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 5/26/2026 have been considered but are moot in view of the new grounds of rejection necessitated by the amendments.
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 1-4, 14, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McKay et al. US 7,285,135 (hereafter referred to as McKay).
Regarding claim 1, McKay discloses an orthopedic implant (figs. 30-31), comprising an elongated member 124 having a first end (right side in fig.30) and a second end (left side in fig.30) opposite the first end, wherein the elongated member is tapered at the second end such that a width of the second end is less than a width of the first end (see fig.30 which shows the second/left side/end is less wide in the vertical direction than the first/right side/end), a first channel 117 positioned on a first side of the elongated member and extending from the first end to the second end (figs.30-31; “end” is considered portion/region not an edge and each channel extends from the left end to the right end), a second channel 119 positioned on a second side of the elongated member and extending from the first end to the second end (fig.31), a bridge 112 positioned between the first channel and the second channel (fig.31), wherein the bridge at least partially defines the first channel and the second channel (the bridge forms the innermost surface of each channel), and one or more through holes 120 defined in the bridge, wherein the one or more through holes connect the first channel to the second channel (figs.30-31).
Regarding claim 2, see the plurality of holes 120 in figs.30-31.
Regarding claim 3, see figs.30-31 for the channels 117, 119 being recessed in the sides of the elongated member.
Regarding claim 4, see col.13, lines 49-63 for at least titanium and bone.
Regarding claim 14, see the threads on the top and bottom of the implant in figs.30-31.
Regarding claim 15, see col.13, lines 60-63 for a bioresorbable material such as PLA.
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 1-5, 14, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Morris et al. US 2018/0280589 (hereafter referred to as Morris) in view of McKay.
Regarding claims 1 and 5, Morris discloses an orthopedic implant 100 for use as an inter-vertebral implant (figs. 3-4) wherein at least a portion of an exterior surface includes a cured osteostimulative material 106 (par.33). Morris discloses the invention substantially as claimed, but Morris does not disclose that the vertebral implant comprises an elongated member having a first end and a second end opposite the first end, wherein the elongated member is tapered at the second end such that a width of the second end is less than a width of the first end, a first channel positioned on a first side of the elongated member and extending from the first end to the second end, a second channel positioned on a second side of the elongated member and extending from the first end to the second end, a bridge positioned between the first channel and the second channel, wherein the bridge at least partially defines the first channel and the second channel, and one or more through holes defined in the bridge, wherein the one or more through holes connect the first channel to the second channel.
McKay teaches an orthopedic implant (figs. 30-31), in the same field of endeavor, wherein the orthopedic implant is a vertebral implant comprising an elongated member 124 having a first end (right side in fig.30) and a second end (left side in fig.30) opposite the first end, wherein the elongated member is tapered at the second end such that a width of the second end is less than a width of the first end (see fig.30 which shows the second/left side/end is less wide in the vertical direction than the first/right side/end), a first channel 117 positioned on a first side of the elongated member and extending from the first end to the second end (figs.30-31; “end” is considered portion/region not an edge and each channel extends from the left end to the right end), a second channel 119 positioned on a second side of the elongated member and extending from the first end to the second end (fig.31), a bridge 112 positioned between the first channel and the second channel (fig.31), wherein the bridge at least partially defines the first channel and the second channel (the bridge forms the innermost surface of each channel), and one or more through holes 120 defined in the bridge, wherein the one or more through holes connect the first channel to the second channel (figs.30-31). The vertebral implant of McKay is designed to support bone growth material within the intervertebral space while still maintaining the normal height of the disc space, and beneficially eliminates the risk of stress-shielding and provides for visualization of a fusion mass as the arthrodesis progresses (col.2, lines 47-53).
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 vertebral implant comprising osteostimulative material of Morris to include the structure of the vertebral implant taught by McKay including a tapered shape, two opposite channels, and a bridge with holes connecting the two channels in order to support bone growth within the intervertebral space while eliminating the risk of stress-shielding and allowing for visualization of bone growth as the arthrodesis progresses.
Regarding claim 2, see the plurality of holes 120 in McKay figs.30-31.
Regarding claim 3, see McKay figs.30-31 for the channels 117, 119 being recessed in the sides of the elongated member.
Regarding claim 4, see Morris par.31 for each of the claimed materials.
Regarding claim 14, see the threads on the top and bottom of the implant in figs.30-31 of McKay.
Regarding claim 15, Morris does not disclose that the elongated member is resorbable. However, McKay teaches the implant can be made from a bioresorbable material such as PLA (McKay col.13, lines 60-63). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to form the elongated body of Morris from a resorbable material as taught by McKay in order to allow for the implant to be absorbed and replaced with bone if desired and since it has been held that selection of a known material based on its suitability for an intended use is an obvious extension of prior art teaching (In re Leshin 227 F.2d 197, 125 USPQ 416 (CCPA 1960) MPEP 2144.07).
Claims 6-8 and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Morris in view of McKay as applied to claim 5 above, and further in view of Diaz et al. US 2019/0125420 (hereafter referred to as Diaz).
Regarding claim 6, Morris in view of McKay discloses the orthopedic implant of claim 5 as discussed above. In par.39, Morris further teaches a cured osteostimulative material similar to the material of claim 6, but Morris does not disclose the cured osteostimulative material further comprises poly-lactic acid and magnesium phosphate.
Diaz teaches an orthopedic implant, in the same field of endeavor, wherein poly-lactic acid and magnesium phosphate are used as an implant material for their biodegradable and bioactive properties (par.24).
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 cured osteostimulative material of Morris to include poly-lactic acid and magnesium phosphate as taught by Diaz since Diaz teaches poly-lactic acid and magnesium phosphate are suitable bioabsorbable and bioactive materials for stimulating bone growth and since it has been held that selection of a known material based on its suitability for an intended use is an obvious extension of prior art teaching (In re Leshin 227 F.2d 197, 125 USPQ 416 (CCPA 1960) MPEP 2144.07).
Regarding claim 7, see Diaz par.24 for at least PLLA.
Regarding claim 8, Morris teaches therapeutic agents including antibiotics in par.35.
Regarding claim 11, see Morris par.30 for a coating thickness of 20-200 microns. While Morris does not specifically disclose a thickness of 200 microns to 50 mm, the range disclosed by Morris overlaps the claimed range, and it has been held that where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists (MPEP 2144.05I). Further, 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 12, see Morris par.33 and fig.3 for the osteostimulative material 106 positioned in one or more of a plurality of grooves/valleys. Also see McKay figs. 30-31 which show grooves between the threads. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the osteostimulative material of Morris in the plurality of grooves of the implant taught by McKay in order to stimulate bone growth at the bone contacting surface of the implant.
Regarding claim 13, Morris does not disclose that the entirety of the elongated member comprises the cured osteostimulative material. However, Diaz teaches the entirety of the implant comprises a cured osteostimulative material (the PLA and magnesium/potassium phosphate as well as an added osteostimulative material) for the purpose of allowing the implant to be fully absorbed and replaced by bone (par.25). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to form the elongated body of Morris in view of McKay entirely from the resorbable cured osteostimulative material as taught by Diaz in order to allow for the implant to be fully absorbed and replaced with bone resulting in no void being left behind.
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Morris in view of McKay and Diaz as applied to claims 6 and 8 above, and further in view of Lally US 2015/0314045 (hereafter referred to as Lally).
Regarding claim 9, Morris in view of McKay and Diaz discloses the implant of claim 8, wherein Morris specifically disclosing antibiotics, but Morris in view of McKay and Diaz does not disclose any particular antibiotics as claimed in claim 9.
Lally teaches a bone implant material, in the same field of endeavor, wherein the material may include antibiotics such as amikacin, butirosin, dideoxykanamycin, fortimycin, gentamycin, kanamycin, lividomycin, neomycin, netilmicin, ribostamycin, sagamycin, seldomycin and epimers thereof, sisomycin, sorbistin, spectinomycin and tobramycin (par.71).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select one of the known antibiotics taught by Lally for the antibiotic of Morris in view of McKay and Diaz since it has been held that selection of a known material based on its suitability for an intended use is an obvious extension of prior art teaching (In re Leshin 227 F.2d 197, 125 USPQ 416 (CCPA 1960) MPEP 2144.07).
Regarding claim 10, Morris in view of McKay and Diaz discloses the implant of claim 6 as discussed above. Morris further discloses the cured osteostimulative material comprises a sugar (Morris par. 55 and claim 8), but Morris in view of McKay and Diaz does not disclose a particular type of sugar wherein the sugar comprises one of sugar alcohols, sugar acids, amino sugars, sugar polymers glycosaminoglycans, glycolipids, sugar substitutes and combinations thereof.
Lally teaches a bone implant material, in the same field of endeavor, wherein the material may include sugars such as sucrose, sugar alcohols, sugar acids, amino sugars, sugar polymers glycosaminoglycans, glycolipids, sugar substitutes (par.55) for the purpose of enhancing osteoproliferative properties and adhesive capabilities (par.54).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select one of the known types of sugars taught by Lally for the sugar of Morris in view of McKay and Diaz since it has been held that selection of a known material based on its suitability for an intended use is an obvious extension of prior art teaching (In re Leshin 227 F.2d 197, 125 USPQ 416 (CCPA 1960) MPEP 2144.07).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Gorek US 2008/0262621 discloses a tapered implant comprising two channels, a bridge, and holes through the bridge (figs. 4-7). Kohrs US 6,224,631 discloses an implant comprising two channels, a bridge, and holes through the bridge (fig.8).
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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/MEGAN Y WOLF/Primary Examiner, Art Unit 3774
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