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 Objections
Claim 15 is objected to because of the following informalities: In line 4, “second dimension” is believed to be in error for --second depth dimension--. Appropriate correction is required.
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 16 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. The specification as originally filed does not disclose the first depth dimension is different than the second depth dimension as claimed in claim 16. (Note that the claims filed 8/7/2024 were filed after the effective filing date of the application.) Par.35 of the specification as originally filed states that “flange 240A is representative of flanges 240A-D, with the exception of different orientations of the flanges”. This provides support for claim 15 which requires that the first depth dimension is equal to the second dimension since par.35 says flange 240A is representative of all of the shown flanges. Figures 6-8 of the instant application (all claims are directed to figures 6-8) do not definitively show different flange depth dimensions and therefore cannot be relied upon for support of claim 16.
Claim Rejections - 35 USC § 102
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.
Claims 1, 2, 4, 5, and 7-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gunther et al. US 2010/0249938 (hereafter referred to as Gunther).
Regarding claim 1, Gunther discloses a glenoid implant (fig.45) for use in a glenoid of a shoulder joint comprising: a body with a bearing surface 14 and a bone-contacting surface 16 opposite the bearing surface, the body extending from a superior end to an inferior end (fig.45; the body is circular and inherently has a superior end and inferior end depending on its use); and a plurality of spaced-apart flanges 130 each extending from the bone-contacting surface of the body, a first flange of the plurality of flanges extending from the bone-contacting surface of the body to a first free end, the first flange including a first inside facing surface that faces a center of the body and a first outside facing surface that faces an outer perimeter of the body, the first outside facing surface being separated from the first inside facing surface by a first side surface and second side surface of the first flange (see annotated fig.45 below), each of the first inside and outside facing surfaces extending from the bone-contacting surface to the first free end (end opposite bone contacting surface end), wherein the first outside facing surface includes an elongate dimension (the circumferential dimension of the flanges are elongate) extending from the first side surface to the second side surface, wherein the elongate dimension is aligned with a portion of the outer perimeter of the body at the bone-contacting surface (fig.45 shows each of these features for each of flanges 130; “aligned with” is broad and interpreted to mean in agreement/coordination with; the flanges are parallel to the perimeter of the body and therefore aligned with the perimeter of the body).
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Regarding claim 2, see fig.45 for the elongate circumferential dimension being greater than a depth of the flange.
Regarding claims 4 and 5, see fig.45 for each flange having an arcuate shape in the circumferential direction and a tapered outside surface.
Regarding claim 7, par.162 discloses an external diameter F of the flanges is 10 mm to 20 mm. This means that each of the four flanges have an elongate dimension within the range of 5 mm to 15 mm.
Regarding claim 8, the flanges of fig.45 lie on a circle and are therefore symmetrical.
Regarding claim 9, fig.45 shows four flanges. Any two opposite flanges can be considered superior and inferior.
Claim 11-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jones et al. US 2007/0219638 (hereafter referred to as Jones).
Regarding claim 11, Jones discloses glenoid implant 1 for use in a shoulder joint (fig.7) comprising: a body 1 with an inner surface 3 and an outer surface 2 opposite the inner surface, the inner surface being adapted for engagement with a first native or prosthetic bone of the shoulder joint, and the outer surface being adapted to articulate with a second native or prosthetic bone of the shoulder joint (par.61; figs.3-4); a plurality of flanges 8, 9, 12, 13 including a first flange 8 and a second flange 12, each flange of the plurality of flanges extending from the inner surface of the body (figs. 3-4), the first flange 8 having a first outside facing surface (superior surface) that faces an outer perimeter of the body, wherein the first outside facing surface includes a first radius of curvature aligned with (corresponding with) a second radius of curvature of a first portion of the outer perimeter of the body (fig.4), the second flange 12 having a second outside facing surface that faces the outer perimeter of the body, wherein the second outside facing surface includes a third radius of curvature aligned with a fourth radius of curvature of a second portion of the outer perimeter of the body (fig.4 shows the flange 12 aligned with the outer perimeter of the body, both having a slight curvature), wherein the first flange 8 is disposed on a superior-most end of the inner surface (par.71), the second flange is disposed on an anterior-most end of the body (par.72), wherein the first radius of curvature of the first outside facing surface is less than the third radius of curvature of the second outside facing surface (fig.4 shows the superior flange 8 has a smaller radius of curvature than the anterior flange 12).
Regarding claims 12 and 13, see fig.4 for third flange 9 disposed on the inferior-most end of the body and fourth flange 13 disposed on the posterior most end of the body. Flanges 8 and 9 have smaller radius of curvatures than flanges 12 and 13.
Regarding claim 14, see figs.3-4 for the tapered outer surface of the first flange at least where the surface rounds.
Claims 17 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Long US 2012/0130499 (hereafter referred to as Long).
Regarding claim 17, Long discloses an implant (fig.9) for use in a mammalian joint comprising: a body 10 with a joint facing surface (joint facing surface of 14 in fig.5) and a bone facing surface (bone facing surface of 12), the body having a length extending from a superior end to an inferior end (fig.5); a plurality of flanges 54 including a first flange (either the most anterior flange or most posterior flange) and a second flange (the other of the most anterior or posterior flanges), each flange of the plurality of flanges extending from the bone facing surface of the body (fig.9), the first flange having a first depth extending from a first base at the bone facing surface of the body to a first free end, wherein the first flange includes a first outside surface that faces an outer perimeter of the body, wherein the first outside surface of the first flange is curved to have a first elongate dimension aligned with a first portion of an outer perimeter of the body (see annotated fig.9 below), and the second flange having a second depth extending from a second base at the bone facing surface of the body to a second free end, wherein the second flange includes a second outside surface that faces the outer perimeter of the body, wherein the second outside surface of the second flange is curved to have a second elongate dimension aligned with a second portion of the outer perimeter of the body, wherein the first elongate dimension is different from the second elongate dimension (see annotated fig.9 below).
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Regarding claim 19, see fig. 9 which shows the flange elongate dimensions are greater than the depth of the flanges.
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.
Claims 3 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Gunther.
Regarding claim 3, Gunther discloses the glenoid implant of claim 1 as discussed above. Gunther does not specifically disclose that the first outside facing surface of the first flange at the bone-contacting surface is between 2 mm and 6 mm from the outer perimeter of the body. However, Gunther does give an example of a 31 mm diameter body (par.146) and says the diameter is generally 20-55 mm (par.147). Gunther also discloses that the flanges have an outer diameter F of 10-20 mm (par.162). Therefore, when the diameter of the body is 31 mm and the diameter of the flanges is 20 mm, the flanges are spaced 5.5 mm from the outer perimeter. As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the example diameter of 31 mm for the body and a flange outer diameter of 20 mm since Gunther discloses these values are suitable for the glenoid prosthesis dimensions. It would have been further obvious to choose other diameters that yield the claimed spacing since Gunther teaches these diameters are suitable for a glenoid prosthesis and because it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), MPEP 2144.05 II A).
Regarding claim 10, Gunther discloses the glenoid implant of claim 1 as discussed above. Gunther does not specifically disclose that the depth of the first flange is within a range from 2 mm to 10 mm, however, Gunther does disclose that the pin has a length (which is equivalent to the claimed depth) of less than about 8 mm (par.123). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select a depth of the first flange within a range from 2 mm to 10 mm since Gunther teaches less than 8 mm and since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), MPEP 2144.05 II A).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Gunther as applied to claim 1 above, and further in view of Ferro et al. US 2017/0312084 (hereafter referred to as Ferro). Gunther discloses the glenoid implant of claim 1 as discussed above, but Gunther does not disclose a thickness of the flange at the bone-contacting surface of 0.75-1.75 mm or a thickness at the free end of 0.25-1mm.
Ferro teaches a shoulder implant (par.62), in the same field of endeavor, wherein the thickness of a flange at a bone-contacting surface is between about 0.5 mm and about 2.5 mm (par.76) and the thickness of the flange at the free end is less than 0.5 mm (par.84) for the purpose of digging into bone to achieve a rigid fixation and total contact of the implant device with bone (par.60).
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 thickness of the flanges of Gunther to have thickness at the base of 0.75-1.75 mm and a thickness at the free end of 0.25-1 mm since Ferro teaches values within these ranges are ideal for achieving rigid fixation of bone. While Ferro does not disclose the exact claimed ranges, it would have been obvious to select thicknesses in the claimed ranges since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), MPEP 2144.05 II A).
Claims 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Jones as applied to claim 11 above, and further in view of Ferro. Jones discloses the glenoid implant of claim 14 as discussed above. However, Jones does not disclose that the second outside facing surface of the second flange 12 is tapered along a second depth dimension extending from the inner surface of the body to a second free end of the second flange.
Ferro teaches a shoulder implant (par.62), in the same field of endeavor, wherein outer flange surfaces are tapered for the purpose of digging into bone to achieve a rigid fixation and total contact of the implant device with bone (par.60; figs. 7-12).
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 second flange of Jones to include a tapered outer surface as taught by Ferro in order to dig into bone to achieve a rigid fixation and total contact of the implant device with bone. Jones shows different depths for the first and second flanges in figs. 3-4 and 7. Ferro teaches equal depths for flanges in at least figs. 20. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select either equal or different depths for the flanges of Jones as a matter of design choice since these features were not disclosed as being critical to the practice of the invention (the equal/different depths are not addressed at all in the specification of the instant application). Applicant has not disclosed that either depth design provides an advantage, is used for a particular purpose, or solves a stated problem and one of ordinary skill in the art would have expected the glenoid implant of Jones to function equally well with either equal or different flange depths since both designs perform the same function of anchoring the implant in bone. Therefore, it would have been prima facie obvious to modify Jones in view of Ferro to obtain the invention as specified in claims 15 and 16 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Jones and Ferro.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Long. Long discloses the implant of claim 17 as discussed above. Long does not specifically disclose first and second elongate dimensions within a range of 5 mm to 15 mm, but Long does disclose selecting an augment size depending on the patient’s anatomy (par.41). Therefore, 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 augments/flanges taught by Long, if necessary, to include first and second elongate dimensions in the range from 5 mm to 15 mm depending on the needs of the patient. For instance, if the patient has a small defect, a smaller elongate dimension may be used and if the patient has a larger defect, a larger elongate dimension may be used.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Long as applied to claim 17 above, and further in view of Anthony et al. US 2011/0213371 (hereafter referred to as Anthony). Long discloses the implant of claim 17 as discussed above, but Long does not specifically disclose that the first and second depth are each within a range from 2 mm to 10 mm.
Anthony teaches a glenoid implant, in the same field of endeavor, wherein a 3 mm, 5 mm, or 7 mm thick augment is selected for the purpose of filling a bone defect (par.91; fig.1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select an augment/flange depth for the implant of Long to be 3 mm, 5 mm, or 7 mm as taught by Anthony, depending of the size of the glenoid defect.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Hodorek et al. US 2020/0188125 discloses a circular glenoid implant with three equally sized curved flanges (figs. 10-14). Burkhead et al. US 4,964,865 discloses a glenoid implant comprising a wider inferior end than superior end and a flange 316 extending from a bone facing surface (figs.16-17).
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/MEGAN Y WOLF/Primary Examiner, Art Unit 3774
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