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 .
Response to Amendment
In response to the amendment filed on 10/16/2025, claims 1-13 and 19 have been canceled, and claims 14-25 and newly added claims 26-33 are pending.
Applicant’s amendments obviate the previous 35 U.S.C. 112 rejection and that rejection is hereby withdrawn.
Response to Arguments
Applicant's arguments filed 10/16/2025 have been fully considered but they are not persuasive.
With respect to independent claim 14 as amended, Applicant argues neither Hart nor Heaven et al discloses wherein the implant and the expanding cannulated fixation device are configured such that, when: i) the implant and the expanding cannulated fixation device are within a hole in a bone with the at least one repair strand engaged with the distal end section and with the at least one activation strand captured by the proximal end section; and ii) force is applied to the at least one activation strand to move the implant proximally relative to the expanding cannulated fixation device, the distal end section holds the at least one repair strand within the hole and the at least one expandable portion expands within the hole to fix the at least one repair strand between the at least one expandable portion and the bone.
Applicant argues Hart’s rivet 12 is only disclosed as holding one suture 30 at a time and that an axial force is applied by a pop rivet gun to cause proximal movement between the rivet 12 and the expansion nut 16 to expand sleeve 14 with the suture 30 extending through the interior of the sleeve 14. The Examiner does not disagree with what is disclosed in Hart. However, the Examiner respectfully disagrees with Applicant’s position that Hart does not read on the claimed limitations. Applicant is reminded, as was noted in the rejections of independent claim 14 in the Office Action dated 6/18/2025, that the at least one activation strand and the at least one repair strand are not positively recited as an element of the system. Instead, the claim uses functional language (“configured to capture”, “configured to engage”) to introduce and describe these strands. Therefore, the structure of Hart must only be capable of capturing or engaging the strands as claimed and capable of performing the function in the added “wherein” clause at the end of the claim. When inserted into a bone hole large enough to accommodate the system with the multiple strands as claimed, the system of Hart is capable of being used with both an activation strand (disposed through eyelet 28) and a repair strand (disposed around slot 34) at the same time. Since the hypothetical activation strand would be disposed through eyelet 28, much like how suture 30 is shown being disposed through eyelet 28 in Fig. 1, any proximal pulling force applied to the activation strand would transfer into a proximal pulling force applied to the implant, to thereby move the implant proximally relative to the expanding cannulated fixation device. As the expandable portions (60) of the expanding cannulated fixation device expands, it would pinch a hypothetical repair strand within the hole between the expandable portion and the bone.
Similarly, Applicant argues Heaven et al discloses sutures 550, 555 extend through the interior of spreader 1100 and the spreader 1100 is advanced into the anchor body by moving an inner tube 500 of an inserter tool 400. The Examiner does not disagree with what is disclosed in Heaven et al. However, the Examiner respectfully disagrees with Applicant’s position that Heaven et al does not read on the claimed limitations. As stated above, the at least one activation strand and the at least one repair strand are not positively recited as an element of the system. Instead, the claim uses functional language to introduce and describe these strands. Therefore, the structure of Heaven et al must only be capable of capturing or engaging the strands as claimed and capable of performing the function in the added “wherein” clause at the end of the claim. When inserted into a bone hole large enough to accommodate the system with the multiple strands as claimed, the system of Heaven is capable of being used with both an activation strand (disposed through axial bore 1125 and looped around one of channel 1127 or 1129; Fig. 11C) and a repair strand (disposed in channel 1127 or 1125) at the same time. Since the hypothetical activation strand would be disposed through axial bore 1125 and coupled to the implant via the looping around one of channel 1127 or 1129, much like how sutures 550,555 are shown being disposed through axial bore and looped around the channels in Figs. 11E and 11G, any proximal pulling force applied to the activation strand would transfer into a proximal pulling force applied to the implant, to thereby move the implant proximally relative to the expanding cannulated fixation device. As the expandable portions of the expanding cannulated fixation device expands, it would pinch a hypothetical repair strand within the hole between the expandable portion and the bone.
Therefore, Applicant’s arguments are unpersuasive and the rejection of claim 14 as being unpatentable under Hart or Heaven et al are maintained.
A positive recitation of the repair strand and the activation strand are not required until newly introduced claim 26 and claim 33. Therefore, as argued by Applicant, Hart and Heaven et al do not disclose these features and therefore claims 26-33 are indicated as allowable over the prior art.
Claim Objections
Claims 15 and 16 are objected to because of the following informalities: “The anchor assembly” in the preambles of claims 15 and 16 should instead recite - - The surgical anchor system - - to remain consistent with the amended preamble of independent claim 14. Appropriate correction is required.
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.
Claim(s) 14, 15, 18 and 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hart (US 2010/0331881).
Hart discloses the following limitations:
Claim 14. A surgical anchor (10) system, comprising:
an implant (12) comprising:
a proximal end section (18) configured to releasably engage an end of an inserter (64) (Fig. 6; [0033], [0039]), the proximal end section being configured to capture at least one activation strand (via eyelet 28; [0033]; Fig. 1; the flexible activation strands are not positively recited and since the eyelet 28 is for accommodating suture, it is also sized for and capable of receiving an activation strand),
a distal end section (20) that is configured to engage at least one repair strand (via slot 34; [0033]), and
an expander section (23) between the proximal end section and the distal end section (Figs. 1, 2; [0033], [0037]), the expander section having a substantially frusto-conical shape that tapers outwardly toward the distal end section and that defines an outer most diameter (26) of the implant (Fig. 2a; [0033]); and
an expanding cannulated fixation device (14) configured to be loaded on the inserter and to engage the implant (Fig. 6), the expanding cannulated fixation device comprising at least one expandable portion (60) that is configured to expand outwardly (Fig. 7; [0034], [0036], 0037]),
wherein the implant and the expanding cannulated fixation device are configured such that, when: i) the implant and the expanding cannulated fixation device are within a hole in a bone with the at least one repair strand engaged with the distal end section and with the at least one activation strand captured by the proximal end section (the at least one repair strand and at least one activation strand are not positively recited as an element of the system, the system of Hart is structurally capable of accepting a repair strand in slot 34 and capable of accepting an activation strand in eyelet 28 when the implant and the expanding cannulated fixation device are within a hole in a bone); and ii) force is applied to the at least one activation strand to move the implant proximally relative to the expanding cannulated fixation device, the distal end section holds the at least one repair strand within the hole and the at least one expandable portion expands within the hole to fix the at least one repair strand between the at least one expandable portion and the bone (when an activation strand is disposed through eyelet 28 and a proximal force is applied thereto, the implant is capable of pulling the implant proximally relative to the expanding cannulated fixation device, and the distal end section is capable of holding the repair strand within the hole as the expandable portion expands within the hole).
Claim 15. The surgical anchor system of claim 14, wherein the proximal end section (18) comprises an eyelet (28) capable of capturing the at least one activation strand ([0033]).
Claim 18. The surgical anchor system of claim 14, wherein the expandable cannulated fixation device defines at least one longitudinal slot (48) adjacent to the at least one expandable portion ([0034]).
Claim 21. The surgical anchor system of claim 16, wherein the at least one repair strand is suture (30) ([0033]).
Claim(s) 14, 18, 20, 22-25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Heaven et al (US 2017/0265854).
Heaven et al discloses the following limitations:
Claim 14. A surgical anchor system (Figs. 11A-11J), comprising:
an implant (1100) comprising:
a proximal end section (1110) configured to releasably engage an end of an inserter (400) ([0154]), the proximal end section being configured to capture at least one activation strand ([0154]; via axial bore 1125; Fig. 11E; the flexible activation strands are not positively recited and since the axial bore 1125 is for accommodating suture 550, it is also sized for and capable of receiving an activation strand),
a distal end section (1105) that is configured to engage at least one repair strand ([0155]; via channels 1127, 1129), and
an expander section (1108) between the proximal end section and the distal end section (Figs. 11A-11D; [0154]), the expander section having a substantially frusto-conical shape that tapers outwardly toward the distal end section and that defines an outer most diameter of the implant (at outer edge of ridge 1115) (Figs. 11B, 11C); and
an expanding cannulated fixation device (200) configured to be loaded on the inserter (400) and to engage the implant (Fig. 11J; [0153], [0162]), the expanding cannulated fixation device comprising at least one expandable portion (220) that is configured to expand outwardly (Figs. 11F-11I; [0110], [0159]),
wherein the implant and the expanding cannulated fixation device are configured such that, when: i) the implant and the expanding cannulated fixation device are within a hole in a bone with the at least one repair strand engaged with the distal end section and with the at least one activation strand captured by the proximal end section (the at least one repair strand and at least one activation strand are not positively recited as an element of the system, the system of Heaven et al is structurally capable of accepting a repair strand in via channels 1127 and 1129 and capable of accepting an activation strand via axial bore 1125 when the implant and the expanding cannulated fixation device are within a hole in a bone); and ii) force is applied to the at least one activation strand to move the implant proximally relative to the expanding cannulated fixation device, the distal end section holds the at least one repair strand within the hole and the at least one expandable portion expands within the hole to fix the at least one repair strand between the at least one expandable portion and the bone (when an activation strand is disposed through axial bore 1125 and a proximal force is applied thereto, the implant is capable of pulling the implant proximally relative to the expanding cannulated fixation device, and the distal end section is capable of holding the repair strand within the hole as the expandable portion expands within the hole).
Claim 18. The surgical anchor system of claim 14, wherein the expanding cannulated fixation device defines at least one longitudinal slot adjacent to the at least one expandable portion (Figs. 11F-11E).
Claim 20. The surgical anchor system of claim 14, wherein the expanding cannulated fixation device (200) comprises bone gripping features (230) ([0110], [0112], [0121]-[0125]).
Claim 22. A method of attaching soft tissue (2704) to bone (2706) with knotless fixation (Fig. 26B), the method comprising:
installing a first plurality of anchors (2650, 2652) in a first medial row (Fig. 26B); and
installing a second plurality of anchors (2654, 2656) in a second lateral row (Fig. 26B),
wherein at least one of the first plurality of anchors or the second plurality of anchors comprises the surgical anchor system of claim 14 ([0217]; “In one embodiment, a double-row technique such as that depicted in FIG. 26B is used wherein the medial row utilizes the anchors described herein and the lateral row utilizes suture capture anchors”).
Claim 23. A method of attaching soft tissue to bone with knotless fixation using the surgical anchor system of claim 14 (Figs. 27A-27E; [0232], [0233]; “One specific application in which the anchors described above may be utilized is a rotator cuff repair procedure, as depicted in FIGS. 27A through 27E”), the method comprising:
inserting an anchor (2700) with a length of suture (2708) attached thereto into a first hole in the bone (2706) (Fig. 27A; [0232]);
passing the suture attached to the first hole through the soft tissue (2704) (Fig. 27B; [0233]; “suture 2708 is passed over the soft tissue 2704”);
positioning the implant, with a free end of the suture threaded the distal end section (eyelet seen inside channels 1127, 1129 of the distal end section for suture to extend through and into axial bore 1125 in Figs. 11D, 11E) of the implant (implant of anchor 2710) over a second hole (hole seen occupied by anchor 2710 in Fig. 27D) in the bone and inserting the implant into the second hole in the bone ([0233]; “the suture 2708 is attached to the anchor 2710 using suture passages in the anchor body of the anchor 2710 or attaching it to the spreader”); and
installing the expanding cannulated fixation device (2710) into the second hole in the bone ([0233]), over the implant, to knotlessly secure the suture in the second hole ([0159], [0238]), such that the securing of the suture in the second hole is knotless.
Claim 24. The method of claim 23, further comprising:
retrieving the suture (2708) through a cannula (2702) after the suture is passed up through the soft tissue (from Fig. 27A to 27B, it can be seen that the removal/withdrawal of inserter 2702 results in the retrieval of the suture through the inserter after the suture is passed through tissue 2704), and
inserting, after retrieving the suture through the cannula, the end of the suture through the distal end section (from Figs. 27C to 27D, it can be seen that the end of the suture 2708 is inserted into the implant (spreader) of anchor 2710 after it has been retrieved through the cannula as earlier seen in Fig. 27B).
Claim 25. The method of claim 23, further comprising tensioning the suture ([0233]).
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.
Claim(s) 16 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hart in view of Patel et al (US 2022/0338856).
Claim 16. Hart discloses the invention substantially as claimed above, but fails to disclose the distal end section (20) comprises an eyelet for capturing the at least one repair strand. Instead, Hart discloses a slot (34) for capturing a flexible strand (Fig. 1; [0033]).
However, in the same field of endeavor of knotless suture anchors for securing soft tissue to bone, Patel et al teaches alternative designs for flexible strand engaging features may be a slot (notch), an eyelet (aperture) or a groove ([0030]). Therefore, since both Hart and Patel et al are directed to structures for engaging flexible strands at the distal end of a surgical anchor, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to substitute one known structure (slot of Hart) with another (aperture of Patel et al) to achieve the predictable result of providing a means for reliably engaging a flexible strand.
Claim 17. The combination discloses the invention substantially as claimed above, but fails to disclose a size of the eyelet in the distal end section is at least about twice a size of the eyelet in the proximal end section.
However, it would have further been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of the size of the eyelet in the distal end section to be about twice the size of the eyelet in the proximal end section 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 instant case, the device of Hart in view of Patel et al would not operate differently with the claimed dimensions since the eyelets of the prior art are both for accommodating flexible strands, like Applicant’s invention. Further, it appears that applicant places no criticality size claimed, indicating simply that “[i]n an example, the distal eyelet 122 is circular and about at least twice the size of the circular proximal eyelet 120”
Allowable Subject Matter
Claims 26-33 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art of record, Hart and Heaven et al, each discloses the invention substantially as claimed above.
The prior art of record does not disclose or fairly suggest either singly or in combination the claimed method of tissue repair with knotless fixation as recited in claim 26 or the surgical anchor system as recited in claim 33, with the at least one repair strand and the at least one activation strand as argued by Applicant in the remarks filed 10/16/2025. Therefore, in view of the prior art and its deficiencies, Applicant’s invention is rendered novel and non-obvious, and thus, is allowable as claimed.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE M SHI whose telephone number is (571)270-5620. The examiner can normally be reached Mon-Thurs, 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571)272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE M SHI/Primary Examiner, Art Unit 3771