DETAILED ACTION
The following Office Action is in response to the Response to Restriction filed on April 11, 2026. Claims 1-15 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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on April 11, 2026 is acknowledged.
Claim 15 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on April 11, 2026.
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 § 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 1-10 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.
Concerning claim 1, line 8 of the claim recites the limitation of “the one or more saddles”. There is a lack of antecedent basis for this limitation in the claim. For the purposes of compact prosecution, the limitation will be interpreted as reading “one or more saddles”.
Line 7 of the claim recites the limitation of “the openings”. However, the claim previously recites “one or more openings”, therein making the scope of the claim indefinite as to whether it may include a single opening or if it must include a plurality of openings. For the purposes of compact prosecution, the limitation will be interpreted as “the one or more openings”.
Concerning claim 3, line 3 of the claim recites the limitation of “the opening”. However, there is an opening associated with the pocket as well as one or more openings associated with at least one of the first or second branch, therein making the limitation indefinite. For the purposes of compact prosecution, the limitation of “the opening” will be interpreted as reading “the opening of the pocket”.
Concerning claim 7, line 1 of the claim recites the limitation of “one or more saddles”, wherein the limitation is not preceded by an article, therein making it indefinite as to whether the limitation refers to “the one or more saddles” of claim 1 or if they are a separate set of “one or more saddles”. For the purposes of compact prosecution, the limitation will be interpreted as reading “the one or more saddles”.
Claims 2-10 are further rejected for being dependent on an indefinite claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 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) 1-4, 6, and 10-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schwartz et al. (US 2001/00089721, hereinafter Schwartz).
Concerning claim 1, the Schwartz et al. prior art reference teaches a fixation system for knotlessly stabilizing anatomical structures (Figures 1-8), the system comprising: a clamp (Figures 5 & 6; 20) comprising: a first branch (Figure 5; 26) and a second branch (Figure 5; 28), the first branch and the second branch adapted to move towards each other to close the clamp (Figure 6); one or more openings at a distal end of at least one of the first or second branch (Figure 5; 22), the one or more openings adapted for a flexible member to be passed through (Figure 5; 40), wherein said flexible member is capable of forming two or more loops around one or more saddles and a distal button (saddles and distal button not positively recited, and flexible member is merely functionally recited, thus it must simply be capable of forming two loops around one or more saddle structures or a distal button); a first protuberance at a proximal end of the first branch; a second protuberance at a proximal end of the second branch (Figure 5; tips 29 of branches 26 and 28 = protuberances); and a first jaw on the first protuberance and a second jaw of the second protuberance (Figure 5; surface of branches 26 and 28 defining teeth 32 = jaws), the first and second jaws defining a clamping area (Figure 5; 30), the first and jaws adapted for clamping and knotlessly securing the flexible member within the clamping area between the jaws (Figure 6).
Concerning claim 2, the Schwartz reference teaches the fixation system of claim 1, wherein the clamp further comprises a force receiving area on each of the protuberances (Figure 5; outer surface of tip 29 = force receiving area), the force receiving areas laterally distant from a distal-proximal central axis of the clamp, the force receiving areas adapted to receive contact force, thereby urging the first branch and the second branch towards each other (Figure 6).
Concerning claim 3, the Schwartz reference teaches the fixation system of claim 2, further comprising a proximal base (Figure 5; locking ring 70 may be interpreted as a proximal base given it is a base positioned at the proximal end of the clamp) having a pocket configured to accommodate the protuberances (Figure 5; 72), the pocket having an opening to allow the one or more saddles and the branches to extend through the opening of the pocket in a distal direction (Figure 5; middle section 25 may be interpreted as being a portion of a saddle 23, which may extend through opening 72).
Concerning claim 4, the Schwartz reference teaches the fixation system of claim 3, wherein the proximal base comprises a sloped mating ramp on an interior of the pocket, the sloped mating ramp configured to engage with the force receiving areas and apply contact force to the force receiving areas, thereby urging the first branch and the second branch towards each other, when a force is applied to the one or more saddles in a distal direction (Figure 6; 72).
Concerning claim 6, the Schwartz reference teaches the fixation system of claim 2, wherein the force receiving areas are a distalmost portion of a distal surface of the protuberances (Figure 5; 29).
Concerning claim 10, the Schwartz reference teaches the fixation system of claim 3, wherein at least one of the branches has a barb extending out from the at least one branch (Figure 5; point of tip 29 may be interpreted as a barb), the barb adapted to engage with a mating lip of the proximal base (Figure 5; lip defined by recess 72) to prevent the clamp from moving in a proximal direction relative to the proximal base after the barb is engaged with the mating lip.
Concerning claim 11, the Schwartz et al. prior art reference teaches a fixation system for knotlessly stabilizing anatomical structures (Figures 1-8), the system comprising: a flexible member (Figure 5; 40); and a proximal button assembly (Figure 5; 20), the proximal button assembly comprising: one or more saddles (Figure 5; 23), the one or more saddles capable of having the flexible member wrapped around the one or more saddles to form two or more loops around the one or more saddles and an anatomical structure of the patient (this is a functional/intended use limitation, wherein the flexible member may be looped in any manner desired by the user); a first protuberance (Figure 5; 26) having a first jaw (Figure 5; surface of 26 including teeth 32), and a second protuberance (Figure 5; 28) having a second jaw (Figure 5; surface of 28 including teeth 32), the first and second jaw defining a clamping area (Figure 5; 30), wherein the flexible member is adapted to be passed through an anatomical structure of a patient to form a loop through the anatomical structure (this is a functional/intended use limitation, wherein the flexible member may be looped in any manner desired by the user), and wherein the flexible member is adapted to be passed through the clamping area of the proximal button assembly, the clamping area adapted to clamp onto the flexible member and lock the flexible member in the clamping area (Figure 6); the one or more saddles operatively connected to the first protuberance and the second protuberance, whereby a force applied in a distal direction of the one or saddles by the flexible member may cause the first protuberance and the second protuberance to be urged together, thereby closing the clamping area around the flexible member (this is a functional/intended use limitation, wherein the flexible member may be looped in any manner desired by a user, wherein depending on the specific looping and threading path chosen by the user, a force is capable of being applied in a distal direction by the flexible member to convert the proximal button assembly from the configuration of Fig. 5 to Fig. 6).
Concerning claim 12, the Schwartz reference teaches the fixation system of claim 11, further comprising a proximal base (Figure 5; 70) having a pocket (Figure 5; 72) configured to accommodate the protuberances (Figure 5; 26, 28), the pocket having an opening to allow the one or more saddles and the flexible member to extend through the opening in the distal direction (Figure 5; middle portion 25 may be interpreted as being part of the saddle, which may extend through opening 72).
Concerning claim 13, the Schwartz reference teaches the fixation system of claim 13, wherein the proximal base further comprises a sloped mating ramp on an interior of the pocket (Figure 5; sloped interior surface of 72), the sloped mating ramp configured to engage with the protuberances and urge the protuberances towards each other when a force is applied to the one or more saddles in a distal direction (Figure 6).
Concerning claim 14, the Schwartz reference teaches the fixation system of claim 11, further comprising a distal button (Figure 1; 80) having a pair of openings (Figure 1; 82, 84) adapted for the flexible member to be routed through the distal button as part of the two loops around the anatomical structure (Figure 1; 40).
Claim(s) 1, 2, and 7-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Golds et al. (US 5,383,905, hereinafter Golds).
Concerning claim 1, the Golds et al. prior art reference teaches a fixation system for knotlessly stabilizing anatomical structures (Figure 1; 10), the system comprising: a clamp (Figure 1; 16) comprising: a first branch and a second branch (Figure 1; 20), the first branch and the second branch adapted to move towards each other to close the clamp (Figure 9); one or more openings at a distal end of at least one of the first or second branch (Figure 1; 22), the openings adapted for a flexible member to be passed through them (Figure 4; 42), wherein said flexible member is capable of forming two or more loops around one or more saddles (Figure 1; 18) and a distal button (distal button, and flexible member is merely functionally recited, thus it must simply be capable of forming two loops around one or more saddle structures or a distal button); a first protuberance at a proximal end of the first branch; a second protuberance at a proximal end of the second branch (Figure 1; teeth 32 = protuberances); and a first jaw on the first protuberance and a second jaw of the second protuberance (Figure 5; surface of branches 20 defining teeth 32 = jaws), the first and second jaws defining a clamping area, the first and jaws adapted for clamping and knotlessly securing the flexible member within the clamping area between the jaws (Figure 9).
Concerning claim 2, the Schwartz reference teaches the fixation system of claim 1, wherein the clamp further comprises a force receiving area on each of the protuberances (Figure 10; outer surface of teeth 32 = force receiving area), the force receiving areas laterally distant from a distal-proximal central axis of the clamp, the force receiving areas adapted to receive contact force, thereby urging the first branch and the second branch towards each other (Figure 10).
Concerning claim 7, the Schwartz reference teaches the fixation system of claim 2, wherein the one or more saddles is a single saddle (Figure 1; ring structure 18 may be interpreted as a single saddle), and the first branch and the second branch extend proximally from the saddle (Figure 1; 20), the first branch and second branch flexing slightly towards each other at their proximal ends to bring the jaws together when a force is applied to the saddle in a distal direction (flexible member is capable of being threaded and looped in such a way as to apply a distal force to the saddle to pull the clamp through a proximal base).
Concerning claim 8, the Schwartz reference teaches the fixation system of claim 2, wherein the one or more saddles may be interpreted as a first saddle and a second saddle (Figure 2; portions of ring 18 between branches defined by 26 may be interpreted as separate saddles), the first saddle on a proximal portion of the first branch and the second saddle on a proximal portion of the second branch, the first saddle and the second saddle configured to be arranged laterally distant from each other so that the flexible member can be looped through each saddle separately (this is a functional/intended use limitation, wherein the flexible member may be looped in any manner desired by the user), wherein the first protuberance and the second protuberance are urged towards each other when a force is applied to the first and second saddle in a distal direction (flexible member is capable of being threaded and looped in such a way as to apply a distal force to the first and second saddles to pull the clamp through a proximal base).
Concerning claim 9, the Schwartz reference teaches the fixation system of claim 2, wherein the one or more saddles may be interpreted as a first saddle and a second saddle (Figure 2; portions of ring 18 between branches defined by 26 may be interpreted as separate saddles), the first and second saddle configured to be stacked together so that the flexible member can be looped through both saddles together (this is a functional/intended use limitation, wherein the flexible member may be looped in any manner desired by the user), wherein the first protuberance and the second protuberance are urged towards each other when a force is applied to the first and second saddle in a distal direction (flexible member is capable of being threaded and looped in such a way as to apply a distal force to the first and second saddles to pull the clamp through a proximal base).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The Gray reference (US 4,455,717) teaches a fixation system including a clamp with a saddle connected to a first branch and second branch which may be urged towards each other by a proximal base to clamp a flexible member; the Myers reference teaches a suture fixation system including a proximal button and a distal button, wherein the proximal button may include a clamp with a saddle connected with a first branch and a second branch; the Perriello et al. reference (US 2013/0035720) teaches a fixation system for knotlessly securing a flexible member including a proximal button assembly comprising a clamp and a proximal base, a distal button, and a flexible member; and the Chavan et al. reference (US 2018/0249998) and the Niver et al. reference (US 2021/0068806) both teach a fixation system for knotlessly securing a flexible member including a proximal button assembly comprising a saddle connecting first a second branches and a base, a distal button, and a flexible member.
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 6/18/2026
Prosecution Insights