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 31 December 2025. Claims 1-4 and 6-12 are currently pending. Of these, claims 9-11 are withdrawn from further consideration as being drawn to a non-elected invention.
Specification
The amendment filed 08 March 2024 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows:
The incorporation by reference of International Patent Application No. PCT/EP2022/074820 and of Provisional Application No. 63/242,665 is ineffective as it was added on the date of entry into the national phase, which is after the filing date of the instant application. The filing date of this national stage application is the filing date of associated PCT, in this case 07 September 2022 (see MPEP 1893.03(b)). Therefore the specification amendment of 08 March 2024 to include the incorporation by reference is new matter, per MPEP 608.01(p).
Applicant is required to cancel the new matter in the reply to this Office Action.
Note: This issue can be remedied by removing the statement "the disclosure of which is incorporated herein by reference in its entirety" from paragraph 0001 of the specification.
Claim Objections
Claim 1 is objected to because of the following informalities:
In line 8, it appears that the phrase “connecting first portion to second portion” should read “connecting the first portion to the second portion.”
In lines 8-9, it appears that the phrase “such that first and second portion” should read “such that the first and second portions.”
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.
Claims 1-4, 6-8 and 12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the angled portion bridge being “substantially perpendicular” to the first side and the fourth side (see page 5, lines 21-25 of the current specification), does not reasonably provide enablement for the angled portion bridge being “perpendicular” to the first side and the fourth side (see amended claim 1). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims. Since claims 2-4, 6-8 and 12 are dependent upon claim 1, they contain the same issue.
Note: It appears that amending lines 9-10 of claim 1 to read “wherein the angled portion bridge is substantially perpendicular to the first side and the fourth side” would overcome this rejection. For examination purposes, claim 1 will be treated as such.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 6-8 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Bruecker et al. (U.S. Patent Application Publication 2008/0045960) in view of Wotton, III et al. (U.S. Patent 10,864,026).
Bruecker et al. disclose (as to part of claim 1) a plate (10) capable of adjusting an angle of a medial compartment of an ulna by adjusting torsion of the ulna (see Note below regarding effect of the preamble), wherein the plate comprises a first portion (17) and a second portion (19); the first portion including a first side (i.e. side of 17 defining 16), and a second side (i.e. side of 17 defining 14) spaced apart from and substantially parallel to the first side (spacing and substantially parallel configuration as best seen in Figure 2); the second portion including a third side (i.e. side of 19 defining 16), and a fourth side (i.e. side of 19 defining 14) spaced apart from and substantially parallel to the third side (spacing and substantially parallel configuration as best seen in Figure 2); an angled portion bridge (21) connecting the first portion to the second portion, such that the first and second portions are aligned in a long axis (12) of the plate, wherein the angled portion bridge is substantially perpendicular to the first side and the fourth side (substantially perpendicular orientation as best seen in Figure 3); an angle (θ) between the first side of the first portion and the third side of the second portion (see Figure 2); and a plurality of screw holes (holes as best seen in Figure 1) formed in the plate from the first side to the second side in the first portion and from the third side to the fourth side of the second portion to attach the plate to a bone, wherein (as to claim 2) the plate is capable of being attached to an ulna after cutting the ulna near its distal end (see Note below regarding functional language given that claim 2 does not add/require additional structure), wherein (as to claim 3) the first portion is capable of being attached to a proximal part of a cut ulna and the second portion is capable of being attached to a distal part of the cut ulna (see Note below regarding functional language given that claim 3 does not add/require additional structure), wherein (as to claim 6) the plate is capable of being attached to a lateral-caudal side of the ulna (see Note below regarding functional language given that claim 6 does not add/require additional structure), wherein (as to claim 7) the plate is capable of treating of an arthritic disease of an elbow (see Note below regarding functional language given that claim 7 does not add/require additional structure), wherein (as to claim 8) the plate is capable of adjusting the angle of the medial compartment of an ulna in a dog (see Note below regarding functional language given that claim 8 does not add/require additional structure), and wherein (as to claim 12) the plate is capable of treating of a dysplasia caused by a fragmented coronoid process (PCP) or medial compartment disease (MCD) (see Note below regarding functional language given that claim 12 does not add/require additional structure) (see Figures 1-5, and paragraphs 0026-0043).
Bruecker et al. disclose wherein the first portion and the second portion are non-parallel to each other (see paragraph 0026); however, fail to explicitly disclose wherein (as to part of claim 1) the angle is between about 5 degrees and about 60 degrees, and wherein (as to claim 4) the angle is selected based on an error in alignment determined by measuring the torsion when a forelimb is held in an extended position and a wrist is hyperextended.
However, Bruecker et al. set forth that the angle to which the portions are non-parallel to each other is a result effective variable, wherein the angle depends upon the particular bone and particular subject/patient to which the plate is being applied (see paragraph 0012).
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 Bruecker et al. with wherein the angle is between about 5 degrees and about 60 degrees, and wherein the angle is selected based on an error in alignment determined by measuring the torsion when a forelimb is held in an extended position and a wrist is hyperextended, for the purpose of providing an angle best suited to the particular subject/patient to which the plate is being applied to yield predictable results, 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 (see In re Aller, 105 USPQ 233).
Bruecker et al. disclose the claimed invention except for wherein (as to the remainder of claim 1) the second side and the fourth side comprise a plurality of concave areas, each concave area disposed between adjacent screw holes and capable of minimizing contact of the second side and the fourth side with the bone.
Wotton, III et al. teach the use of a plate (40) comprising a side (70) comprising a plurality of concave areas (83a-83f), each concave area disposed between adjacent screw holes (e.g. 48a-48c, disposition as best seen in Figure 5) (see Figure 5, and column 7, lines 24-54).
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 Bruecker et al. with wherein the second side and the fourth side comprise a plurality of concave areas, each concave area disposed between adjacent screw holes in view of Wotton, III et al. in order to provide a well-known, obvious means for reducing the amount of contact that the second and fourth sides of the plate have with bone when the plate is fixed in place and to promote potential/desired bending of the plate at the concave areas to yield predictable results.
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)). Regarding the effect of the preamble, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. Furthermore, a preamble generally is not limiting when the claim body describes a structurally complete invention such that deletion of the preamble phrase does not affect the structure or steps of the claimed invention (see MPEP 2111.02(II)).
Response to Arguments
Applicant’s arguments with respect to claims 1-4, 6-8 and 12 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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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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/LARRY E WAGGLE, JR/Primary Examiner, Art Unit 3775