DETAILED ACTION
This office action is responsive to the amendment filed June 24, 2025. By that amendment, claims 1-4 were amended; claims 11-21 were newly presented; and claim 8 was canceled. Claims 1-7 and 9-21 stand pending.
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 with respect to the rejection of claim(s) 1-10 under 35 USC 102(a)(1) in view of Vicatos et al. (US 2014/0324046 A1) 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. The newly presented rejection is necessitated by the amendments to the claims of June 24, 2025.
Claim Rejections - 35 USC § 112
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.
Claims 1-7 and 9-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, 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.
Claim 1 uses the term “compression fixer”. It is unclear what is meant by this term. The instant specification has been studied, and the term is not clarified. The figures are studied, but the compression fixer is identified at instant [0050] as a not-shown component. What is meant by the term ‘compression fixer’ (or not) must be clarified. The metes and bounds of the term are not definite as presently presented.
Depending on response to this rejection, a rejection under 35 USC 112(a) may be required; and additionally a drawing objection if it becomes clear that the compression fixer is required by the claim but not shown in the drawings.
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.
Claim(s) 1-4, 9, 10, 12-18, 20 and 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Reisberg (US 8,795,342 B2).
Regarding claim 1, Reisberg teaches a deformable metal plate 1 (bendable at 6, col. 7, lines 45-52) for bone fracture treatment, the deformable metal plate comprising:
a metal plate body 2 (metal as at col. 5, lines 58-62) having body screw insertion holes 14a/b at predetermined intervals – there is no reason these holes cannot receive properly sized and shaped screws therein – holes 14a/b labeled in fig. 1; seen in fig. 4, unlabeled – a screw can be passed through 14a/b at least when 14a/b is aligned with holes 13a or 13b (seen in fig. 2);
a plurality of uneven portions 12 disposed on both sides of the metal plate body 2 along a longitudinal direction of the metal plate body 2 at predetermined intervals (see fig. 4) ; and
a variable metal plate 1 (metal as at col. 5, lines 58-62) configured to be slid along and coupled to a part of the plurality of uneven portions 12 (see fig. 4; sliding as described at col. 8, lines 9-16; 7 is referred to as a ‘sliding surface’ at col. 8, line 39), the variable metal plate 1 having:
an uneven coupling portion 8 with a C-shaped cross-section (seen in fig. 2), the uneven coupling portion 8 surrounding the metal plate body 2 when assembled as in fig. 4, wherein a first inner side 9a and a second inner side 9b of the uneven coupling portion 8 being opposite to each other are configured to be coupled to the part of the plurality of uneven portions 12, and
an extension arm 3a-6 extending from the uneven coupling portion 8 (see fig. 2), wherein a variable screw insertion hole 13a/b is defined at an end of the extension arm (these holes formed in the proximal end of the arm – there is no reason a properly sized/shaped screw cannot be variably inserted into these holes),
wherein when the uneven coupling portion 8 is coupled to the part of the plurality of uneven portions 12, the uneven coupling portion 8 and the part of the plurality of uneven portions 12 are configured to define a predetermined gap therebetween (inherently; a gap is present, or not, based on the structures of the two portions, this amount of gap being predetermined by design and machining process), and the uneven coupling portion 8 is compressed by a compression fixer (pliers – col. 3, lines 52-56) and is coupled to the part of the plurality of uneven portions 12, and
wherein when the uneven coupling portion 8 is coupled to the metal plate body 2, the extension arm 3a-6 has a predetermined angle with the longitudinal direction of the metal plate body 2 as can be seen clearly in fig. 1.
Regarding claim 2, when the uneven coupling portion 8 is coupled to the metal plate body 2, the extension arm 3a-6 is in a parallel direction with the longitudinal direction of the metal plate body 2 (in at least region 4/6), and the variable screw insertion hole 13a/b is positioned along an extended line of a length of the metal plate body 2.
Regarding claim 3, when the uneven coupling portion 8 is coupled to the metal plate body 2, the extension arm portions 3a-c are normal to the longitudinal direction of the metal plate body 2 (when choosing a 0 degree angle a version of variable metal plate 1 – see fig. 5, top version).
Regarding claim 4, when the uneven coupling portion is coupled to the metal plate body 2, the extension arm has an angle greater than 0 degrees and less than 90 degrees (choosing the bottom two embodiments of fig. 5) with the longitudinal direction of the metal plate body 2.
Regarding claim 9, a plurality of variable metal plates 1/1’ are attached to the metal plate body 2 as in fig. 1.
Regarding claim 10, each extension arm of the plurality of the variable metal plates 1/1’ has a different angle with the longitudinal direction of the metal plate body 2 from one another – the kit is provided with various shapes of 1/1’ (col. 6, lines 10-20), and the surgeon can choose the appropriate plates 1/1’ in the system (col. 9, lines 42-47).
Regarding claims 12-16, and 20, the plurality of uneven portions 12 comprises a plurality of concave portions and a plurality of uneven protrusions (seen most clearly in fig. 4, 12 includes ripples with concave portions and protrusions which are uneven in that the undulate along the length of 2). Each of the plurality of concave portions is defined between two adjacent uneven protrusions as seen in fig. 4. Each of the plurality of uneven protrusions of 12 has a protrusion height defined from a peak thereof to a bottom of the plurality of protrusions; each of plurality of concave portions has a recessed area recessed toward the metal plate body; a concave height is a height difference between the peak of the plurality of uneven protrusions and bottom of the recessed area; and the concave height is greater than the protrusion height: see marked up figure – the axis differentiating the two sections can be placed anywhere, as presently claimed. The concave portions have curved bottoms, which are also considered to be essentially V-shaped. As seen in fig. 4, the insertion holes 14a/b are offset from the plurality of uneven protrusions.
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Regarding claims 17 and 18, since no structural distinction is provided between concave portions, there is no reason that only certain ones of the portions cannot be designated as the concave portions, while the other dips considered portions of the protrusions. This is a mentally designated assignment of names to the portions. Making such an interpretation permits consideration of two uneven protrusions being defined between two adjacent mentally designated concave portions, or at least three uneven protrusions defined between two adjacent mentally designated concave portions.
Regarding claim 21, portions between protrusions of portion 8 (seen in detail in fig. 3 will be considered cutout grooves. These portions will be for coupling to part of the uneven protrusions 12.
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.
Claim(s) 5-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reisberg in view of Vicatos et al. (US 2014/0324046 A1) and Ellis et al.(US 2005/0085819 A1).
Regarding claims 5-7, for rejecting this claim, the extension arm of the variable metal plate 1 will now only be considered to be portions 4, 5, and 6. One of portions 3a-c will be considered an auxiliary metal plate body attached to the end of the extension arm 4-6. and having a plurality of auxiliary screw insertion holes. The auxiliary plate 3a-c is of a different length than the metal plate body 2 and has a predetermined angle relative to the extension arm 4-6.
Reisberg fails to teach the auxiliary body including a plurality of auxiliary screw insertion holes.
Vicatos teaches a plate design including a metal plate body 2 coupled to a variable metal plate 4. The variable metal plate 4 includes an extension arm (portion with no holes therein) with auxiliary metal plate bodies 22 attached thereto. The bodies 22 include auxiliary screw insertion holes (capable of receiving appropriately sized/shaped screws therethrough).
It would have been obvious to one with ordinary skill in the art at the time of the invention to add auxiliary screw holes as arranged in Vicatos to the auxiliary plate 3a-c of Reisberg, in view of the Vicatos teaching. One would have done so in order to augment retention of the plate to the bone.
Reisberg teaches that use of screws is the “usual” method of performing a rib operation. (col. 2, lines 10-14). While further teachings of Reisberg arguably teach away from use of screws, Reisberg has admitted that this is the normal way of attaching plates to ribs.
Ellis further demonstrates a rib plate design in which screws 44 are driven through holes in a rib plate. Therefore, it would have been obvious to one with ordinary skill at the time of the invention to add screws and screw holes to the combination plate. One would have done so in order to secure the plate to the bone pieces (Ellis [0030]).
Claim(s) 11 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reisberg in view of Ellis.
Regarding claims 11 and 19, Reisberg teaches the limitations of claim 1 above. As discussed, above, Reisberg teaches these holes becoming vertically aligned during use. Further, Reisberg has taught that use of screws in rib plates is the “usual” method.
However, Reisberg fails to teach the body screw insertion holes 14a/b and the variable screw insertion hole 13a/b have a shape of an elongated hole extending along a longitudinal direction of the metal plate body.
Ellis teaches a two-plate rib plate design as at figs. 1-3. The first and second plates include screw holes 46/66 which become aligned during attachment of the plates together and to the bone. The screw holes 46/66 are demonstrating being elongated holes. Ellis further teaches screw holes at various locations along a length of the plate, seen by comparing figs. 14 and 15.
It would have been obvious to one with ordinary skill in the art at the time of the invention to form the Reisberg plates with elongated holes 13a/b and 14a/b in order to permit additional movement of the plates relative to one another while fixation equipment is passed therethrough. One would have done so in order to permit use of the Reisberg plate in a larger range of sizes/shapes of bone. It also would have been obvious to provide additional holes at any locations on the plate to permit coupling at additional locations on the plate.
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 David Bates whose telephone number is (571)270-7034. The examiner can normally be reached Monday through Friday, 10AM-6PM
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/DAVID W BATES/Primary Examiner, Art Unit 3799