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In response to the amendment filed on 9/12/2025, claim 1-10 are withdrawn, claims 15, 18-20 have been canceled, and claims 11-14, 16 and 17 are pending for examination.
Effective Filing Date
The instant application, filed 7/10/2023, is a continuation-in-part of U.S. Serial No. 17/454,408, filed 11/10/2021, which claims priority to U.S. Provisional Application 63/113,412, filed 11/13/2020. Claims 11-14, 16 and 17are directed to subject matter that was introduced for the first time in the instant application, filed 7/10/2023. Claims 11-14, 16 and 17are directed to the at least one suture passing loop (480, 482) and self-locking device (432) of the embodiment illustrated in Figs. 20-26, and described in published paragraphs [0123]-[0135]) The earliest disclosure for the subject matter of claims 11-14, 16 and 17 and thus the effective filing date for the subject matter of is 7/10/2023.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 11-14, 16 and 17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 11 recites “at least one free suture strand with a preformed loop on an end thereof and attached to at least one suture passing loop”. The claim appears to require two distinct loops: a preformed loop and a suture passing loop. The original disclosure fails to provide support for two distinct loops. Applicant directs the Examiner to Figs. 23-26 and pages 46-47 of the specification for support of the amended limitations. However, as described in [0127] and [0128] of the published application (which corresponds to the passages Applicant is referring to in the remarks), “a passing suture loop 480, 482 is a suture member preformed with a loop 484, 486 at a first end 488, 490” and “the loop 484 of the first passing suture loop 480 is secured to the first loop member 442 with the suture material of each loop passing through the aperture defined by the other loop”. In other words, it appears the at least one suture passing loop 480 comprises or is made up of a preformed loop 484. There is not a preformed loop attached to another distinct/separate loop (the claimed “at least one suture passing loop”). The suture passing loop 480 appears to be made up of the preformed loop 484 and the free suture strand 492. Therefore, the added limitation is considered new matter.
Claim(s) 12-14, 16 and 17 is/are rejected as being dependent on, and failing to cure the deficiencies of, their rejected respective parent claims.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 11-14, 16 and 17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 11 recites “at least one free suture strand”. The metes and bounds of the term “free” are unclear. As described in [0127] of the published application, a passing suture loop 480 Is a suture member preformed with a loop 484 at a first end 488 and a free suture strand 492 at the second end 496 thereof, wherein a passing surgical needle 500 may or may not be releasably secured at the distal end 502. It appears a “free suture strand” is a strand of suture not attached to any other sutures or anchors at this intermediate assembly of the final construct. However, in its final form, when the system is implanted into bone (see Figs. 23-26), this “free” suture strand is now attached to anchor(s) 415, therefore no longer rendering the strands as “free”. The anchors are subsequently claimed in claims 13, 14, 16 and 17 of the claims. Therefore, it is unclear what is structurally required by the suture stand to be considered a “free” suture strand.
Claim 11 recites “at least one free suture strand with a preformed loop on an end thereof and attached to at least one suture passing loop”. The claim appears to require a free suture strand and two distinct loops: a preformed loop and a suture passing loop. However, as described in [0127] and [0128] of the published application, “a passing suture loop 480, 482 is a suture member preformed with a loop 484, 486 at a first end 488, 490 and a free suture strand 492, 494 at the second end 496, 498 thereof” and “the loop 484 of the first passing suture loop 480 is secured to the first loop member 442 with the suture material of each loop passing through the aperture defined by the other loop”. In other words, it appears the at least one suture passing loop 480 comprises or is made up of a preformed loop 484 and a free suture strand. There is not a free suture strand with a preformed loop attached to another distinct loop (the claimed “at least one suture passing loop”). The suture passing loop 480 appears to be made up of the preformed loop 484 and the free suture strand 492. It is unclear how many loops claim 11 is requiring as there is no disclosure of a free suture strand with a preformed loop attached to a suture passing loop.
Claim 11 recites the limitation "the at least one passing suture strand" in lines 6-7. There is insufficient antecedent basis for this limitation in the claim. It is therefore unclear if “the preformed loop of the at least one passing suture strand” is referring to a different preformed loop (of a new element – at least one passing suture strand), or if it is referring to the preformed loop of the at least one free suture strand.
Claim 13 recites “including a bone anchor that anchors the at least one suture passing loop the area of contact”. The phrase is not grammatically correct and appears to be missing a preposition before the phrase “the area of contact”. It is unclear if claim 13 is intending to recite: to the area of contact, at the area of contact, from the area of contact, towards the area of contact, etc. For examination purposes and as best understood by the Examiner in light of the specification (and in light of the amendment to claim 14), the Examiner will interpret the limitation as - - to the area of contact - -.
Claims 13 and 14 recite “an all suture anchor that anchors the at least one suture passing loop [to] the contact area”. The claims appear to be positively reciting the area of contact as the claim necessarily requires an all suture anchor that anchors the at least one suture passing loop to the area of contact as indicated by the underlined portion above. Applicant is reminded claims 13-14 are directed to an apparatus claim, and claim limitations should only be directed to the structural features of the invention and/or its functional capabilities. The claim should not refer to actual steps performed by the anchor. As best understood by the Examiner, the contact area is an area were the anchor contacts the bone or tissue. Therefore, as presently recited and interpreted in light of the specification, claims 13-14 would still appear to be referring and positively reciting to the human body since the area of contact includes human tissue. As noted in the last Office Action dated 6/13/2025, Applicant may obviate this issue by amending the claim to recite - - is configured to anchor the at least one suture passing loop to the area of contact - -.
Claims 16 and 17 recite the limitation "the first and second suture passing loops" in line 2 of each respective claim. There is insufficient antecedent basis for this limitation in the claim. It is unclear if the at least one suture passing loop of claim 11 comprises first and second suture passing loops, or if the system comprises first and second suture passing loops in addition to the at least one passing loop of claim 11.
Claim(s) 12 is/are rejected as being dependent on, and failing to cure the deficiencies of, their rejected respective parent claims.
Response to Arguments
Applicant's arguments filed 9/12/2025 have been fully considered but they are not persuasive.
As noted above, various 35 U.S.C. 112 issues exist in the claims rendering the scope of the claim unclear thus rendering the claims unpatentable.
However, even in the absence of any 35 U.S.C. 112 issues, Applicant’s arguments directed to the preformed loop needing to remain above an area of contact to enable free movement of the at least one suture passing loop is unpersuasive. Applicant argues Norton does not show that the loops of the strand suture are free above the area of contact and therefore cannot anticipate the claims. The Examiner respectfully disagrees. The claims are directed to an apparatus claim and not a method of use. Therefore, the apparatus of Norton only needs to be capable of being used in a manner that would allow the preformed loop to remain above an area of contact to enable the claimed free movement. The user can implant the anchor into the bone to a depth that would allow the preformed loops (previously cited suture passing loops) to remain above an area of contact, thereby meeting the claimed limitations. Nonetheless, due to the 35 U.S.C. 112 issues above, Norton has not been presently applied to the claimed language since the scope of the claims cannot be ascertained.
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 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