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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 5, 2026 has been entered.
Response to Amendment
Claims 1, 2, 4, 7-8 and 10-20 are pending in the application. Claims 11-20 are withdrawn. Claim 1 has been amended. Claims 3, 5, 6, and 9 have been cancelled. Claims 1, 2, 4, 7-8 and 10 are rejected.
Claim Rejections - 35 USC § 112
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 1, 2, 4, 7, 8, and 10 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 1 recites “wherein the tensioning limb is passed through the adjustment mechanism” in line 12 of the claim. Claim 1 also recites “wherein the tensioning limb is passed through the eye splice” in lines 9-10 of the claim. It is unclear if the recitation in line 12 is attempting to refer back to the previous recitation in lines 9-10 or is attempting to claim the tensioning limb is passed through the adjustment mechanism another time. It is noted that the specification does not have support for the tensioning limb passing through the adjustment mechanism twice. It appears that applicant forgot to remove the recitation in line 12 in light of the newly added limitations in lines 9-10. For the purposes of examination, the limitation of line 12 is being interpreted as referring back to the tensioning limb being passed through the eye splice as recited in lines 9-10. Appropriate action is required.
Claim 2 recites the limitation "further comprising an adjustment loop" in line 1 of the claim. It is unclear if applicant is attempting to refer back to the “adjustment loop” as recited in line 10 of claim 1 or if applicant is attempting to claim a second separate adjustment loop. It is noted the specification does not provide support for two distinct adjustment loops. For the purposes of examination, this limitation is being interpreted as referring back to the previously recited adjustment loop in claim 1.
Claim 4 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 4 recites “The system of claim 3, wherein…” in line 1 of the claim. Claim 3 has been cancelled. For the purposes of examination, claim 4 is being interpreted as depending from claim 1. Appropriate action is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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, 8, and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over applicant cited Torrie et al (US Pat. No. 7,153,312) in view of Sullivan (US PG Pub 2013/0165972).
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Regarding claim 1, Torrie teaches an anchor system (See Fig. 2I), comprising:
a first implant (18) connected to a length of suture (10), the length of suture folded such that a tensioning limb extends from the first implant and a locking limb extends from the first implant (See Fig. 2I, note both ends of the suture extend from the first implant; See also Col. 4, line 67 – Col. 5, line 32);
a second implant (16) fixed to the locking limb (See Fig. 2I);
an adjustment mechanism (slip knot 28) having a first end and a second end in the length of suture between the first implant and the second implant (See annotated Fig. 2I), wherein the first end is closer to the first implant and the second end is closer to the second implant (See annotated Fig 2I; Col. 5, lines 15-31); and
wherein the tensioning limb is passed through the adjustment mechanism (See Fig. 2I) creating an adjustment loop in the suture between the first implant and the adjustment mechanism (See Fig. 2I);
wherein the second implant is fixed to the locking limb via a pierce hitch (56) in the locking limb (See Figs. 2B-2D; Col. 4, line 66 – Col. 5, line 15); and
wherein the pierce hitch (56) is formed between the second implant and the second end of the adjustment mechanism (See Fig. 21) by inserting an end of the locking limb through a hole from a first side to a second side in the locking limb and the second implant is fixed to the locking limb by the length of suture passing through the pierce hitch (See Figs. 2A-2D and Col. 4, line 66 – Col. 5, line 15).
Torrie does not explicitly teach the adjustment mechanism is an eye splice1 formed in the length of suture. Torrie teaches the adjustment mechanism is a one way adjustable slip knot. (See Col. 5, lines 15-31)
Sullivan teaches an analogous implantable anchor system featuring first and second implants (50 & 60) connected by a one-way (self-locking) adjustable eye splice (85). (See paragraph [0031] and Fig. 1) Sullivan teaches a splice in the suture allows the system to be knotless while still allowing for adjustment of the tension and position of the two implantable anchors (See paragraph [0016]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the system as taught by Torrie to have the adjustment mechanism be an eye splice formed in the length of suture as taught by Sullivan instead of a slip knot since a person of ordinary skill in the art would have recognized the interchangeability of the element shown in the prior art (slip knot) for the corresponding element (eye splice) disclosed in the specification. (See MPEP §2183). As stated in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398,416 (2007) ("when [an application] claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result") (citing United States v. Adams, 383 U.S. 39, 50-51 (1966)). See also MPEP §2143(I)(B). It is further noted that applicant has not disclosed that having an eye splice as the adjustment mechanism solves any stated problem or is for any particular purpose. It appears the device would perform equally well with either design. Applicant’s own specification states “in other embodiments, the adjustment mechanism 108 is a sliding knot. The adjustment mechanism 108 can be any one-way adjustable locking construct.”
Regarding claim 2, modified Torrie teaches the system of claim 1 as set forth above and further teaches the adjustment loop (See annotated Fig. 2I) in the length of suture extending from the adjustment mechanism through the first implant. (See also Col. 5, lines 16-31).
Regarding claim 4, modified Torrie teaches the system of claim 1 as set forth above and further teaches eye splice is in the locking limb. (See Figs. 2A-2I; Col. 5, lines 15-31). Note that Torrie teaches the knot is in the locking limb and in order for the tensioning limb to be able to adjust the system, the eye splice would also need to be in the locking limb.
Regarding claim 8, modified Torrie teaches the system of claim 1 as set forth above and further teaches a pair of spaced, adjacent apertures in each of the first (18a, 18b) and second (16a, 16b) implants. (See Figs. 2A and 2E; Col. 4, line 66-Col. 5, line 7)
Regarding claim 10, modified Torrie teaches the system of claim 8 as set forth above and further teaches the length of suture extends through the pair of spaced, adjacent apertures in each of the first and second implants. (See Figs. 2A-2I; Col. 4, line 66-Col. 5, line 7)
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over applicant cited Torrie et al (US Pat. No. 7,153,312) in view of Sullivan (US PG Pub 2013/0165972) as applied to claim 1 above and further in view of previously cited Collins et al (US PG Pub 2012/0290006).
Regarding claim 7, Torrie teaches the system of claim 1 as set forth above but does not explicitly teach the first implant and the second implants are rectangular2. Torrie does not explicitly describe the shape of the first and second implants, however the Figures show flat trapezoidal or generally arrow shaped implants.
Collins teaches an analogous anchoring system featuring first and second implants (300 and 400) connected by a suture with a one way adjustable mechanism (500). Collins teaches the implants may have a variety of shapes including “oval,…round, rectangular, or of any other suitable shape” (See paragraph [0012]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the system as taught by Torrie to have the first and second implants by rectangular as taught by Collins, or whatever other shape was desired or expedient. A change in shape or form is generally recognized as a matter of design choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration was significant (produced unexpected results). In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). See also MPEP §2144.04(IV)(B).
Additionally, a person of ordinary skill in the art would have recognized the interchangeability of the element shown in the prior art (trapezoidal shaped implants) for the corresponding element (rectangular implants) disclosed in the specification. (See MPEP §2183). As stated in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398,416 (2007) ("when [an application] claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result") (citing United States v. Adams, 383 U.S. 39, 50-51 (1966)). See also MPEP §2143(I)(B).
Citation of Relevant Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Lombardo et al (US PG Pub 2020/0360009) teaches an anchor system featuring an implant (100) connected to a length of suture (12) where the suture has a splice (28) in a portion of the suture which creates an adjustable loop (30).
Response to Arguments
Applicant's arguments filed January 2, 2026 have been fully considered but they are not persuasive.
Applicant argues the cited prior art references do not teach all of the limitations of claim 1. Applicant argues “none of the cited prior art references teach or suggest an external eye splice that creates a loop between the implant (and not within the implant) and the splice.”
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the eye splice being “external” and “not within the implant”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
With specific regard to applicant’s argument that the prior art does not teach “an external eye splice” it is noted that Sullivan explicitly teaches “the splice may be formed within the body or outside the body of the fixation device”. (See paragraph [0013]).
It is further noted that applicant’s own drawings clearly show the suture (106) which forms the adjustment loop (126) extends through the openings (110) in the first implant (102) and then extends towards the eye splice (108). This is the same arrangement seen in Torrie. Further Sullivan clearly shows an eye splice (85) in the suture (80) creating an adjustable loop. (See Fig. 1 provided below for applicant’s convenience).
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The remainder of applicant’s arguments amount to an allegation of patentability based on the alleged deficiencies of the primary reference. For the reasons set forth above, this is unpersuasive.
Conclusion
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/R.S.H/Examiner, Art Unit 3774
/BRIAN A DUKERT/Primary Examiner, Art Unit 3774
1 It is noted that neither the claim, nor the originally filed specification give any reason for or criticality to the adjustment mechanism being an eye splice. Additionally, Paragraph [0062] of the instant application as published states “In some embodiments, the adjustment mechanism 108 is an eye splice (i.e., finger trap), while in other embodiments, the adjustment mechanism 108 is a sliding knot. The adjustment mechanism 108 can be any one-way adjustable locking construct.”
2 It is noted that neither the claim, nor the originally filed specification give any reason for or criticality to the first and second implants being rectangular. Paragraph [0063] of the specification as published states “However, the implants 102, 104 may have any other geometric configuration”