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 .
Response to Arguments
Applicant's arguments filed 8/6/2026 have been fully considered but they are not persuasive. Claim 68 was amended to recite “each of the peripheral pegs having a central axis and at least [[one]] two radially extending feature features, wherein each of the at least two radially extending features lie in a plane that is generally orthogonal to the central axis, and wherein each of the at least two radially extending features include lobes which are radially offset from one another”. This limitation is directed to new matter. There is no support for lobes which are “radially offset” from one another. The specification only discloses lobes can be “angularly offset” and never discloses that the lobes can be “radially offset” as claimed. A radial direction is a direction that extends between a central point and a radius of a circle. For the lobes to be “radially offset from one another” there would have to be lobes extending outward from the central axis to different radial lengths. The specification does not discuss different radial lengths of the lobes and the figures show all lobes having the same length measured from the center. Based on some of applicant’s arguments, it appears applicant may be equating angular offset with radial offset but such a comparison is incorrect since angles and radii are different.
Applicant argues Wahab in view of Taylor and Münder fails to teach or suggest the new limitation. Applicant argues that because the grooves of Wahab are uniform, uninterrupted circumferential features, they cannot possess “angularly offset lobes”. It is true that Wahab does not disclose lobes as claimed, but the examiner notes that the claim actually says the lobes are “radially offset” which is not the same as angularly offset.
Applicant argues “Taylor does not teach or suggest that the lobes of a first annular fin are angularly (radially) offset from the lobes of a second annular fin”. As noted above, radially offset and angularly offset are not the same. Also, claim 68 does not compare lobes of a first annular fin to lobes of a second annular fin. Claim 68 actually only requires “lobes which are radially offset from one another”. This could be any two lobes and is not required to be lobes of a first annular fin compared to lobes of a second annular fin. Applicant notes that Taylor focuses on varying the size and shape of dimples to adjust flow and flexural characteristics, not on rotational offsetting of lobes between successive fin rows. This argument is not commensurate in scope with what is actually claimed in claim 68. Claim 68 does not require rotational offsetting of lobes between successive fin rows. Based on applicant’s arguments, it seems that applicant intended to require an angular offset of lobes in different rows similar to what is claimed in claim 86. The rejection of claim 86 relied on teachings of de Beaubien which teaches 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 for the purpose of allowing an agent to flow more freely within the bone. Therefore, even if claim 68 was amended to recite lobes in line with applicant’s arguments, such lobes are taught by de Beaubien.
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.
Claims 68-87 are 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 claims contain 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 68 requires each of the at least two radially extending features include lobes which are radially offset from one another. There is no support for lobes which are “radially offset” from one another. The specification only discloses lobes can be “angularly offset” and never discloses that the lobes can be “radially offset” as claimed. A radial direction is a direction that extends between a central point and a radius of a circle. For the lobes to be “radially offset from one another” there would have to be lobes extending outward from the central axis to different radial lengths. The specification does not discuss different radial lengths of the lobes and the figures show all lobes having the same length measured from the center. Therefore, lobes which are radially offset from one another is new matter.
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 translation for passages referenced herein) in view of Taylor et al. US 2015/0272741 (hereafter referred to as Taylor) and in further view of Münder DE10128234A1 (hereafter referred to as Münder; refer to the 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 two 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 each radially extending feature includes lobes which are radially offset from one another, 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 two 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 at least two radially extending features 40 extending orthogonal to the central axis, wherein each radially extending feature includes lobes (figs. 3A-3D show lobes between dimples 46) for the purpose of decreasing the stiffness of the fins 40 and allowing the fins to flex in response to an axial load or force (par.34), and 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 radially extending features of Wahab to include lobes as taught by Taylor in order to decrease the stiffness of the radially extending features and allow them to flex. Regarding the lobes being radially offset from one another, applicant has not disclosed that this feature provides an advantage, is used for a particular purpose, or solves a stated problem (since the limitation is new matter and was not disclosed in the specification), therefore the radial offset is considered an obvious matter of design choice since the radial offset of lobes was not disclosed as being critical to the practice of the invention. It would have been further obvious 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). 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). 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). 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.
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 MEGAN Y WOLF whose telephone number is (571)270-3071. The examiner can normally be reached Mon-Fri 8am-2pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MEGAN Y WOLF/Primary Examiner, Art Unit 3774
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