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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/24/2026 has been entered.
Response to Amendment
This Office Action is a response to applicant’s arguments and amendment filed 08/24/2026. Claims 1 and 23-27 are amended. Claims 6-10 are cancelled. Claims 1-5 and 11-27 are currently pending, with claims 5 and 11-22 withdrawn from consideration.
The objection of claim 1 has been withdrawn due to applicant’s amendment.
The rejection of claims 1-4 and 23-27 under 35 U.S.C. 112(b) has been withdrawn due to applicant’s amendment.
Response to Arguments
Applicant’s arguments, see Remarks, filed 08/24/2026, with respect to the rejection(s) of claim(s) 1-2, 4, 23 and 25 under 35 U.S.C. 103 as being unpatentable over Stone in view of Spedden; claim 3 under 35 U.S.C. 103 as being unpatentable over Stone in view of Spedden and White; claims 24 and 26 under 35 U.S.C. 103 as being unpatentable over Stone in view of Spedden and Overes; and claim 27 under 35 U.S.C. 103 as being unpatentable over Stone in view of Spedden and Martin, have been fully considered and are persuasive, in combination with the amendments to the claims. Specifically, Stone fails to teach the interlock mechanism configured to adjust a length of a distance between the first and second anchors as claimed. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Overes in view of Spedden as discussed below.
Applicant argues Overes does not teach or suggest a first anchor, a second anchor separate from the first anchor, and an interlock mechanism separate and independent from the first and second anchors (Remarks, pgs. 9-10).
In response to applicant’s argument, it is respectfully submitted Overes is considered to teach the claim limitations of claim 1 as discussed below, including a first anchor (22a), a second anchor (22b) and an interlock mechanism (63), such that the claim limitations are considered to be met.
Claim Objections
Claim 27 is objected to because of the following informalities: In claim 27, lines 1-2, the phrase “the tightening tightening capability” includes an additional, unnecessary “tightening” term. Appropriate correction is required.
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) 1-2, 4 and 23-26 are rejected under 35 U.S.C. 103 as being unpatentable over Overes (US 2011/0270278 A1) in view of Spedden (US 2009/0318962 A1) (all references previously of record).
Regarding claim 1, Overes discloses (see abstract; paras. [0155]-[0439]; figs. 1a-48) a tethered anchor (20, para. [0250]; fig. 18a) comprising:
a first anchor (22a, para. [0250]) including a first anchor portion (28a) and a first tether portion (38a), the first tether portion being elongate (fig. 18a) and extending between a first end (first end is directly connected to 28a) and a second end (loose end of 38a), the first tether portion being formed of a flat construct (note the limitation “being formed of a flat construct” is treated as a product by process limitation, in which determination of patentability is based on the product itself; since Overes discloses a first tether portion, the limitation is considered to be met, see MPEP 2113), the first anchor portion defining a width that is greater than a width of the first tether portion (depicted in figs. 18a-b), the first anchor portion being integrally formed with the first tether portion (may be integral with first anchor body, para. [0250]) and configured to anchor to tissue at a first position (figs. 18a-b) and extending from the first end of the first tether portion (figs. 18a-b);
a second anchor (22b) separate from the first anchor (fig. 18a) and including a second anchor portion (28b, para. [0251]) and a second tether portion (38b), the second tether portion being elongate (fig. 18a) and extending between a first end (first end is directly connected to 28b) and a second end (loose end of 38b), the second anchor portion being integrally formed with the second tether portion (para. [0251]) and configured to anchor to tissue at a second position (figs. 18a-b) extending from the first end of the second tether portion (figs. 18a-b), the second position being spaced from the first position (figs. 18a-b); and
an interlock mechanism (63, para. [0254]; fig. 18c) separate and independent from the first and second anchors (can be separate from first and second anchors, para. [0254]), the interlock mechanism configured to couple the second ends of the first and second tether portions together when the first and second anchors are fully deployed so as to define a single tether (joins anchors 22, considered to define a single tether, fig. 18c), the interlock mechanism having a tightening capability configured to adjust a length of a distance between the first and second anchors after deployment of the first and second anchors (draws anchors together to approximate an anatomical defect, considered to draw anchors together via tightening/tensioning, paras. [0254] and [0261]).
However, Overes fails to disclose the flat construct being a flat film construct.
Spedden teaches (paras. [0013]-[0016], [0179] and claim 8; figs. 1 and 6), in the same field of endeavor, a tethered anchor (paras. [0054] and [0168]) comprising a tether portion (suture construct, paras. [0013]-[0016] and [0179]), the tether portion formed of a film construct (formed of film layers, para. [0179]), for the purpose of integrating and incorporating bioactive materials into the suture construct for long-term delivery, enabling medical personnel to utilize and reintroduce bioactive materials extracted from a patient to a wound or target surgical site for therapeutic purposes (abstract, paras. [0011]-[0016]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the material of actuation strand 38a of Overes to comprise a plurality of film layers, in order to provide the capability of integrating and incorporating bioactive materials into the anchor for long-term delivery, enabling medical personnel to utilize and reintroduce bioactive materials extracted from a patient to a wound or target surgical site for therapeutic purposes when desired, based on the suggestions and teachings of Spedden (abstract, paras. [0011]-[0016]).
Regarding claim 2, Overes (as modified) teaches the tethered anchor of claim 1. Overes (as modified) further teaches wherein the flat film construct comprises a plurality of layers of film material (para. [0179] of Spedden).
Regarding claim 4, Overes (as modified) teaches the tethered anchor of claim 1. Overes further discloses wherein the first tether portion and the first anchor portion have substantially the same thickness (anchor body strand 44 and actuation strand 38 may have the same size or diameter, paras. [0172] and [0235]) where the first tether portion extends from the first anchor portion (figs. 18a-b).
Regarding claim 23, Overes (as modified) teaches the tethered anchor of claim 1. Overes further discloses wherein the interlock mechanism is a clamp (77 of connector may be clip 154, considered to function as a clamp by clamping the actuation strands, para. [0280]; figs. 22a-c).
Regarding claim 24, Overes (as modified) teaches the tethered anchor of claim 1. Overes further discloses wherein the interlock mechanism is a clip (77 of connector may be a clip 154, para. [0280]; figs. 22a-c).
Regarding claim 25, Overes (as modified) teaches the tethered anchor of claim 1. Overes further discloses wherein the interlock mechanism is a lock (defines locking member 64, para. [0257]).
Regarding claim 26, Overes (as modified) teaches the tethered anchor of claim 1. Overes further discloses wherein the interlock mechanism is a latch (77 of connector can be configured as a collar, ratchet teeth of collar and strands considered to function as a latch, paras. [0291]-[0292]; figs. 25a-b).
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over Overes in view of Spedden as applied to claim 2 above, and further in view of White (US 2010/0168864 A1).
Regarding claim 3, Overes (as modified) teaches the tethered anchor of claim 2.
However, Overes (as modified) fails to specifically teach further comprising at least one radiopaque marker inserted between the plurality of layers of film material.
White teaches (para. [0164]), in the same field of endeavor, a tethered anchor (abstract) comprising a plurality of layers (articular layer 105 formed by one or more layers of material, para. [0055]), and further comprising at least one radiopaque marker (para. [0164]) inserted between the plurality of layers (embedded in layer 105, considered to encompass being inserted between layers, para. [0164]), for the purpose of augmenting the visibility of the device when implanted as viewed by X-ray and/or fluoroscopic equipment (para. [0164]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the plurality of layers of film material of Overes (as modified) to include a radiopaque marker inserted between the plurality of layers, in order to augment the visibility of the device when implanted as viewed by X-ray and/or fluoroscopic equipment when desired, based on the suggestions and teachings of White (para. [0164]).
Claim(s) 27 is rejected under 35 U.S.C. 103 as being unpatentable over Overes in view of Spedden as applied to claim 1 above, and further in view of Martin (US 2015/0066081 A1).
Regarding claim 27, Overes (as modified) teaches the tethered anchor of claim 1.
However, Overes (as modified) fails to teach wherein the tightening capability includes a screw or knob on the interlock mechanism which, when activated, is configured to bring the first anchor portion and the second anchor portion closer together.
Martin teaches (para. [0172]; figs. 20a-21), in the same field of endeavor, a tethered anchor (4001) comprising a tightening mechanism (4000) including a screw (4076), in place of alternative locking mechanisms (para. [0145]).
The substitution of one known element (the interlocking mechanism including a screw) for another (alternative locking mechanisms, para. [0145] of Martin, see different embodiments of connectors in Overes) would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, since the substitution of the interlock mechanism including a screw as taught by Martin, would have yielded predictable results, specifically, enhancing the friction effect and increasing the holding force of the tether when desired.
Overes (as modified) further teaches wherein the tightening capability includes a screw on the interlock mechanism which, when activated, is configured to bring the first anchor portion and the second anchor portion closer together (combination considered to further teach the interlock mechanism including a screw, which upon tightening would reduce the length of the first and second tether portions relative to each other, such that the screw is considered to be capable of bringing the first and second anchor portions of Overes (as modified) closer together).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2011/0060407 A1 to Ketai, disclosing first and second tethers attached via a clip (see fig. 25).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIGID K BYRD whose telephone number is (571)272-7698. The examiner can normally be reached Mon-Fri 8:00-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BRIGID K BYRD/Examiner, Art Unit 3771
Prosecution Insights