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 .
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 (e.g., ‘eyelet body’) connotes sufficient structure to a POSITA. See MPEP § 2181. If applicant contends otherwise, please point to supporting disclosure.
Claim Objections
Claim 9 is objected to because of the following informalities: please change “the sutures” to “the at least one suture”. Appropriate correction is required.
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.
Claim(s) 1-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wilford (US 2002/0156476A1) in view of Dreyfuss et al. (US 2010/0160962A1, “Dreyfuss”).
Regarding claims 1 and 11, Wilford discloses an implant system including a first component (14; [0055]) includes an eyelet body defining an eyelet opening (32; Fig. 1) capable of receiving a mesh implant with at least one suture attached thereto. A connector projection extends from the eyelet body and includes first and second legs (46, 48; Fig. 3, 5; [0056]) that extend from the eyelet body. The first and second legs define a gap (43; Fig. 3) therebetween. A second component includes a second component body (12; Figs. 2, 4). The second component body defines a bore (18; Fig. 2) extending through a first end of the second component body. The first end is capable of receiving each of the first and second legs to rotatably couple the first and second components ([0056];Fig. 5). The first and second components forming an interference implant. Each of the eyelet body and the second component body define an outer diameter of the interference implant that is continuous along a length of the second component at least a portion of the eyelet body (Fig. 4). However, Wilford does not disclose a mesh implant including at least one suture attached to the mesh implant.
In the same field of endeavor, fixation devices, Dreyfuss teaches an implant system including a fixation device (62) having a mesh implant (2; Fig. 2; formed of mesh, braided polyester construct). The mesh implant includes at last one suture (11; [0035]) attached thereto. The mesh implant is capable of being disposed through an eyelet (64; [0023]) of the fixation device. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided the fixation device of Wilford with a mesh implant and at least one suture, as taught by Dreyfuss, to provide means for soft tissue to bone repairs [0024].
Regarding claims 2, 12 and 20, the combination of Wilford and Dreyfuss discloses that upon insertion of the first component and second component into bone, the mesh implant and/or the at least one suture are capable of being positioned through the eyelet opening (Fig. 4; Wilford, Fig. 4, 9; Dreyfuss). The mesh implant is capable of being positioned along a length of the second component along a first sidewall portion of the second component. At least one of the mesh implant and/or the at least one suture are capable of being positioned along the length of the second component along a second sidewall portion of the second component. The first sidewall portion is circumferentially distanced from the second sidewall portion.
Regarding claim 3, the combination of Wilford and Dreyfuss discloses that a second end of the second component body defines a driver coupling opening (24; Wilford; [0054]) capable of receiving a driver for applying torsional and/or linear forces to the second component.
Regarding claim 5, the combination of Wilford and Dreyfuss discloses a first end of the eyelet body having a first width and a second end of the eyelet having a second width that is greater than the first width.
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Regarding claim 6, the combination of Wilford and Dreyfuss discloses that the connector projection of the first component includes a third leg extending from the eyelet body. Each of the first, second and third legs (136) define the gap therebetween (Fig. 8).
Regarding claim 7, the combination of Wilford and Dreyfuss discloses that a portion of the connector projection extending from the eyelet body is curvilinear (Fig. 3, 5, a flared tip forms a curved surface). The first end of the second component body defines a bore wall capable of engaging with the connector projection capable of facilitating rotation of the first component relative to the second component.
Regarding claim 8, the combination of Wilford and Dreyfuss discloses that the bore wall of the second component defines a tapered surface and at least a portion of the connector projection extends from the eyelet body has a tapered surface. The tapered surfaces are capable of facilitating engagement between the first and second components (Figs. 3, 5).
Regarding claim 9, the combination of Wilford and Dreyfuss discloses that the eyelet opening is further capable of receiving and coupling to each of the mesh implant and/or the at least one suture (Fig. 1; Wilford, Fig. 2; Dreyfuss).
Regarding claim 10, the combination of the Wilford and Dreyfuss discloses that upon insertion of the first and second components into a bone, the mesh implant and/or the at least one suture are capable of being positioned through the eyelet opening and along a length of the second component (Fig. 1; Wilford, Fig. 2, 9; Dreyfuss).
Regarding claim 13, the combination of the Wilford and Dreyfuss discloses that the second component body includes a thread along at least a portion of the length of the second component body (Fig. 1; Wilford).
Regarding claim 14, the combination of the Wilford and Dreyfuss discloses that the thread includes at least one helical thread having a helical pitch length (Fig. 1; Wilford). A length of the thread along the length of the second component body is at least two times the helical pitch length (Fig. 1).
Regarding claim 15, the combination of the Wilford and Dreyfuss discloses that the second component body includes an unthreaded section (Fig. 4, near the reference number 16) that extends from the first end and adjacent to the first component.
Claim(s) 4 and 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wilford in view of Dreyfuss, as applied to claim 3 above, and further in view of Dougherty et al. (US 2016/0030032A1, “Dougherty”).
Regarding claim 4, the combination of Wilford and Dreyfuss does not disclose that the bore of the second component body extends between the first and second ends.
In the same field of endeavor, fixation devices, Dougherty teaches a device (400) having a driver coupling opening [0073; Fig. 3D]. The device includes a bore that extends between first and second ends (Fig. 3D). 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 formed the bore of the second component combination of the Wilford and Dreyfuss to extend between the first and second ends, as taught by Dougherty, as another means for accommodating various lengths of connector projections.
Regarding claim 16, the combination of Wilford and Dreyfuss does not disclose that the bore of the second component defines a first bore section and a second bore section that are continuous therebetween. In the same field of endeavor, fixation devices, Dougherty teaches a first bore section (440; Fig. 3D; Dougherty) extending from the first end (444) of the second component body and is continuous with the second bore section (436). 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 driver coupling opening of the combination of Wilford and Dreyfuss with the driver coupling opening, as taught by Dougherty, as this modification involves the simple substitution of one driver coupling opening with another for the predictable result of providing means for coupling a driver to the anchor.
Regarding claim 17, the combination of Wilford, Dreyfuss and Dougherty discloses that the second bore section includes a plurality of splines (432; Fig. 3B, D; Dougherty) along an inner surface of at least a portion of the second bore section. The plurality of splines are capable of engaging a driver member within the second bore section [0073].
Regarding claim 18, the combination of Wilford, Dreyfuss and Dougherty discloses that the first component includes pawls extending from the connector projection (flared tips, 50; Fig. 3, 5).
Allowable Subject Matter
Claim 19 is 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Le Couedic et al. (US 2010/0331896A1) discloses first and second components, and eyelet body and a connector projection.
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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