DETAILED ACTION
This Office Action is in response to the Amendment filed 9 July 2026. Claim(s) 1-18 are currently pending. The Examiner acknowledges the amendments to claim(s) 113 and 14.
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 .
Claim Interpretation
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.
No claim limitation has been interpreted under 35 U.S.C. 112(f) because each term connotes sufficient structure to a POSITA. See MPEP § 2181. If applicant contends otherwise, please point to supporting disclosure.
Claim Rejections - 35 USC § 102
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 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) 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bourque et al. (US 2007/0219557A1, “Bourque”).
Regarding claim 13, Bourque discloses a system for securing an implant to bone including an instrument having a shaft (625; Fig. 37) and a bone implant (700) mounted on the shaft. The bone implant includes threading (Fig. 38A) spiraling around the bone implant in a first direction. The bone implant includes a distal component and a proximal fixation component. The distal component receiving a suture (708 of 710; Fig. 38C; [0089]). The suture (710) is wrapped around the shaft such that it spirals around the shaft in a second direction opposite the first direction, wherein the wrapped portion (716) is wrapped around the inner shaft in a direction opposite to the rotational direction imparted to the anchor during delivery [0087]. For example, if the threads were applied for clockwise rotation during delivery/insertion, the suture would be wrapped in a direction opposite (counter-clockwise) to the threads.
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 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.
Claim(s) 1-3 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Balboa et al. (US 2019/0167254A1, “Balboa”) in view of Patel et al. (US 2021/0338224A1; “Patel”) in view of Brunelle et al. (US 2010/0063541A1, “Brunelle”).
Regarding claims 1-3, Balboa discloses an elastomeric device including an instrument having an outer cannulated shaft (118/218; Fig. 1; [0028]), an inner shaft (120/220) received in the outer cannulated shaft in a sliding fashion. A bone implant including a distal component (228; [0044];Fig. 11) and a proximal fixation component (226). The distal component is mounted on the inner shaft [0044; Fig. 11). The distal component includes an eyelet (opening through which 224 extends; claim 3) and is mounted on the distal end of the inner shaft and is capable of receiving the elastomeric device such that the elastomeric device extends through an opening of the eyelet. The proximal component includes one or more bone engaging features (threading; Fig. 11) extending from an outer surface of the proximal component. Balboa discloses that a suture (224; Fig. 11C; suture is wrapped along the sides of the distal component in the proximal direction, 342; Fig. 12C; suture is coiled around distal component 328; [0049]). However, Balboa does not disclose that the suture is an elongated, elastomeric, porous matrix material or a lock movable between a locked configuration and an unlocked configuration, wherein the locked configuration prevents the inner shaft from sliding relative to the outer shaft, wherein the unlocked configuration permits the inner shaft to slide relative to the outer shaft; wherein, when the lock is in the locked configuration, the distal component mounted on the inner shaft is spaced apart from the proximal component; wherein, when the lock is in the unlocked configuration, the inner shaft is permitted to slide relative to the outer shaft to move the proximal component towards the distal component.
In the same field of endeavor, bone anchor insertion, Patel teaches an inserter including inner and outer shafts (1210, 1208; [0263]; Fig. 54-56) and a locking mechanism (1238). A locked configuration prevents the inner shaft from sliding relative to the outer shaft, wherein the unlocked configuration permits the inner shaft to slide relative to the outer shaft [0263]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the device of Balboa with the locking mechanism, as taught by Patel, to prevent premature distal translation of the outer shaft relative to the inner shaft during a procedure. With this modification, when the lock is in the locked configuration, the distal component mounted on the inner shaft is spaced apart from the proximal component and when the lock is in the unlocked configuration, the inner shaft is permitted to slide relative to the outer shaft to move the proximal component towards the distal component.
In the same field of endeavor, bone implants, Brunelle teaches a bone implant including a suture (28; [0060]; Fig. 9, 10) connected to a tissue scaffold (25). Balboa discloses a suture that extends through an eyelet in the distal component of the bone implant (Fig. 11; [0042]; 224). The scaffold may be formed of polyurethane [0062] which is known to be an elastomeric material, e.g. highly stretchy and elastic. The scaffold is porous to provide cellular propagation [0061] and is in the form of a matrix/mesh [0061]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the suture of Balboa with suture and scaffold assembly, as taught by Brunelle, to encourage cellular growth and development between the tissue and the surrounding bone [0089].
Regarding claim 11, the combination of Balboa, Patel and Brunelle discloses a suture wrapped around the outer cannulated shaft (Fig. 11C; [0042]; Balboa).
Allowable Subject Matter
Claims 4-10, 12 and 14-18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 13 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Dougherty et al. (US 2019/0053888A1) discloses a suture wrapped around a distal component of a bone implant (Fig. 44).
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 JOCELIN C TANNER whose telephone number is (571)270-5202. The examiner can normally be reached M-F 8am-4pm.
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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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/JOCELIN C TANNER/Primary Examiner, Art Unit 3771
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