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 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 68, 70-77, 79, 83, and 85 are rejected under 35 U.S.C. 103 as being unpatentable over Wahab et al. FR 3013211A1 (hereafter referred to as Wahab; refer to the attached translation for passages referenced herein) in view of Taylor et al. US 2015/0272741 (hereafter referred to as Taylor; cited in IDS) and in further view of Münder DE10128234A1 (hereafter referred to as Münder; refer to the attached translation for passages referenced herein).
Regarding claim 68, Wahab discloses a method of installing a glenoid implant in a glenoid of a patient (figs. 1-3), the method comprising: providing a glenoid implant 1 including: (i) a body 2 having a first side with a concave surface 5 and a second opposing side with a convex surface 6, the convex surface having a peripheral area surrounding a central area (figs. 1 and 3); (ii) a central peg 3 extending from the central area of the convex surface (fig.1); and (iii) a plurality of peripheral pegs 4 extending from the peripheral area of the convex surface (figs. 1 and 5), each of the peripheral pegs having at least one radially extending feature (the rings extending outwardly from the grooves as shown in figs. 1-3 and 5); applying bone cement to (i) at least a portion of the central peg (see the translation page 3, par.1, last sentence), (ii) at least a portion of the central bore, or (iii) both (i) and (ii); positioning, the glenoid implant such that: (i) at least a portion of the convex surface directly engages the mating surface of the prepared glenoid, (ii) the central peg is positioned within a central bore of the glenoid, and (iii) each of the plurality of peripheral pegs is positioned within a respective one of a plurality of peripheral bores of the prepared glenoid (figs.2-3). Wahab discloses the invention substantially as claimed but does not disclose that the glenoid is a prepared glenoid having a mating surface, a central bore, and a plurality of peripheral bores, the step of positioning the glenoid implant via at least one or more tools, or maintaining while the bone cement cures, the position of the glenoid implant relative to the prepared glenoid via the at least one radially extending feature of the plurality of peripheral pegs.
Taylor teaches a method of installing a glenoid implant, in the same field of endeavor, wherein the method comprises installing the glenoid implant in a prepared glenoid of the patient, the prepared glenoid having a mating surface, a central bore, and a plurality of peripheral bores for the purpose of receiving the pegs of the implant (par.36). Taylor further teaches peripheral pegs comprise radially extending features 40, wherein the radially extending features are press-fit into the scapula for the purpose of providing initial stability and a secure fit between the implant and the scapula, wherein cement is also used within the bores (par.37). Finally, Taylor teaches applying a force to the implant so that the fins of the pegs engage the bores of the scapula in a press-fit configuration (par.37).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Wahab to include installing the glenoid implant in a prepared glenoid having a mating surface, a central bore, and a plurality of peripheral bores as taught by Taylor in order to allow for the glenoid implant to be easily implanted in the scapula. Bone preparation is standard in joint replacement procedures. It would have been further obvious to modify the radially extending features of the peripheral pegs of Wahab to include the fins taught by Taylor, wherein the fins maintain, while bone cement cures, the position of the implant relative to the prepared glenoid in order to provide initial stability and a secure fit between the glenoid implant and the scapula. Finally, it would have been obvious to modify the method of Wahab and use a tool to apply a force to the implant as taught by Taylor in order to engage the pegs with the bores in the scapula as is customary in the art. Because Taylor teaches that the fins of the peripheral pegs provide initial stability to the implant which is used in combination with bone cement (par.37), it seems that the insertion tool would not be required to hold the glenoid implant in position while the bone cement cures. Still, Wahab and Taylor do not specifically disclose the step of disengaging the one or more tools from the glenoid implant prior to the bone cement curing.
Münder teaches a method of installing a concave implant, in the same field of endeavor, wherein an insertion tool is disengaged from the implant prior to the bone cement curing for the purpose of preventing movement of the implant by the tool since such movement can adversely affect the fixation (translation page 2 last three lines to page 3 line 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Wahab in view of Taylor and disengage the insertion tool from the glenoid implant immediately and prior to the bone cement curing as taught by Münder in order to avoid inadvertent movement of the implant caused by the tool. Further, since Taylor teaches the fins/radially engaging feature provide initial stability and a secure fit, holding the implant in place would not be required and it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention remove the tool from the implant and the patient as soon as possible to shorten the time of surgery.
Regarding claims 70 and 71, see Taylor par.37 for cement being inserted into the holes in the scapula. Since the cement is applied in the holes, the cement is not applied to the peripheral pegs prior to the positioning.
Regarding claim 72, the length of the pegs of both Wahab and Taylor are such that the radially extending features are capable of engaging cancellous bone when the implant is fully seated.
Regarding claim 73, see Taylor par.31 for the fins being allowed to flex when the implant is assembled into the bone.
Regarding claim 74, see Taylor par.37 for the fins being capable of flexing to insure initial stability and a secure fit.
Regarding claims 75-77, see Wahab fig.1 for the longer length of central peg 3 compared to shorter peripheral pegs 4.
Regarding claims 79 and 83, see Wahab fig.1 for different diameters of the central peg and peripheral pegs including the radially extending features.
Regarding claim 85, see Taylor figs. 3A-3D for the radially extending features 40 being disks with lobes.
Claim 69 is rejected under 35 U.S.C. 103 as being unpatentable over Wahab in view of Taylor and Münder as applied to claim 68 above, and further in view of Guerderian et al. US 2009/0125113 (hereafter referred to as Guerderian; cited in IDS). Wahab in view of Taylor and Münder discloses the method of claim 68 as discussed above but does not disclose prior to positioning, applying bone cement to at least a portion of the convex surface.
Guerderian teaches a method of installing a glenoid implant, in the same field of endeavor, wherein cement is applied to cavities as well as surfaces of the glenoid implant which may come in contact with bone (par.28) for the purpose of improving the pull out characteristics of the glenoid implant (par.20).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply cement to the bone contacting convex surface of Wahab since Guerderian teaches applying cement to all surfaces that contact bone in order to improve the pull out characteristics of the glenoid implant.
Claim 78 is rejected under 35 U.S.C. 103 as being unpatentable over Wahab in view of Taylor and Münder as applied to claim 75 above, and further in view of Reubelt et al. US 2007/0225817 (hereafter referred to as Reubelt). Wahab in view of Taylor and Münder discloses the method of claim 75 as discussed above but does not disclose that the first height is between about two millimeters and about twenty millimeters.
Reubelt teaches a glenoid implant, in the same field of endeavor, wherein a peg has a height of about 3-20 mm to minimize the potential of scapula perforation (par.76).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the central peg of Wahab to have a length of about 3-20 mm as taught by Reubelt since Reubelt teaches this is a suitable height for glenoid implant pegs to minimizes the potential of scapular perforation.
Claim 82 is rejected under 35 U.S.C. 103 as being unpatentable over Wahab in view of Taylor and Münder as applied to claim 79 above, and further in view of Rockwood, Jr. et al. US 6,911,047 (hereafter referred to as Rockwood; cited in IDS). Wahab in view of Taylor and Münder discloses the method of claim 79 as discussed above but does not disclose that the first diameter is between about one millimeter and about 15 millimeters.
Rockwood teaches a glenoid implant, in the same field of endeavor, wherein a central peg with fins comprises a shaft diameter of about 4.72 mm and a fin diameter of about 8.87 mm for the purpose of providing a large amount of anchoring force (col.6, lines 18-21).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the central peg of Wahab to have a diameter of about 4.72 mm (at the shaft) or about 8.87 mm (at the radially extending feature) as taught by Rockwood in order to provide a large amount of anchoring force.
Claims 86 and 87 are rejected under 35 U.S.C. 103 as being unpatentable over Wahab in view of Taylor and Münder as applied to claims 68 and 85 above, and further in view of de Beaubien et al. 2016/0367371 (hereafter referred to as de Beaubien; cited in IDS). Wahab in view of Taylor and Münder discloses the method of claims 68 and 85 as discussed above. Both Wahab and Taylor disclose each of the plurality of peripheral pegs includes at least a first radially extending feature and a second radially extending feature. Taylor further teaches in par.33 “While the peripheral surface 44 is shown with equally sized and space dimples 46, it will also be appreciated that the peripheral surface 44 may include different sized and spaced dimples 46 within the scope of the present disclosure. In this regard, a first of the annular fins 40 may include a first plurality of dimples 46 having a first size and shape, and another of the annular fins 40 may include a second plurality of dimples 46 having a second size and shape different than the first size and shape”. Taylor teaches in par.34 “the size, shape and location of the dimples 46 can be varied to adjust the flow characteristics of the bone cement and/or to adjust the flexural characteristics of the annular fin 40”. In other words, Taylor teaches that the lobes/fins and dimples between the lobes in each row may have different sizes and shapes and can be varied to adjust the flow of the bone cement. However, Wahab in view of Taylor and Münder does not specifically disclose that lobes of the first radially extending feature are angularly offset with respect to lobes of the second radially extending feature, or wherein the at least one radially extending feature includes helical channels.
De Beaubien teaches a shoulder implant (par.64), in the same field of endeavor, wherein a peg of the implant comprises a plurality of rows of radially extending features comprising disks with lobes wherein lobes of a first radially extending feature are angularly offset with respect to lobes of a second radially extending feature (fig.3B) for the purpose of allowing an agent to flow more freely within the bone (par.136). The offset lobes form helical channels (fig.3B; par.136).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to angularly offset the lobes of the first and second radially extending features of Wahab in view of Taylor and Münder thereby forming helical channels as taught by de Beaubien in order to alter and improve the flow of cement around the peg to better secure the implant to the bone.
Allowable Subject Matter
Claims 80, 81, and 84 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.
The following is a statement of reasons for the indication of allowable subject matter: All of the prior art references disclose a central peg having a greater diameter than the diameter of each peripheral peg. Wahab specifically discloses that the peripheral pegs each have a diameter of about two less than that of the central peg (see the translation of Wahab page 3, first paragraph). Therefore, the prior art does not disclose, teach, or suggest the method of claims 80, 81, and 84.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Winslow et al. US 2011/0035013 discloses bonding a convex surface to bone with cement (par.43) as well as filling holes with cement (fig.13).
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/MEGAN Y WOLF/Primary Examiner, Art Unit 3774
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