extending therebetween (FIG. 6-1: an outer surface extends between 604 and the ends of 612);
an eyelet (616) extending through the anchor body ([0023] 616 extends through each 612 to go through the whole body of 112);
a cavity (FIG. 6-1: an internal cavity within 112 allows for insertion of 108) extending from the eyelet (FIG. 6-1: the cavity within 112 extends proximally from 616), axially up to and including the proximal end of the anchor body (FIG. 6-1: the cavity within 112 reaches the proximal ends of 612);
an annular projection (612) extending from the proximal end (FIG. 6-1: 612 extends to the proximal end of 112) defining an inner lumen surface that is continuous with the anchor body cavity (FIG. 6-1: the inner surface of 612 is continuous with the internal cavity within 112), the annular projection defining an outer circumferential surface (FIG. 6-1: the 612 together form an outer circumferential surface), and a radial thickness that extends from the inner lumen surface to the outer circumferential surface (FIG. 6-1: each 612 has a thickness), the annular projection having an annular slot (620) extending axially along an entire length of the annular projection (FIG. 6-1: 620 extends the length of 612) and also through an entire thickness of the radial thickness of the annular projection (FIG. 6-1: 620 extends the full thickness of 612);
a plug (108), configured to move axially along both the anchor body cavity and an annular projection lumen ([0024] 108 can move within the cavity of 112 and within 104), wherein when a suture is disposed through the eyelet, the plug is configured to move axially to knotlessly lock the suture with the anchor body ([0025] 108 is used to retain a suture threaded through 616); and
an insertion instrument (104) having a sleeve (FIG. 2-1: 104 is a sleeve) configured to house a portion of the plug ([0024] 104 is designed to hold part of 108), the sleeve having an annular tab (304; annular is being interpreted as being spaced circumferentially on the distal end of the sleeve) extending axially from a sleeve distal end (FIG. 7-1: 304 extends from the distal end of 104), wherein the annular slot is configured to receive the annular tab therein (FIG. 8-1: 620 receives 304; [0023]) to interdigitate when the insertion instrument and anchor body are linked to form an annular connecting portion (FIG. 8-1: 304 and 620 form a single tubular portion), the annular connecting portion defining an inner lumen surface and an external surface that includes both the annular projection and the annular tab (FIG. 8-1: the combination of the outer surface of 304 and the inner surface of 620 includes both 612 and 620).
Regarding claim 3, Housman further discloses the sleeve distal end includes internal threads to threadingly engage threads on the plug (FIG. 8-1: 108 engages with threads on 112).
Regarding claim 4, Housman further discloses the anchor body annular projection is absent threads ([0029] 108 can be without threads to have a linear interference fit with 104 and 112 instead).
Regarding claim 7, Housman further discloses the eyelet traverses the anchor body, defining an entrance aperture ([0023] one of the 616) and an exit aperture ([0023] the other of the 616), and wherein the exit and entrance apertures align with the annular projection (FIG. 6-1: the 616 align with the side of 612 that they are formed in).
Regarding claim 8, Housman further discloses the eyelet traverses the anchor body, defining an entrance aperture ([0023] one of the 616) and an exit aperture ([0023] the other of the 616), and wherein the exit and entrance apertures are circumferentially offset from the annular slot (FIG. 6-1: the 616 are circumferentially offset from 620).
Regarding claim 9, Housman discloses a suture anchor system (100; FIG. 1-1; [0017]) comprising:
an anchor body (112; FIG. 6-1) for anchoring within a target tissue ([0023] 112 is capable of being anchored into tissue), the anchor body comprising a proximal connecting portion (612); and
an insertion instrument (104) for inserting the anchor body within the target tissue (104), the insertion instrument having an instrument connecting portion (304) at a distal end of an insertion instrument sleeve (FIG. 7-1: 304 is at the distal end of the sleeve of 104);
wherein the anchor body connecting portion and the insertion instrument connecting portion are configured to assemble to each other such that they interdigitate to define an axially coextensive length forming a tubular connecting portion (FIG. 8-1: 104 and 112 form a single tubular portion) with a shared inner diameter along the entire axially coextensive length (FIG. 8-1: 104 and 112 share their inner diameter for the entirety of their connection).
Regarding claim 10, Houseman further discloses a plug (108), configured to move axially along a cannulation of the anchor body ([0024] 108 is moved within 104) and knotlessly lock a suture with the anchor body ([0025] 108 retains a suture without knots) and wherein the inner shared diameter of the axially overlapping length is continuous with the cannulation (FIG. 8-1: the inner diameter of 104 and 112 is continuous with the portion of 104 which 108 moves within) and is also configured to receive the plug therein (FIG. 8-1: the combined 104/112 receives 108).
Regarding claim 11, Housman further discloses the plug is configured to rotate while moving axially along the cannulation ([0024] 108 is screwed into 112, which requires rotation during axial movement) and wherein the tubular connecting portion is configured to inhibit the anchor body from rotating while rotating the plug (FIG. 8-1: the threads in 104/112 keep the device from rotating when 108 rotates).
Regarding claim 12, Housman further discloses the anchor body proximal connecting portion defines an annular projection (608) with two annular slots therethrough ([0023] 608 is made of two parallel 612) and the insertion instrument connecting portion includes two annular tabbed projections circumferentially spaced from each other ([0025] the two 304 are spaced apart), the two annular tabbed projections configured to be received by, one each, the two annular slots to define the tubular connecting portion ([0025] and FIG. 8-1: 612 move in between the spaces of 304).
Regarding claim 13, Housman further discloses the instrument connecting portion includes internal threads (FIG. 8-1: 104 has internal threads), configured to threadingly engage threads of the plug (FIG. 8-1: the threads of 104 hold the threads of 108) and the anchor body proximal connecting portion is absent threads (FIG. 8-1: the proximal portion of 104 does not have threads), so that the shared inner diameter of the tubular connecting portion includes a segment that is threaded (FIG. 8-1: the distal portion of 104 has the threads to connect with 108) and a segment that is absent threads (FIG. 8-1: the proximal portion of 104 does not have threads).
Regarding claim 15, Housman further discloses the anchor body further comprises an eyelet through the anchor body (616), having an entrance aperture ([0023] one of the 616) and an exit aperture ([0023] the other of the 616), and wherein the exit and entrance apertures are circumferentially offset from the two annular slots of the anchor body connecting portion (FIG. 6-1: both 616 are offset from 620).
Regarding claim 20, Housman discloses a suture anchor system (100; FIG. 1-1; [0017]) comprising:
an anchor body (112; FIG. 6-1) for anchoring within a target tissue ([0023] 112 is capable of being anchored into tissue), the anchor body having a first projection and a second projection ([0023] two 612s) that both extend proximally from a proximal end of the anchor body (FIG. 6-1: 612 extend to the proximal end of 112), the first and second projection each having an axial length and an inner lumen (FIG. 6-1: both 612 have lengths and define lumen), the inner lumen interrupted, to define a first and a second annular gap (FIG. 6-1: both 620s interrupt the lumen formed by 612), each of the first and second annular gap extending along an entire length of the axial lengths (FIG. 6-1: the 620s go for the whole length of the 612s);
an insertion instrument for inserting the anchor body into the target tissue (104), the insertion instrument having a first tab (FIG. 8-1: the first 304) and a second tab circumferentially spaced from the first tab by an annular gap (FIG. 8-1: the other 304, spaced apart by a gap), and wherein both the first and second tabs extend distally from a distal end of the insertion instrument (FIG. 8-1: both 304s extend to the distal end of 104);
wherein the anchor body first annular gap is configured to receive the first tab (FIG. 8-1: one 304 move into one 620) and the second annular gap is configured to receive the second tab to form a tubular connecting portion (FIG. 8-1: the second 304 moves into the second 620).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 6 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Housman.
Regarding claim 6, Housman discloses the invention as claimed in claim 1, as discussed above, and further discloses the annular projection defines a first annular segment length (FIG. 8-1: 112 has a first circumferential length), and the annular tab defines a second annular segment length (FIG. 8-1: 304 has a circumferential length). Housman does not explicitly disclose the first annular segment length is at least double that of the second annular segment length. However, as shown in FIG. 8-1, the length of 112 appears to be at least double the length of 304.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have made the first annular segment length at least double that of the second annular segment length, as Housman illustrates approximately that ratio. Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the ratio to be double, since it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device." Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert denied, 469 U.S. 830, 225 SPQ 232 (1984). In the present case, the device in Housman would not operate differently with the claimed ratio.
Regarding claim 14, Housman discloses the invention as claimed in claim 9, as discussed above, and further discloses the anchor body connecting portion defines a first circumferential segment length of the tubular connecting portion (FIG. 8-1: 112 has a first circumferential length) and the instrument connecting portion defines a second circumferential segment length of the tubular connecting portion (FIG. 8-1: 304 has a circumferential length). Housman does not explicitly disclose the first circumferential segment length is greater than the second circumferential segment length. However, as shown in FIG. 8-1, the length of 112 appears to be at least double the length of 304.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have made the first annular segment length at least double that of the second annular segment length, as Housman illustrates approximately that ratio. Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the ratio to be double, since it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device." Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert denied, 469 U.S. 830, 225 SPQ 232 (1984). In the present case, the device in Housman would not operate differently with the claimed ratio.
Claim(s) 2 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Housman in view of Balboa et al. (Pub. No. 2020/0245997).
Regarding claim 2, Housman discloses the invention as claimed in claim 1, as discussed above. Housman does not disclose the annular tab has a threaded inner surface coextensive with the annular projection, the threaded inner surface for threadingly engaging external threads on the plug.
Balboa et al. discloses an anchor (11) comprising an annular projection (11c) comprising a threaded inner surface ([0025] 11c has threads to engage 12; FIG. 1), a plug (12) comprising external threads (12a’), and an insertion instrument (20; FIGs. 3-4) comprising an annular tab (24) comprising a threaded inner surface (29; [0028]) coextensive with the annular projection (FIG. 4: 24 is coextensive with 11), for the purpose of allowing for axial movement of the driver to transfer the plug from being within the insertion instrument to being within the anchor to retain the suture threaded through the anchor ([0023-28]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the inner surface of the annular tab of Housman to be threaded and engage the plug, as taught by Balboa et al., for the purpose of allowing for axial movement of the driver to transfer the plug from being within the insertion instrument to being within the anchor to retain the suture threaded through the anchor.
Regarding claim 5, Housman discloses the invention as claimed in claim 1, as discussed above, and further discloses the plug includes a threaded outer surface ([0023] 108 has a threaded outer surface) and the annular connecting portion has an inner lumen surface that includes a circumferential segment that is threaded (FIG. 8-1: a distal part of the inner surface of 104 has threads to connect with 108) and a circumferential segment that is not threaded (FIG. 8-1: a proximal part of the inner surface of 104 is not threaded). Housman does not disclose an inner lumen surface of the annular tab is threaded to threadedly engage the plug threaded outer surface.
Balboa et al. discloses an anchor (11) comprising an annular projection (11c) comprising a threaded inner surface ([0025] 11c has threads to engage 12; FIG. 1), a plug (12) comprising external threads (12a’), and an insertion instrument (20; FIGs. 3-4) comprising an annular tab (24) comprising a threaded inner surface (29; [0028]) coextensive with the annular projection (FIG. 4: 24 is coextensive with 11), for the purpose of allowing for axial movement of the driver to transfer the plug from being within the insertion instrument to being within the anchor to retain the suture threaded through the anchor ([0023-28]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the inner surface of the annular tab of Housman to be threaded and engage the plug, as taught by Balboa et al., for the purpose of allowing for axial movement of the driver to transfer the plug from being within the insertion instrument to being within the anchor to retain the suture threaded through the anchor.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES RYAN MCGINNITY whose telephone number is (571)272-0573. The examiner can normally be reached M-Th 8 am-5:30 pm.
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/JRM/Examiner, Art Unit 3771
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771