DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . This action is responsive to the amendments received after a Non-Final Rejection on 15 December 2025. Claims 1-19 are currently pending.
Claim Objections
Claim 1 is objected to because of the following informality:
In line 7, it appears that the phrase “the wedge-shaped implant” should read “the wedge-shaped member.”
Claim 14 is objected to because of the following informality:
In line 3, it appears that the phrase “the conformation” should read “a conformation.”
In line 3, it appears that the phrase “the osteotomy” should read “an osteotomy.”
Appropriate correction is required.
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 1-3, 11-15 and 18-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cachia (U.S. Patent Application Publication 2005/0197711).
Regarding claims 1-3 and 11-12, Cachia discloses (as to claim 1) a mid-foot osteotomy molding device (see Figure 21E) comprising a wedge-shaped member (78, see paragraph 0118) made of at least a partially resorbable conformable material (see paragraphs 0120-0122 referring to the use of resorbable securing structures), the wedge-shaped member being capable of being placed between adjacent mid-foot bones post-osteotomy (see Note below regarding functional language) and conforming to a space between the adjacent mid-foot bones post-osteotomy (see paragraphs 0112 and 0114), the wedge-shaped member has an internal inflation chamber (i.e. chamber not shown, but similar to 64) capable of receiving a fluid (see paragraphs 0127-0128) therein, wherein introduction of the fluid into the internal inflation chamber expands the wedge-shaped member from a pre-implant angle (not shown, but see paragraph 0117 referring to the device being compressible onto a catheter) to a post-implant angle (see Figure 21E and paragraph 0117 referring to the device assuming a preconfigured shape with inflation), the post-implant angle is capable of approximating a post-implant correction of the adjacent mid-foot bones (see Note below regarding functional language and paragraphs 0103-0108 referring to the device being used to correct bones), wherein the fluid is a conformable and moldable material (e.g. PMMA, see paragraph 0128) and the wedge-shaped member is capable of conforming to the space between the adjacent mid-foot bones (see Note below regarding functional language and paragraphs 0103-0108 referring to the device being used to correct bones), wherein (as to claim 2) the fluid is capable of hardening within the internal inflation chamber and molding the wedge-shaped member to a conformation of the osteotomy (see Note below regarding functional language and paragraph 0128), wherein (as to claim 3) the wedge-shaped member is capable of being fabricated of a biocompatible material selected from the group consisting of metal, ceramic, composites, polymer, or a synthetic bone growth matrix or combinations thereof (see paragraph 0124), wherein (as to claim 11) the fluid further comprises a bone cement (e.g. PMMA, see paragraph 0128), and wherein (as to claim 12) the bone cement is polymethylmethacrylate (see paragraph 0128) (see Figures 20A-20B and 21E, and paragraphs 0113-0118, 0124 and 0134).
Regarding claims 13-15 and 18-19, Cachia discloses (as to claim 13) a mid-foot osteotomy implant device (see Figure 21E) comprising a conformable wedge-shaped member (78, see paragraphs 0112, 0114 and 0118) having an internal inflation chamber (i.e. chamber not shown, but similar to 64) capable of receiving a conformable and moldable fluid (e.g. PMMA, see paragraphs 0127-0128) therein that expands the wedge-shaped member from a pre-implant angle (not shown, but see paragraph 0117 referring to the device being compressible onto a catheter) to a post-implant angle (see Figure 21E and paragraph 0117 referring to the device assuming a preconfigured shape with inflation), the post-implant angle is capable of approximating a post-implant correction of adjacent mid-foot bones (see Note below regarding functional language and paragraphs 0103-0108 referring to the device being used to correct bones) and conforming the wedge-shaped member to a space between the adjacent mid-foot bones (see Note below regarding functional language and paragraphs 0103-0108 referring to the device being used to correct bones), wherein (as to claim 14) the fluid is capable of hardening within the internal inflation chamber and molding the wedge-shaped member to a conformation of the osteotomy (see Note below regarding functional language and paragraph 0128), wherein (as to claim 15) the wedge-shaped member is capable of being fabricated of a biocompatible material selected from the group consisting of metal, ceramic, composites, polymer, or a synthetic bone growth matrix or combinations thereof (see paragraph 0124), wherein (as to claim 18) the fluid further comprises a bone cement (e.g. PMMA, see paragraph 0128), and wherein (as to claim 19) the bone cement is polymethylmethacrylate (see paragraph 0128) (see Figures 20A-20B and 21E, and paragraphs 0113-0118, 0124 and 0134).
Note: Regarding functional language, "[a]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) (see MPEP 2114(II)).
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 4-6, 8-10 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Cachia (U.S. Patent Application Publication 2005/0197711), as applied to claims 1, 3 and 15 above respectively, in view of Marik (U.S. Patent 8,518,114).
Regarding claims 4-6 and 8-10, Cachia discloses the claimed invention except for wherein (as to claim 4) the metal is selected from the group consisting of shape memory alloys, stainless steel, cobalt-based alloys, and titanium, wherein (as to claim 5) the metal is a porous metal, wherein (as to claim 6) the device is capable of further comprising a surface treatment that imparts osteophilic bone growth sites to the biocompatible material, wherein (as to claim 8) the synthetic bone growth matrix is selected from the group consisting of hydroxyapatite, tricalcium phosphate, calcium sulfate, or combinations thereof, wherein (as to claim 9) the polymer further comprises a resorbable polymer selected from the group of polylactides, polyglycolides, polycaprolactone, cellulose, chitosan, collagen, hyaluronan, fibrin, or combinations thereof, and wherein (as to claim 10) the wedge-shaped member is capable of being fabricated of shape memory or superelastic nickel-titanium based alloy.
Marik teaches the use of an osteotomy device (10) having a wedge shape (i.e. shape as best seen in Figure 17) capable of being placed between adjacent bones post-osteotomy (see Note above regarding functional language), wherein the device is capable of being fabricated of a biocompatible material selected from the group consisting of metal, ceramic, composites, polymer, or a synthetic bone growth matrix (see column 4, line 35 – column 5, line 12), wherein the metal is selected from the group consisting of shape memory alloys, stainless steel, cobalt-based alloys, and titanium (see column 4, line 35 – column 5, line 12), wherein the metal is a porous metal (e.g. titanium, see column 4, line 35 – column 5, line 12), wherein the osteotomy device is capable of further comprising a surface treatment that imparts osteophilic bone growth sites to the biocompatible material (see column 9, lines 24-38), wherein the synthetic bone growth matrix is selected from the group consisting of hydroxyapatite, tricalcium phosphate, calcium sulfate (see column 4, line 35 – column 5, line 12), wherein the polymer further comprises a resorbable polymer selected from the group consisting of polylactides, polyglycolides, polycaprolactone, cellulose, chitosan, collagen, hyaluronan, fibrin (see column 4, line 35 – column 5, line 12), and wherein the device is capable of being fabricated of shape memory or superelastic nickel-titanium based alloy (see column 4, line 35 – column 5, line 12) (see Figures 1-19, and column 4, line 25 – column 10, line 26).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the invention of Cachia with wherein the metal is selected from the group consisting of shape memory alloys, stainless steel, cobalt-based alloys, and titanium, wherein the metal is a porous metal, wherein the device is capable of further comprising a surface treatment that imparts osteophilic bone growth sites to the biocompatible material, wherein the synthetic bone growth matrix is selected from the group consisting of hydroxyapatite, tricalcium phosphate, calcium sulfate, or combinations thereof, wherein the polymer further comprises a resorbable polymer selected from the group of polylactides, polyglycolides, polycaprolactone, cellulose, chitosan, collagen, hyaluronan, fibrin, or combinations thereof, and wherein the wedge-shaped member is capable of being fabricated of shape memory or superelastic nickel-titanium based alloy in view of Marik in order to provide alternative, well-known and obvious biocompatible materials for desired material characteristics to yield predictable results. Furthermore, it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice (In re Leshin, 125 USPQ 416).
Regarding claims 16 and 17, Cachia discloses the claimed invention except for wherein (as to claim 16) the device is capable of further comprising a surface treatment that imparts osteophilic bone growth sites to the biocompatible material, and wherein (as to claim 17) the wedge-shaped member is capable of being fabricated of shape memory or superelastic nickel-titanium based alloy.
Marik teaches the use of an osteotomy device (10) having a wedge shape (i.e. shape as best seen in Figure 17) capable of being placed between adjacent bones post-osteotomy (see Note above regarding functional language), wherein the device is capable of being fabricated of a biocompatible material selected from the group consisting of metal, ceramic, composites, polymer, or a synthetic bone growth matrix (see column 4, line 35 – column 5, line 12), wherein the osteotomy device is capable of further comprising a surface treatment that imparts osteophilic bone growth sites to the biocompatible material (see column 9, lines 24-38), and wherein the device is capable of being fabricated of shape memory or superelastic nickel-titanium based alloy (see column 4, line 35 – column 5, line 12) (see Figures 1-19, and column 4, line 25 – column 10, line 26).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the invention of Cachia with wherein the device is capable of further comprising a surface treatment that imparts osteophilic bone growth sites to the biocompatible material, and wherein the wedge-shaped member is capable of being fabricated of shape memory or superelastic nickel-titanium based alloy in view of Marik in order to provide alternative, well-known and obvious biocompatible materials for desired material characteristics to yield predictable results. Furthermore, it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice (In re Leshin, 125 USPQ 416).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Cachia (U.S. Patent Application Publication 2005/0197711), as applied to claim 3 above, in view of Suh et al. (U.S. Patent Application Publication 2015/0320570).
Cachia discloses the claimed invention except for wherein the ceramic is selected from the group consisting of alumina, zirconia, alumina composites, or oxidized zirconium composites.
Suh et al. teach the use of a biocompatible implant (e.g. 710) fabricated of a biocompatible material, wherein the biocompatible material is alumina, or zirconia (see paragraph 0130).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the invention of Cachia with wherein the ceramic is selected from the group consisting of alumina, zirconia, alumina composites, or oxidized zirconium composites in view of Suh et al. in order to provide a desired material providing a desired material characteristic to yield predictable results. Furthermore, it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice (In re Leshin, 125 USPQ 416).
Response to Arguments
Applicant’s arguments with respect to claims 1-19 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 LARRY E WAGGLE, JR whose telephone number is (571)270-7110. The examiner can normally be reached TEAP: Monday - Friday (7:45am - 3:45pm).
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/LARRY E WAGGLE, JR/Primary Examiner, Art Unit 3775