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 Amendment
This Office Action is responsive to the amendment filed on 11 March 2026. As directed by the amendment: Claims 19, 21, and 32 have been amended, and claims 1-18 and 28 are cancelled. Claims 19-27 and 29-36 currently stand pending in the application.
The amendments to the claims have resolved the claim objections listed in the previous action, which are correspondingly withdrawn. However, further claim objections are detailed below.
Response to Arguments
Applicant’s arguments with respect to the rejections under 35 U.S.C. 102(a)(1)/(2) as anticipated by U.S. Patent No. 5,743,913 to Wellisz have been considered but are moot because the new ground of rejection does not rely on any interpretation of the reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The center of curvature of the arc shape in both interpretations of Wellisz below is on an opposite, outer side of the at least one frame as the adaptation area, which is on an inner side of the at least one frame.
Claim Objections
Claim 23 is objected to because of the following informalities: improper antecedence. Appropriate correction is required. The following amendments are suggested:
Claim 23 / lines 2-3: “a lattice structure dimensionedand configured to be deformed”
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 19-27 and 29-36 are rejected under 35 U.S.C. 112(a) 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.
As to claim 19, the limitation of “at least one frame with a substantially uniform thickness” (line 2) is not supported by the specification as originally filed. Although the specification recites different possible thicknesses of the adaptation area, the specification does not make mention of the thickness of the at least one frame, much less that the thickness of the frame is substantially uniform. The terms uniform or substantially uniform are not found in the specification.
As to claim 32, the limitation “wherein at least one attachment tab is dimensioned like the at least one frame and has a bendability that corresponds to the at least one frame” (lines 3-4) is not supported by the specification as originally filed. The specification does not recite that the attachment tabs are dimensioned like the at least one frame, nor that the attachment tabs have a bendability that corresponds to the at least one frame.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 32 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
As to claim 32, the limitation “at least one attachment tab” (line 3) renders the claim indefinite, because it is unclear if this refers back to the previously recited at least one attachment tab of claim 30, to one or all of the at least one attachment tab of claim 30, or to a different at least one attachment tab. For examination purposes, the limitation will be interpreted as the at least one attachment tab.
Further as to claim 32, the limitation that “wherein at least one attachment tab is dimensioned like the at least one frame and has a bendability that corresponds to the at least one frame” (lines 3-4) renders the claim indefinite, because the scope of “dimensioned like” and “corresponds to” are unclear. For examination purposes, the limitation will be interpreted under broadest reasonable interpretation. Examiner notes that “dimensioned like” does not require the same dimensions, and “a bendability that corresponds to” does not require the same bendability, only that they have bendabilities that somehow correspond, e.g. are compatible.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 19-25, 27, and 29-36 are rejected under 35 U.S.C. 102(a)(1)/(2) as anticipated by U.S. Patent No. 5,743,913 to Wellisz.
As to claim 19, Wellisz discloses an implant for the treatment of bone, comprising: at least one frame (20 on the left in FIG. 1, up to the node 12 at its top end as labelled in the figure, and 20 on the right in FIG. 1, up to the node 12 at its top end as labelled in the figure) with a substantially uniform thickness (col. 2 / lines 64-67, col. 3 / lines 41-42), FIG. 1; and at least one adaptation area (one interior node 12 with its surrounding ribs 17) (col. 2 / lines 46-63); wherein the at least one frame is arranged outside the at least one adaptation area, and has a smaller bendability than the at least one adaptation area (since the frame comprises a solid and primarily wider structure and the adaptation area comprises thinner ribs with a greater bendability, so that the frame has on average a smaller bendability), and partially forms an outer edge of the implant, FIG. 1, wherein the at least one frame does not continuously delimit the outer edge of the implant, so that at least one region (regions at 28 and superior 20) of the outer edge is not delimited by the at least one frame, and wherein the at least one frame has an arc shape (seen in the concave curvature of each 20 at the superior end where it extends toward the respective 12), the arc shape being curved inwardly toward the at least one adaptation area, so that a center of curvature of the arc shape and the at least one adaptation area are located on opposite sides (outer side and inner side) of the at least one frame, such that the at least one frame is dimensioned and positioned to be attached to the margo supraorbitalis (interpreted as language of intended use; fully capable of being attached to the margo supraorbitalis, for example in the concavity of the margo supraorbitalis, and particularly since the frame is bendable to conform to any underlying or adjacent structure).
As to claim 20, Wellisz discloses the implant according to claim 19, wherein the at least one frame comprises at least two frames (20 on the left and 20 on the right), FIG. 1, wherein each of the at least two frames is arranged outside the at least one adaptation area and partially forms the outer edge of the implant, and the at least two frames do not continuously delimit the outer edge of the implant, so that the at least one region comprises at least two regions (regions at 28 and superior 20) of the outer edge that are not delimited by the at least two frames.
As to claim 21, Wellisz discloses the implant according to claim 19, wherein the at least one adaptation area is continuous and is free of frames inside of the outer edge, FIG. 1.
As to claim 22, Wellisz discloses the implant according to claim 19, wherein the at least one frame is dimensioned and arranged such that at least half of the outer edge is continuously not delimited by the at least one frame (28 and superior 20 comprise half of the outer edge), FIG. 1.
As to claim 23, Wellisz discloses the implant according to claim 19, wherein the at least one adaptation area comprises a lattice structure (col. 1 / lines 54-56; ribs 17 intersect at the node 12) dimensioned, such that it can be deformed by hand or with hand tools (col. 2 / lines 58-63).
As to claim 24, Wellisz discloses the implant according to claim 19, wherein the implant comprises a biocompatible material (col. 1 / lines 52-54).
As to claim 25, Wellisz discloses the implant according to claim 19, wherein the at least one adaptation area comprises connection areas (where each rib 17 connects to the node 12) dimensioned to be cut by means of hand tools (interpreted as language of intended use; the connection areas are fully capable of being cut by hand tools since they are spaced apart from adjacent structures).
As to claim 27, Wellisz discloses the implant according to claim 19, wherein the at least one frame is dimensioned and positioned to be attached (at least frictionally attached to bone, and/or integrally attached to the adaptation area).
As to claim 29, Wellisz discloses the implant according to claim 27, wherein the implant comprises two of the at least one frame (20 on the left and 20 on the right) adapted to the margo supraorbitalis (interpreted as language of intended use; fully capable of being adapted to the margo supraorbitalis, since the frames can be attached for example in the concavity of the margo supraorbitalis, and particularly since the frames are bendable to conform to any underlying or adjacent structure) and wherein the implant has, between the two frames, an intermediate region (28, which is intermediate or between the two frames) of the at least one region whose bendability is greater than that of the two frames (since the intermediate region 28 has narrower areas than the frames and is thus more bendable).
As to claim 30, Wellisz discloses the implant according to claim 19, wherein the implant comprises at least one attachment tab (superior 20), FIG. 1.
As to claim 31, Wellisz discloses the implant according to claim 30, wherein the at least one attachment tab is integrally connected to one of the at least one frame, FIG. 1.
As to claim 32, Wellisz discloses the implant according to one of claims 30, wherein the at least one attachment tab is adapted for attachment to the nasal bone (interpreted as language of intended use; fully capable of attachment to the nasal bone if positioned adjacently thereto since the attachment tabs and adaptation area are bendable to conform to the underlying bone structure), and wherein at least one attachment tab is dimensioned like the at least one frame (at least same dimension of thickness since the entire implant has a generally uniform thickness) and has a bendability that corresponds to (is at least similar to) the at least one frame (the frame and tab have similar widths so their bendabilities at least where these similar widths are measured would correspond).
As to claim 33, Wellisz discloses the implant according to claim 19, wherein the implant is adapted to cover defects or drill holes or to reconstruct bone defects or malformations at the sinus (interpreted as language of intended use; fully capable of any of these applications if positioned appropriately relative to the hole/defect and bended to conform to the surrounding bone).
As to claim 34, Wellisz discloses the implant according to claim 19, wherein the at least one adaptation area is formed integrally (with components of itself), FIG. 1.
As to claim 35, Wellisz discloses the implant according to claim 19, wherein the entire implant is formed integrally, FIG. 1.
As to claim 36, Wellisz discloses the implant according to any claim 19, wherein the at least one adaptation area is plastically deformable (col. 2 / lines 62-63).
As to claim 19, Wellisz discloses an implant for the treatment of bone, comprising: at least one frame (28) with a substantially uniform thickness (col. 3 / lines 11-20, col. 3 / lines 41-42), FIG. 1; and at least one adaptation area (interior area comprising nodes 12 and ribs 17) (col. 2 / lines 46-63); wherein the at least one frame is arranged outside the at least one adaptation area, and has a smaller bendability than the at least one adaptation area (since the frame comprises a wider structure and the adaptation area comprises narrower ribs with a greater bendability), and partially forms an outer edge of the implant, FIG. 1, wherein the at least one frame does not continuously delimit the outer edge of the implant, so that at least one region (outer edge of the rest of the implant apart from 28) of the outer edge is not delimited by the at least one frame, and wherein the at least one frame has an arc shape (arc shape between adjacent holes 32, on an outer edge of 28), the arc shape being curved inwardly toward the at least one adaptation area (a center of the concave arc shape is curved inwardly toward the at least one adaptation area), so that a center of curvature of the arc shape and the at least one adaptation area are located on opposite sides (outer side and inner side) of the at least one frame, such that the at least one frame is dimensioned and positioned to be attached to the margo supraorbitalis (interpreted as language of intended use; fully capable of being attached to the margo supraorbitalis, for example in the concavity of the margo supraorbitalis, and particularly since the frame is bendable to conform to any underlying or adjacent structure).
As to claim 21, Wellisz discloses the implant according to claim 19, wherein the at least one adaptation area is continuous and is free of frames inside of the outer edge, FIG. 1.
As to claim 22, Wellisz discloses the implant according to claim 19, wherein the at least one frame is dimensioned and arranged such that at least half of the outer edge is continuously not delimited by the at least one frame, FIG. 1.
As to claim 23, Wellisz discloses the implant according to claim 19, wherein the at least one adaptation area comprises a lattice structure (col. 1 / lines 54-56) dimensioned, such that it can be deformed by hand or with hand tools (col. 2 / lines 58-63).
As to claim 24, Wellisz discloses the implant according to claim 19, wherein the implant comprises a biocompatible material (col. 1 / lines 52-54).
As to claim 25, Wellisz discloses the implant according to claim 19, wherein the at least one adaptation area comprises connection areas (12) dimensioned to be cut by means of hand tools (interpreted as language of intended use; the connection areas are fully capable of being cut by hand tools since they are spaced apart from adjacent structures).
As to claim 27, Wellisz discloses the implant according to claim 19, wherein the at least one frame is dimensioned and positioned to be attached (to the bone via fastener holes 32).
As to claim 30, Wellisz discloses the implant according to claim 19, wherein the implant comprises at least one attachment tab (29-31) (col. 3 / lines 7-21), FIG. 1.
As to claim 31, Wellisz discloses the implant according to claim 30, wherein the at least one attachment tab is integrally connected to one of the at least one frame, FIG. 1.
As to claim 32, Wellisz discloses the implant according to one of claims 30, wherein the at least one attachment tab is adapted for attachment to the nasal bone (interpreted as language of intended use; fully capable of attachment to the nasal bone if positioned adjacently thereto since the attachment tabs and adaptation area are bendable to conform to the underlying bone structure), and wherein at least one attachment tab is dimensioned like the at least one frame (at least same dimension of thickness since the entire implant has a generally uniform thickness) and has a bendability that corresponds to (is at least similar to) the at least one frame (the frame and tab have similar widths so their bendabilities at least where these similar widths are measured would correspond).
As to claim 33, Wellisz discloses the implant according to claim 19, wherein the implant is adapted to cover defects or drill holes or to reconstruct bone defects or malformations at the sinus (interpreted as language of intended use; fully capable of any of these applications if positioned appropriately relative to the hole/defect and bended to conform to the surrounding bone).
As to claim 34, Wellisz discloses the implant according to claim 19, wherein the at least one adaptation area is formed integrally, FIG. 1.
As to claim 35, Wellisz discloses the implant according to claim 19, wherein the entire implant is formed integrally, FIG. 1.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Wellisz in view of U.S. Patent No. US 8,298,292 to Swords et al. (hereinafter, “Swords”).
Wellisz is silent as to wherein the implant has at least one side length in a range of 10-200 mm.
Swords teaches that an orbital implant may be 10 mm in length (col. 12 / line 66 – col. 13 / line 3).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide Wellisz’s implant with a length of 10 mm, since Swords teaches that an orbital implant may be 10 mm in length, and since discovering an optimum value of a result effective variable involves only routine skill in the art. This length would be referred to as a side length, since it can be measured along a side of the implant.
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 TRACY L KAMIKAWA whose telephone number is (571)270-7276. The examiner can normally be reached M-F 10:00-6:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong, can be reached at 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TRACY L KAMIKAWA/Examiner, Art Unit 3775
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