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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/23/25 has been entered.
Response to Amendment
The Amendment filed 12/23/25 has been entered. Claims 2 and 11 are amended. Claims 2- 19 are being addressed by this Action.
Response to Arguments
Applicant’s arguments, see Remarks, filed 12/23/25, with respect to the rejection(s) of claim(s) 2- 10 under 35 U.S.C. 102(a)(1) as being anticipated by Denham ‘418 have been fully considered and are persuasive because Denham ‘418 does not disclose the newly added limitation regarding wherein the first arm and the second arm each comprise a most distal end that faces the first direction. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Alexander (US Pub. No. 2009/0248028 A1). It is noted that applicant’s argument directed against Denham ‘418 regarding the wherein the first arm and the second arm each comprise a most distal end that faces the first direction feature for which new reference Alexander is relied.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 110a, 102, 110b that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 2- 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Alexander (US Pub. No. 2009/0248028 A1).
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Regarding claim 2, Alexander discloses a fixation device, comprising:
an elongated member having a central longitudinal axis (“A”) and comprising a first arm (112a) and a second arm (112b), wherein the first arm (112a) and the second arm (112b) have a portion that extends in a first direction (D1);
a bridge (110a, 102, 110b) in communication with the elongated member along the central longitudinal axis (“A”) and positioned between the first arm (112a) and the second arm (112b); and
a first aperture (114a) and a second aperture (114b), wherein the first aperture (114a) defines a cavity between the first arm (112a) and the bridge (110a, 102, 110b) and the second aperture (112b) defines a cavity between the second arm (114b) and the bridge (110a, 102, 110b);
wherein the first aperture (114a) and the second aperture (114b) comprise an opening (118a, 118b) extending in the first direction (D1); and
wherein the first arm (112a) and the second arm (112b) each comprise a most distal end (M1, M2) that faces the first direction (D1).
Regarding claim 3, Alexander further discloses wherein the first and second apertures (114a, 114b) further comprise a first segment (S1) having a first length (L1) and a first width (W1) and a second segment (S2) having a second length (L2) and a second width (W2) (See Annotated Fig. 3 - - Annotations for First Segment (S1) and Second Segment (S2) are separated between identical apertures (114a, 114b) for ease of viewing annotations, but it is noted that each aperture 114a and 114b have both a First Segment and a Second Segment).
Regarding claim 4, Alexander further discloses wherein the first segment (S1) and the second segment (S2) are in communication with each other (See Annotated Fig. 3 - - Annotations for First Segment (S1) and Second Segment (S2) are separated between identical apertures (114a, 114b) for ease of viewing annotations, but it is noted that each aperture 114a and 114b have both a First Segment and a Second Segment).
Regarding claim 5, Alexander further discloses wherein the first length (L1) of the first segment (S1) is greater than the second length (L2) of the second segment (S2).
Regarding claim 6, Alexander further discloses wherein the first width (W1) of the first segment (S1) is less than the second width (W2) of the second segment (S2).
Regarding claim 7, Alexander further discloses wherein the fixation device is a reflection across the central longitudinal axis (“A”) (See Annotated Fig. 3).
Regarding claim 8, Alexander further discloses wherein the bridge (110a, 102, 110b) further comprises a recessed section (106) positioned along the central longitudinal axis (“A”) and proximally to the elongated member (Ps. [0026], [0030] - - channel 106; FIGS. 1, openings 114 could be situated at about a 45-degree angle relative to the surface or cross plane of system 100; it is noted that the angled openings are interpreted as recessed portion of 110a, 110b portions of the bridge (110a, 102, 110b); it is noted that at least the threads of channel 106 are broadly interpreted as recessed).
Regarding claim 9, Alexander further discloses wherein the bridge (110a, 102, 110b) further comprises a body portion (102) positioned along the central longitudinal axis (“A”) and distally to the recessed section.
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 110a, 102, 110b, 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) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alexander (US Pub. No. 2009/0248028 A1).
Regarding claim 10, Alexander discloses the apparatus of claim 2, Alexander further disclosing wherein the first and second suture openings (122a, 122b) (Figs. 1- 4, 10) are dimensioned to accept a suture (804) and or any suitable medical object (P.[0034] - - although suture openings 122 are described herein as "suture openings," suture openings 122 could be used to secure any suitable object such as, for example, a tie, anchoring system, retaining apparatus, securing mechanism, medical object, other suitable system, or any combination thereof). Additionally, Alexander further discloses that the first and second apertures (114a, 114b) are dimensioned to accept catheter (802), surgical wires, catheters, leads, and other medical objects (See Figs. 10, 11) (Ps. [0030], [0031] - - openings 114 could be configured or situated in any suitable form or structure; It should also be understood that prongs 116 could be disposed in any suitable manner relative to openings 114. It should further be understood that prongs 116 could be any suitable shape, size, or combination to retain or secure the catheter or other medical object).
The first and second apertures (114a, 114b) perform the same function of securing any suitable object such as a medical object (Ps. [0030], [0031]) as the first and second suture openings (122a, 122b) (P. [0034]). Thus it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute one known element (first and second apertures (114a, 114b)) for another (first and second suture openings (122a, 122b)) in order to be dimensioned to accept a suture since the substitution would have yielded predictable results, namely, securing any suitable object such as a medical object. KSR, 550 U.S. at, 82 USPQ2d at 1396.
Claim(s) 11- 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Denham et al. (US Pub. No. 2008/0312689 A1) (hereinafter “Denham ‘689”) in view of Alexander (US Pub. No. 2009/0248028 A1).
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Regarding claim 11, Denham ‘689 discloses a fixation device, comprising:
a strand of suture (22) (Figs. 1- 27, 29A- 32B) comprising a first limb (L1) and a second limb (L2) with a midpoint (M) therebetween (See Annotated Fig. 25);
a first splice (S1) positioned in the first limb (L1) and a second splice (S2) positioned in the second limb (L2),
a first free end of the first limb (24) (Figs. 1- 27, 29A- 32B) extending through the second splice (S2), forming a first loop (46) (Figs. 2A- 2B, 4A-12E, 25- 27, 30A- 30B) with a diameter (P. [0057] - - the first and second free ends of the suture are fed multiple times through splices defined within longitudinal passage 30 of the suture to form adjustable loops 46);
a second free end of the second limb (26) (Figs. 1- 27, 29A- 32B) extending through the first splice (S1), forming a second loop (46’) (Figs. 2A- 2B, 4A-12E, 25- 27, 30A- 30B) with a diameter (See Annotated Fig. 25) (P. [0057] - - the first and second free ends of the suture are fed multiple times through splices defined within longitudinal passage 30 of the suture to form adjustable loops 46); and
wherein tensioning the first free end (24) in a first direction (D1) away from the midpoint (M) reduces the diameter of the first loop (46) and tensioning the second free end (26) in a second direction (D2) away from the midpoint (M) reduces the diameter of the second loop (46’) (Ps. [0033], [0037], [0057] - - bow-tie construction forming loops 46, 46’ which can be reduced in size upon applying tension to the first and second ends 24 and 26 of the suture 22); and
a button (60) (Figs. 12A- 12E) having the first and second limbs (L1, L2) of the strand of suture (22) woven therethrough (See Fig. 12A) (Ps. [0041], [0057] - - the Fig. 25 embodiment is an alternate suture construction than used in Fig. 12A). It would be in the purview of a person having ordinary skill in the art to use alternate construction suture constructions of suture 22 forming adjustable loops 46, 46’ shown in Fig. 25 with the button (60) in Fig. 12A since it is equally as applicable to use with fixation member 60 in ACL repair and have yielded the predictable result of supporting ACL 64 within the bone tunnel (P. [0041]).
Denham ‘689 does not disclose
(claims 11- 19) the button further comprising an elongated member, central longitudinal axis, first and second arm and a bridge as claimed.
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However, Alexander teaches a fixation device (100) in the same field of endeavor (Abstract, P. [0036], [0049]) comprising
(claim 11) an elongated member having a central longitudinal axis (“A”) and comprising a first arm (112a) and a second arm (112b), wherein the first arm (112a) and the second arm (112b) have a portion that extends in a first direction (D1);
a bridge (110a, 102, 110b) in communication with the elongated member along the central longitudinal axis (“A”) and positioned between the first arm (112a) and the second arm (112b); and
a first aperture (114a) and a second aperture (114b), wherein the first aperture (114a) defines a cavity between the first arm (114a) and the bridge (110a, 102, 110b) and the second aperture (114b) defines a cavity between the second arm (114b) and the bridge (110a, 102, 110b);
wherein the first aperture (114a) and the second aperture (114b) comprise an opening (118a, 118b) extending in the first direction (D1); and
wherein the first arm (112a) and the second arm (112b) each comprise a most distal end (M1, M2) that faces the first direction (D1);
(claim 12) wherein the first and second apertures (114a, 114b) further comprise a first segment (S1) having a first length (L1) and a first width (W1) and a second segment (S2) having a second length (L2) and a second width (W2) (See Annotated Fig. 3 - - First Segment (S1) and Second Segment (S2) are separated between identical apertures (114a, 114b) for ease of viewing annotations, but it is noted that each aperture 114a and 114b have both a First Segment and a Second Segment);
(claim 13) wherein the first segment (S1) and the second segment (S2) are in communication with each other (See Annotated Fig. 3 - - First Segment (S1) and Second Segment (S2) are separated between identical apertures (114a, 114b) for ease of viewing annotations, but it is noted that each aperture 114a and 114b have both a First Segment and a Second Segment);
(claim 14) wherein the first length (L1) of the first segment (S1) is greater than the second length (L2) of the second segment (S2);
(claim 15) wherein the first width (W1) of the first segment (S1) is less than the second width (W2) of the second segment (S2);
(claim 16) wherein the fixation device is a reflection across the central longitudinal axis (“A”) (See Annotated Fig. 3);
(claim 17) wherein the bridge further comprises a recessed section positioned along the central longitudinal axis (“A”) and proximally to the elongated member (P. [0030] - - FIGS. 1, openings 114 could be situated at about a 45-degree angle relative to the surface or cross plane of system 100; it is noted that the angled openings are interpreted as recessed portion of 110a, 110b portions of the bridge (110a, 102, 110b));
(claim 18) wherein the bridge (110a, 102, 110b) further comprises a body portion positioned along the central longitudinal axis (“A”) and distally to the recessed section.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the apparatus of Denham ‘689 to include a fixation device according to the teachings of Alexander because it would allow for the securement of a medical object (Alexander - - Ps. [0030], [0031], [0034]).
Regarding claim 19, Denham ‘689 in view of Alexander discloses the apparatus of claim 11, Alexander further disclosing wherein the first and second suture openings (122a, 122b) (Figs. 1- 4, 10) are dimensioned to accept a suture (804) and or any suitable object such as, for example, a tie, anchoring system, retaining apparatus, securing mechanism, medical object, other suitable system, or any combination thereof (P.[0034] - - although suture openings 122 are described herein as "suture openings," suture openings 122 could be used to secure any suitable object such as, for example, a tie, anchoring system, retaining apparatus, securing mechanism, medical object, other suitable system, or any combination thereof). Additionally, Alexander further discloses that the first and second apertures (114a, 114b) are dimensioned to accept catheter (802) and surgical wires, catheters, leads, and other medical objects (See Figs. 10, 11) (Ps. [0030], [0031] - - openings 114 could be configured or situated in any suitable form or structure; It should also be understood that prongs 116 could be disposed in any suitable manner relative to openings 114. It should further be understood that prongs 116 could be any suitable shape, size, or combination to retain or secure the catheter or other medical object).
The first and second apertures (114a, 114b) perform the same function of securing any suitable object such as a medical object (Ps. [0030], [0031]) as the first and second suture openings (122a, 122b) (P. [0034]). Thus it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute one known element (first and second apertures (114a, 114b)) for another (first and second suture openings (122a, 122b)) in order to be dimensioned to accept a suture since the substitution would have yielded predictable results, namely, securing any suitable object such as a medical object. KSR, 550 U.S. at, 82 USPQ2d at 1396.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KANKINDI RWEGO whose telephone number is (303)297-4759. The examiner can normally be reached Monday- Friday: 10:00- 5:00 MT.
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/KANKINDI RWEGO/ Primary Examiner, Art Unit 3771