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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/09/2026 has been entered.
Response to Amendment
This Office action is in response to the applicant’s communication filed 02/09/2026.
Status of the claims:
Claims 1 – 19 are pending in the application.
Claims 1 – 12 are withdrawn.
Claim 13 is amended.
Claim Objections
The objections to claim 13 in the previous action dated 11/07/2025 have been withdrawn in light of the Applicant’s amendments filed 02/09/2026. Specifically, the objection to claim 13 regarding the phrases “the lateral side” in line 13 and “a lateral side” in line 16, has been withdrawn as the appropriate corrections have been made. However, new objections have been set forth below in light of Applicant’s amendments.
Claim 13 is objected to because of the following informalities:
Claim 13 recites “the inserter device” in line 5 and “an inserter device” in line 16, although the lines are understood by the Examiner to mean “an inserter device” and “the inserter device”, respectively, as the line providing the antecedent basis for the claimed term should come before all other instances of said claimed term within the claims, the Examiner suggests the line “wherein at least one free end of plurality of braided suture strands is pre-attached to the inserter device” be positioned after the “providing an inserter device” line;
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 13 – 15 are rejected under 35 U.S.C. 103 as being unpatentable over Federspiel et al (US 2021/0068810 A1) (previously cited) and in view of Zajac et al (US 2012/0123474 A1) (previously cited).
Regarding claim 13, Federspiel discloses a method for fixing a syndesmotic injury (abstract, paragraphs [0002 – 0003], [0009 – 0010], Figs. 7 – 8) comprising:
providing a flexible fixation implant (tibia button 300A, fibula button 100A, and suture 418) (Examiner’s note: the suture is flexible as stated in paragraph [0054], thus the fixation implant is considered flexible) comprising a first suture button (tibia button 300A), a second suture button (fibula button 100A) and a flexible suture connector (suture 418) comprising a plurality of suture strands looped through the first suture button and the second suture button (paragraphs [0054], [0057], and Fig. 8) (Examiner’s note: as stated in paragraph [0054] the suture 418 comprises multiple strands);
providing an inserter device (button inserter 440) with a cannulated insertion rod (shaft 452) (Examiner’s note: the shaft 452 has a slit 502, and is thus considered to be cannulated – See paragraph [0058] and Fig. 5B) extending from a handle (handle 442) of the inserter device (paragraphs [0056 – 0059]);
wherein at least on free end of the plurality of braided suture strands (suture 418) is pre-attached to the inserter device (button inserter 440) (Examiner’s note: as shown in Fig. 4A,4B the ends of the suture 418 is attached to the suture bollard 448 of the button inserter 440 prior to insertion of the tibia button 300A. Thus, the free ends of the suture 418 is pre-attached to the button inserter 440. Additionally, it should be understood that the suture 418 is attached to the inserter prior to the completion of the surgical procedure and thus is considered ‘pre-attached’);
attaching the first suture button (tibia button 300A) to the insertion rod of the inserter device (paragraph [0064]);
inserting the first suture button (tibia button 300A) through the bone tunnel (bone hole 706) until the first suture button exits on a medial side of the tibia (paragraph [0063 – 0065] and Figs. 7 and 8);
detaching the first suture button (tibia button 300A) from the insertion rod of the inserter device (paragraph [0063 – 0065] and Fig. 8);
positioning the first suture button (tibia button 300A) to lie flat against the medial side of the tibia (paragraphs [0063 – 0065] and Fig. 8);
withdrawing the insertion rod of the inserter device from the bone tunnel (paragraphs [0064 – 0065] and Fig. 8);
placing the second suture button (fibula button 100A) to the lateral side of the fibula by applying tension to the flexible suture connector (paragraph [0065] and Fig. 8); and
tying a knot in free ends of the flexible suture connector (suture 418) to secure the second suture button against the lateral side of the fibula (Examiner’s note: as stated in paragraph [0065] the suture 418 (i.e., the flexible suture connector) is secured by a knot once the buttons are in position (i.e., positioned against the tibia and fibula)).
However, Federspiel is silent regarding (i) the flexible suture connector comprising a splice.
As to the above, Zajac teaches, in the same field of endeavor, a method for fixing a syndesmosis injury (abstract, paragraphs [0074 – 0077], and Figs. 17 – 20) comprising a flexible fixation implant (ankle repair system 100) comprising a first suture button (oblong button 20; which equates to the tibia button 300A of Federspiel) inserted through a bone tunnel to lie flat against a tibia (tibia 90), a second button (button 10; which equates to the fibula button 100A of Federspiel) placed on the lateral side of a fibula (fibula 80) (paragraphs [0076 – 0074] and Figs. 17 – 20), and a flexible suture connector (flexible material 30; which equates to the suture 418 of Federspiel) comprising a splice (splice(s) 44a/b) for the purpose of creating a self-cinching / self-locking construct that is readily adjustable (paragraphs [0008] and [0070]) and a plurality of suture strands (strands of suture material 30 – shown in Fig. 16) (paragraph [0074] and Fig. 16).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the flexible suture connector of Federspiel to incorporate a splice, based on the teachings of Zajac, for the purpose of creating a self-cinching / self-locking construct that is readily adjustable (paragraphs [0008] and [0070] – Zajac).
Alternatively, it should be understood that Federspiel and Zajac are known references in the art that teach a method of fixing a syndesmotic injury between the tibia and fibula using a first, oblong, button connected to a second, rounded, button via a flexible suture strand (abstract, paragraphs [0002 – 0003], [0009 – 0010], Figs. 7 – 8 – Federspiel ; abstract, paragraphs [0074 – 0077], and Figs. 16 – 20 – Zajac); and the Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted one flexible suture connector for another along with one aperture configuration on each button for another respective aperture configuration, and the results of the substitution would have been predictable and resulted in the modified buttons of Federspiel being able to function as intended to properly anchor the tibia to the fibula. The Examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rational B, outlined in MPEP 2143.
Regarding claim 14, as discussed above, the combination of Federspiel and Zajac teaches the method for fixing a syndesmotic injury of claim 13. Additionally, Federspiel discloses further comprising: inserting a tab (wing 306) of the first suture button (tibia button 300A) into the cannulated insertion rod (shaft 452) of the inserter device (paragraph [0058]); and pulling the suture strands (suture strands of suture 418 of Federspiel with the splice of Zajac) toward the handle (handle 442) of the inserter device (button inserter 440) (paragraph [0063]) (Examiner’s note: when the suture 418 (i.e., the suture strands) is tensioned it is pulled towards the handle).
Regarding claim 15, as discussed above, the combination of Federspiel and Zajac teaches the method for fixing a syndesmotic injury of claim 13. Additionally, Federspiel discloses further comprising: retracting the cannulated rod (shaft 452) away from the first suture button (tibia button 300A) by means situated on the handle (Examiner’s note: the surface of the handle provides a gripping surface which allows the user to grip the handle, and the user pulls the handle in the proximal direction away from the tibia button 300A (i.e., the first button) when removed, as stated in paragraph [0065]; therefore, the cannulated rod (shaft 452) is retracted away from the first suture button (tibia button 300A) via means (grip) on the handle (handle 442)) .
Claims 16 – 19 are rejected under 35 U.S.C. 103 as being unpatentable over Federspiel et al (US 2021/0068810 A1) (previously cited) in view of Zajac et al (US 2012/0123474 A1) (previously cited), as applied to claim 13 above, and further in view of Niver et al (US 2021/0068806 A1) (previously cited).
Regarding claim 16, as discussed above, the combination of Federspiel and Zajac teaches the method for fixing a syndesmotic injury of claim 13.
However, current combination of Federspiel and Zajac is silent regarding (i) wherein the first suture button comprises two apertures and the second suture button comprises at least three apertures. With respect to (i), it should be understood that the first button and second button (tibia button 300A and fibula button 100A, respectively) have apertures for which the flexible suture connector (suture 418 of Federspiel with the splice of Zajac) pass through (See Fig. 8).
As to the above, Zajac further teaches, in the same field of endeavor, wherein the first suture button (oblong button 20; which equates to the tibia button 300A of Federspiel) comprises two apertures (Fig. 16) and the second button (button 10; which equates to the fibula button 100A of Federspiel) comprises at least three apertures (Fig. 16).
Additionally, Niver teaches, in the same field of endeavor, a method of fixing a syndesmotic injury (abstract, paragraph [0034]) providing a flexible fixation implant (stabilization device 100) comprising a first button (second button 104; which equates to the oblong shaped tibia button 300A of Federspiel) for placing against the tibia (tibia 105), a second button (first button 102; which equates to the rounded shaped fibula button 100A of Federspiel) for placing against the fibula (fibula 103), and a flexible suture connector (suture 106: which equates to the suture 418 of Federspiel) connecting the first button to the second button (paragraphs [0034 – 0036] and Figs. 1 – 10); wherein the first suture button (second button 104) comprises two apertures (first and second openings 156,158) (paragraph [0042] and Figs. 9,10) and the second suture button (first button 102) comprises at least three apertures (first opening 122, second opening 124, and opening 128) (paragraph [0037] and Figs. 1 and 2).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the first button (i.e., the tibia button 300A) and the second button (i.e., the fibula button 100A) of Federspiel in view of Zajac to incorporate the same number and configuration of apertures of the corresponding buttons of Zajac based on the teachings of Niver, for the purpose of improving the tension between the first button and second button when in the deployed state (paragraph [0028] – Niver).
Moreover, it should be understood that Federspiel and Niver are known references in the art that teach a method of fixing a syndesmotic injury between the tibia and fibula using a first button oblong button connected to a second rounded button via a suture strand (abstract, paragraphs [0002 – 0003], [0009 – 0010], Figs. 7 – 8 – Federspiel ; abstract and paragraphs [0034 – 0036] and Figs. 1 – 10 – Niver); and the Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted one aperture configuration on each button for another respective aperture configuration, and the results of the substitution would have been predictable and resulted in the modified buttons of Federspiel being able to function as intended to properly anchor the tibia to the fibula. The Examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rational B, outlined in MPEP 2143.
Regarding claims 17 and 18, as discussed above, it would have been obvious to modify the first and second buttons (i.e., the tibia button 300A and fibula button 100A) of Federspiel in view of Zajac to have the apertures of the corresponding second button and first button, respectively, of Niver. Additionally, the combination teaches wherein the suture strands (suture strands of suture strand 418 of Federspiel with the splice(s) of Zajac) is passed through at least one aperture in both the first button and the second button and wherein at least one end of the flexible connector (suture strand 418 – Federspiel) extends through the second button (Examiner’s note: as shown in Fig. 8 of Federspiel, the suture strand 418 extends through an aperture of tibia button 300A and the fibula button 100A (i.e., the first and second buttons, respectively), and as stated in paragraphs [0012] and [0040] of Federspiel the suture’s 418 ends are positioned through the second button (i.e., the fibula button 100A) and knotted within opening 130. It should be understood that although the aperture configuration of Federspiel was modified to include the aperture configuration of the buttons of Niver, that the suture strand 418 would still operate in at least the same manner passing through the apertures of each of the buttons as detailed by Federspiel and as claimed. Therefore, the combination makes obvious the limitations above).
Regarding claim 19, as discussed above, it would have been obvious to modify the first and second buttons (i.e., the tibia button 300A and fibula button 100A) of Federspiel in view of Zajac to have the apertures of the corresponding second button and first button, respectively, of Niver. Additionally, Federspiel discloses further comprising: applying tension to at least one free end of the suture strand (suture strand 418 of Federspiel with the splice(s) of Zajac) until the first suture button (tibia button 300A) pivots from one position generally parallel to the bone tunnel to another position generally transverse to the bone tunnel (paragraph [0063] and Figs. 7 to 8).
Response to Arguments
Applicant’s arguments, filed 02/09/2026, with respect to the drawing objection have been fully considered and are persuasive. Therefore the drawing objection has been withdrawn.
Applicant's arguments filed 02/09/2026, with respect to Applicant’s amendments have been fully considered but they are not persuasive. More specifically, the arguments are not persuasive because the prior art teaches wherein “at least one of the ends of the plurality of free ends of the plurality of braided suture strands is pre-attached to the inserter device” as discussed in the rejection above. Furthermore, it should be understood that the phrase “pre-attached” is defined as any moment in time prior to another, such that as long as the prior art teaches wherein an end of the braided suture strands is attached to the inserter device prior to another point in time, the claim limitation is encompassed by the prior art.
Conclusion
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/Andrew Restaino/Primary Examiner, Art Unit 3771