DETAILED ACTION
The following Office Action is in response to the Amendment filed on April 2, 2026. Claims 1, 2, and 5-23 are currently pending, wherein of the pending claims, claims 12-23 are currently pending.
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
Concerning the “35 USC 112 Rejections” section on page 6 of the Applicant’s Response filed on April 2, 2026, the cancellation of claim 4 has rendered the rejection of the claim under 35 U.S.C. §112(b) moot. Therefore, the rejection is withdrawn.
Response to Arguments
Concerning the “35 USC 103 Rejections” section on pages 6-9 of the Applicant’s Response filed on April 2, 2026, the applicant’s arguments have been fully considered, but they are not persuasive. The applicant argues that the Koepke reference does not teach the limitation of “wherein the proximal end of the distal anchor includes a recess with a surface positioned therein extending in a plane substantially perpendicular to the longitudinal axis, wherein the surface comprises at least two apertures configured to receive a retention suture, and wherein the retention suture is adapted to releasably couple the anchor to an insertion tool prior to deployment”, arguing that the Koepke reference does not teach the recited arrangement of proximal end recess + transverse surface + at-least-two apertures on that surface used as a retention-suture coupling interface. However, the examiner asserts that the Koepke reference teaches all of the structural elements of the claimed invention. The proximal end recess may be defined as recess 403 (See OA Figure 1 below), the transverse surface is defined by the end of said recess defined by the end surface of cavity 431 (OA Figure 1 below), the at least two apertures on the surface are defined by cavity portion 432 which specifically has two apertures 432a and 432c (See OA Figure 1 below), and wherein these apertures are capable of being used as a retention-suture coupling interface. Although the applicant may claim that it is not enough to state that the Koepke reference is capable of having a retention-suture interface, the examiner notes that the retention suture is not positively recited and the retention suture is merely functionally recited, wherein a recitation of functional language within the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the functional limitation, then it meets the claim. In the instant case, the two apertures are capable of receiving a retention suture. Thus, given the Koepke reference recites all of the structural features as discussed above, the rejection over Koepke in view of Chavan is proper. Therefore, the rejections of the claims under 35 U.S.C. §103 stand.
PNG
media_image1.png
445
376
media_image1.png
Greyscale
OA Figure 1
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.
Claim(s) 1, 4-9, and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Koepke (US 2012/0053626) in view of Chavan et al. (US 2019/0343507, hereinafter Chavan).
Concerning claims 1 and 7-8, the Koepke reference teaches an anchor assembly, comprising: a distal anchor formed of a single component (Figure 1; 100) and extending along a longitudinal axis and having a proximal end (Figure 1; 121) and a distal self-punching tip (Figure 1; 125); at least a first aperture extends through the proximal end of the distal anchor in a direction substantially parallel to the axis (Figure 12; 432a); a first suture passing aperture (Figure 1; 111) extending through the distal anchor at an angle to the longitudinal axis (90° angle) and between the proximal end and the distal self-punching tip, wherein the proximal end of the distal anchor includes a recess (Figure 12; 403) with a surface positioned therein extending a plane substantially perpendicular to the longitudinal axis (the perpendicular surface at the distal end of recess 403; See OA Figure 1 above), wherein the surface comprises at least two apertures (Figure 12; 432, 432a, 432c | See OA Figure 1 above) capable of receiving a retention suture (retention suture is not positively recited), the retention suture capable of adapting to releasably couple the anchor to an insertion tool prior to deployment, and further comprising a second suture passing aperture extending through the distal anchor between the proximal end and the distal self-punching tip (Figure 1; 113), wherein the first suture passing aperture is offset from the second suture passing aperture, but it does not specifically teach a proximal screw configured to engage or abut the proximal end of the distal anchor.
However, the Chavan reference teaches an anchor assembly similar to that of the Koepke reference, wherein the Chavan reference teaches a distal anchor (Figure 1A; 12, 13) extending along a longitudinal axis and having a proximal end (Figure 1A; proximal end of portion 13) and a distal self-punching tip (Figure 1A; self-punching tip of 12); at least a first aperture (Figure 1C; 14) extends through the proximal end of the distal anchor in a direction substantially parallel to the longitudinal axis; a first suture passing aperture (Figure 2A; 33) extending through the distal anchor at an angle to the longitudinal axis (90° angle) and between the proximal end and the distal self-punching tip; and a proximal screw configured to engage or abut the proximal end of the distal anchor (Figure 1A; 11).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the assembly of the Koepke reference include the proximal screw of the Chavan reference to allow for securing and locking a suture that passes through the distal anchor (Chavan; [¶ 0027]).
Concerning claim 5, the combination of the Koepke and Chavan references as discussed above teaches the assembly of claim 1, wherein the Chavan reference further teaches at least a distal portion of the proximal screw being configured to fit in the recess in the proximal end of the distal anchor (Chavan; Figure 1B | [¶ 0027]).
Concerning claim 6, the combination of the Koepke and Chavan references as discussed above teaches the assembly of claim 2, wherein the Chavan reference further teaches the distal anchor comprising internal threads (Chavan; Figure 5A; 17) configured to mate with external threads of the proximal screw (Chavan; [¶ 0026]).
Concerning claim 9, the combination of the Koepke and Chavan references as discussed above teaches the assembly of claim 1, wherein the Chavan reference further teaches the proximal end of the distal anchor comprising one or more wing features (See OA Figure 2 below), wherein it would be further obvious to have the proximal end of the distal anchor of the combination include the wing features of the Chavan reference to provide a recess that allows for the insertion of a tension member to be locked via the proximal screw (Chavan; [¶ 0026]).
PNG
media_image2.png
239
498
media_image2.png
Greyscale
OA Figure 2
Concerning claim 11, the combination of the Koepke and Chavan references as discussed above teaches the assembly of claim 1, wherein the Chavan reference further teaches that the distal self-punching tip of the distal anchor may be made from a different material of the proximal end of the tip ([¶ 0030; pilot tip may not be made out of same material as anchor).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the distal self-punching tip of the Koepke reference be made out of a different material and be manufactured separately from the distal anchor as in the Chavan reference given the Chavan reference teaches that such a manufacturing process is an obvious alternative to the distal self-punching tip being the same material as a single unit (Chavan; [¶ 0030]).
Claim(s) 2 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Koepke (US 2012/0053626) in view of Chavan et al. (US 2019/0343507, hereinafter Chavan) as applied to claims 1, 4-9, and 11 above, and further in view of Lahteenkorva et al. (US 2017/0095245, hereinafter Lahteenkorva).
Concerning claim 2, the combination of the Koepke and Chavan references as discussed above teaches the assembly of claim 1, but does not specifically teach one or more vents extending at least partially through the proximal screw.
However, the Lahteenkorva reference teaches an anchor assembly similar to that of the Koepke and Chavan references, wherein the Lahteenkorva reference teaches that the anchor assembly (Figure 12; 100) may include one or more vents extending at least partially through a proximal screw portion of the anchor assembly (Figure 12; 100).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the proximal screw of the Koepke and Chavan references include one or more vents extending at least partially therethrough as in the Lahteenkorva reference to decrease mass, provide openings for bone growth, enhance physiological fluid/cell flex, increase surface area to improve rates of absorption and bioactivity (e.g., osteoconductivity), and/or increase the rate of ethylene oxide sterilization by increasing the rate at which ethylene oxide diffuses post-sterilization of the anchor assembly (Lahteenkorva; [¶ 0048]).
Concerning claim 10, the combination of the Koepke and Chavan references as discussed above teaches the assembly of claim 1, but does not specifically teach the proximal screw and the distal anchor being made from different compositions or materials.
However, the Lahteenkorva reference teaches an anchor assembly similar to that of the Koepke and Chavan references, wherein the Lahteenkorva reference teaches that a distal anchor of the assembly may be made from a different material than an insert of the assembly ([¶ 0036], anchor may be formed of a Mg-ally and the insert may be made of calcium phospate).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the proximal screw and the distal anchor of the Koepke and Chavan combination be made of different materials as in the Lahteenkorva reference to regulate the rate of degradation of the different parts of the anchor assembly (Lahteenkorva; [¶ 0036]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 MARTIN TRUYEN TON whose telephone number is (571)270-5122. The examiner can normally be reached Monday - Friday; EST 10:00 AM - 6:30 PM.
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.
/MARTIN T TON/Examiner, Art Unit 3771 5/25/2026
Prosecution Insights