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 .
This action is in response to amendment filed on 07/03/2026. Claims 1-15 and 21-25 are pending. Claims 1, 24, and 25 are independent. Claims 9-12 and 16-20 are withdrawn. Claims 16-20 are canceled.
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.
Currently, none of the limitations are interpreted under 35 U.S.C. 112(f).
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.
Claim 23 is 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 23 recites the limitation ‘the suture passage through which the suture is loaded prior to passing through the cannulation.” As disclosed in the specification, the suture is different part than the locking ferrule. The limitation, ‘the suture passage through which the suture is loaded prior to passing through the cannulation,” positively recites the suture to be part of the locking ferule and is therefore considered as new matter. For the purpose of examination, the limitation is interpreted to be “the suture passage through which the suture can be loaded prior to passing through the cannulation.”
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 25 is 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 25 recite the limitation “the suture is looped around the band and then through the cannulation.” The limitation is indefinite because it is unclear whether the claim is describing a physical structure or a chronological sequence of events. If the limitation is referring to a chronological sequence of events, then the limitation is a method which is in a different statutory class than the apparatus.
The art rejection(s) below is/are made as best understood by the examiner because of the 35 U.S.C. 112(b) issue stated above.
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 1, 2, 5-8, and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Liu (US Pub. No.: 2019/0076141) in view of Bless (US Pub. No.: 2010/0249855) as evidenced by House et al. (US Pub. No.: 2023/0310031).
Regarding claim 1, Liu discloses a locking ferrule (200, Figs. 2C and 4A) for performing tissue repairs, comprising: a body (205, Fig. 4A) extending between a first end (the end at the bottom of Fig. 4A) and a second end (the end at the top of Fig. 4A) and including an outer diameter wall (outer diameter wall, Figs. 2C and 4A), an inner diameter wall (inner diameter wall, Figs. 2C and 4A), and a cannulation (passageway of 205, Fig. 4A) that is circumscribed by the inner diameter wall; and a plurality of locking barbs (210, Figs. 2C and 4C) extending into the cannulation and configured to lock a suture that is received through the cannulation relative to the body (Para. [0031]). However, Liu does not disclose an eyelet connected to the body near the first end or the second end.
Bless teaches, in the same field of endeavor (suture / bone anchor), a locking ferrule (1, Figs. 6 and 7) comprising an eyelet (combination of rods 11 and ring 13, Fig. 6) connected to the body near the second end of the body of the locking ferrule (Figs. 6 and 2).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the locking ferrule of Liu to include an eyelet connected to the body near the second end of the body of the locking ferrule as taught by Bless in order to obtain the advantage of providing a bearing for knotting of the suture to the locking ferrule (Bless, Paras. [0016] and [0044]-[0045]). As evidenced by House, the end(s) of the suture is/are still loose after using the locking ferrule. House specifically provides the evidence that a tie member (28, Fig. 2) would help securing the ends of a suture even though the suture is adjustable locked by the locking barbs. This allows the end of the suture to be tied-off rather than allowing the end to be looser requiring the clinician to cut the loose end (House, Para. [0012]).
Regarding claim 2, Bless discloses that the eyelet is integrally formed with the body (Bless, Fig. 2).
Regarding claim 5, Liu in view of Bless discloses that the eyelet is connected to the second end (In the modified invention, the eyelet is connected to the second end because eyelet of Bless is located at the second end at which the suture is pulled, Bless, Fig. 6 and Liu, Fig. 4A).
Regarding claim 6, Bless discloses that the eyelet includes a band (Bless, Fig. 6, combination of rods 11 and ring 13 forms the band) that connects to the second end and a suture passage that extends between the band and the second end.
Regarding claim 7, Bless discloses that the suture is looped around the band (Bless, Fig. 7).
Regarding claim 8, Liu in view of Bless discloses that the plurality of locking barbs are angled in a direction toward the eyelet (Liu, Fig. 4A and Bless, Fig. 6, the plurality of locking barbs are angled in a direction toward the eyelet because the eyelet is located at the second end at which the sutures are pulled)
Regarding claim 13, Liu discloses that the plurality of locking barbs each protrude inwardly from the inner diameter wall (Liu, Fig. 4A).
Regarding claim 14, Liu discloses that the plurality of locking barbs are arranged in at least a first row and a second row (Liu, Fig. 2C).
Regarding claim 15, Liu discloses that a first portion of the plurality of locking barbs of the first row are staggered relative to a second portion of the plurality of locking barbs of the second row (Liu, Fig. 2C).
Claim(s) 3 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu (US Pub. No.: 2019/0076141) in view of Bless (US Pub. No.: 2010/0249855) as evidenced by House et al. (US Pub. No.: 2023/0310031) as applied to claim 1 above, and further in view of Stone et al. (US Pat. No.: 5,824,011).
Regarding claim 3, Liu in view of Bless discloses all the limitations of claim 1 as taught above. Liu in view of Bless further discloses that the body is comprised of a first material but fails to disclose the eyelet is comprised of a second material that is different from the first material.
Stone teaches, in the same field of endeavor (suture/bone anchor), an eyelet (16, Figs. 1 and 2; alternatively, 28, Fig. 6) of a locking anchor (12, Figs. 1 and 2 or Fig. 6) comprising a second material that can be either same or different from a first material of the body of the locking anchor (Abstract, Col. 4, line 63 – Col. 5, line 13, Col. 7, lines 18-21).
Before the effective filing of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the locking ferrule of Liu in view of Bless to include that the eyelet is comprised of a second material that is different from the first material as taught by Stone to allow the different portions of the locking ferrule to be manufactured independently withing conventional methods as an alternative to integrally form the locking ferrule (Stone, Col. 4, line 63- Col. 5, line 7).
Regarding claim 4, Stone discloses that the second material includes suture (Stone, Col. 7, lines 18-21, suture structure 28.).
Claim(s) 21-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu (US Pub. No.: 2019/0076141) in view of Bless (US Pub. No.: 2010/0249855) as evidenced by House et al. (US Pub. No.: 2023/0310031) as applied to claims 1 and 6 above, and further in view of House et al. (US Pub. No.: 2023/0310031).
Regarding claims 21-23, Liu in view of Bless discloses all the limitations as taught above. Bless further discloses that the eyelet includes a band that connects to the first end or the second end at two spaced-apart connection points (combination of rods 11 and ring 13 forms the band, Fig. 6 and see Figure below) to define a suture passage between the band and the first end or the second end (see Figure below); wherein the band and the suture passage are both located entirely outside of the cannulation (see Figure below). However, neither Liu nor Bless discloses that the eyelet arches outwardly away from the second end.
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House teaches, in the same field of endeavor (suture anchor), an eyelet (28, Fig. 2) arches outwardly away from the body of a locking ferrule (20, Fig. 2) to define a suture passage.
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the eyelet of the invention of Liu view of Bless to arch outwardly away from the body as taught by House, such as the end of the body/cannulation, in order to facilitate the suture to loop through the eyelet. In the modified device, a suture is fully capable to be loaded prior to passing through cannulation.
Claim(s) 24 are is/are rejected under 35 U.S.C. 103 as being unpatentable over House et al. (US Pub. No.: 2023/0310031) in view of Bless (US Pub. No.: 2010/0249855).
Regarding claim 24, House discloses a locking ferrule (20, Fig. 2) for performing tissue repairs, comprising: a body (body of 20, Fig. 2) extending between a first end (end of the left side of Fig. 2) and a second end (end on the right side of Fig. 2) and including an outer diameter wall (Fig. 2), an inner diameter wall (Fig. 2), and a cannulation (23, Fig. 2) that is surrounded by the inner diameter wall; an eyelet connected to the body (28, Fig. 2), the eyelet including a band (band 28, Fig. 2) that connects to body at two spaced-apart connection points and arches outwardly away from body (Fig. 2) to define a suture passage (Para. [0054]), the suture passage being capable to receive a suture looped around the band (suture makes a knot with a suture looped around the band, Para. [0054]); and a plurality of locking barbs (24, Fig. 2) extending into the cannulation and configured to lock the suture that is received through the cannulation relative to the body. However, House does not disclose that the eyelet including the band is connected near the second end such that it forms a suture passage between the band and the second end.
Bless teaches, in the same field of endeavor (suture anchor), an eyelet (combination of rods 11 and ring 13, Fig. 6) including a band (combination of rods 11 and ring 13, Fig. 6) connected to second end of the body (see Figure below) such that it forms a suture passage between the band and the second end.
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Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the location of the eyelet to be at the second end a taught by Bless require a smaller amount of suture and/or facilitating the surgical procedure since it does not require the suture to loop to the side of the body of the locking ferrule.
Response to Arguments
Applicant's arguments with respect to claims 1-8 and 13-15 filed 07/03/2026 have been fully considered but they are not persuasive. Liu describes using the knotting tube to omit the need for a knot to be tied to lock the suture against the surgical site (Para. [0029]). However, Liu does not exclude the loose ends of the suture to be knotted and does not address the problem of the loose ends of the suture after locking the suture with the knotting tube. Bless teaches, in the same field of endeavor (suture / bone anchor), a locking ferrule (1, Figs. 6 and 7) comprising an eyelet (combination of rods 11 and ring 13, Fig. 6) connected to the body the second end of the body of the locking ferrule (Figs. 6 and 2). Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the locking ferrule of Liu to include an eyelet connected to the body near the second end of the body of the locking ferrule as taught by Bless in order to obtain the advantage of providing a bearing for knotting of the suture to the locking ferrule (Bless, Paras. [0016] and [0044]-[0045]). As evidenced by House, the end(s) of the suture is/are still loose after using the locking ferrule. House specifically provides the evidence that a tie member (28, Fig. 2) would help securing the ends of a suture even though the suture is adjustable locked by the locking barbs. This allows the end of the suture to be tied-off rather than allowing the end to be looser requiring the clinician to cut the loose end (House, Para. [0012]).
Applicant’s arguments with respect to claim(s) 21-25 have been considered but are moot in in view of new ground(s) of rejection.
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 JING RUI OU whose telephone number is (571)270-5036. The examiner can normally be reached M-F 9:00am -5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JING RUI OU/Primary Examiner, Art Unit 3771
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