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 .
Election/Restrictions
Applicant’s election without traverse of species F, figs. 6-8, in the reply filed on 03 November 2025 is acknowledged.
Applicant contends, claims 28, 29, 46-52, 56-58 and 68-74 are generic and should all be examined. However, claims 42-44 and 64-66 recite “a/the plurality of first rings…..; and “a/the plurality of second rings,” wherein such limitations are drawn to non-elected species G (Figs. 9-10 show first and second rings 904, 905), thus claims 42-44 and 64-66 are not drawn to elected species F, which only has a plurality of first rings 604. Claims 56-58 depend from non-elected claim 53; therefore, claims 56-58 are included as being drawn to a non-elected species to which claim 53 is drawn to. Lastly, claim 73 recites “a bone plate,” “a first component,” “a second component,” “the first component being between the bone plate and the second component,” and “fasteners to fasten the bone plate to the second component.” Such limitations appear to be drawn to non-elected species G, figs. 9-10, which shows bone plate 902, first component 905, second component 904, with the first component between the bone plate and the second component, and fasteners 906 to fasten the bone plate to the second component. For such reasons, claims 42-44, 56-58, 64-66, 73 and 74 are further withdrawn as being drawn to non-elected species.
Claims 30-37, 42-44, 53-59, 64-66 and 73-74 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03 November 2025.
Claim Objections
Claim 51 is objected to because of the following informalities:
Claim 51, line 3: “is” should be changed to --being--.
Appropriate correction is required.
Applicant is advised that should claim 28 be found allowable, claim 51 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 38-41, 45, 60-63 and 67 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.
Claims 38 and 60 recite “each of the bone plate, the first component and the second component defines a plurality of openings.” However, looking to applicant’s elected species F, figs. 6-8, it appears only the bone plate (602) and the first component (604) defines the plurality of openings. Therefore, the claims will be interpreted as such. A further clarifying amendment is required.
Claims 38 and 60 recite “the kit further includes a plurality of fasteners to extend……through the plurality of openings.” It is unclear if the “plurality of fasteners” of line 11 are the same as or different than the “second component includes a plurality of fasteners” previously recited in line 4.” Looking the applicant’s elected species F, figs. 6-8, it appears the second component (606) corresponds to the plurality of fasteners. Therefore, the claims will be interpreted as both “plurality of fasteners” are the same. A further clarifying amendment is required.
Claims 39 and 61 recite “the plurality of openings correspond to a plurality of threaded openings.” However, previous claims 39 and 60 recite “each of the bone plate, the first component and the second component defines a plurality of openings.” Looking to applicant’s elected species F, figs. 6-8, it appears only openings (608) of the bone plate (602) are threaded. Therefore, the claims will be interpreted as such. A further clarifying amendment is required.
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(s) 28, 38, 39, 45, 47-51, 60, 61, 67, and 69-72 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gause et al., U.S. Patent 7,862,597 in view of Danoff et al., U.S. PG-Pub 2006/0190080.
Regarding claims 28 and 51, Gause et al. discloses a kit to form an orthopedic implant assembly, the kit/orthopedic implant assembly comprising: a bone plate (22) having an outer surface (46) to contact a fractured bone; a first component (152) including a material and having a first surface (178) that, when in the orthopedic implant assembly, is non-planar (in as much non-planar as applicant’s interior surface of component 604 in applicant’s elected species F, figs. 6-8); and a second component (150) have a second surface (162), the second surface being non-planar (in as much as applicant’s second component 606 in applicant’s elected species F, figs. 6-8), wherein, when in the orthopedic implant assembly, the first component is configured to be between the bone plate and the second component and the first surface conforms to and is adjacent to the second surface (Figs. 9-10).
Gause et al. does not disclose the material of the first component as being piezoelectric.
Danoff et al. discloses an orthopedic implant assembly having a first component (52) that is a piezoelectric material underneath the head portion of a second component (49) (Figs. 6A-6B) to stimulate bone growth (paragraph [0034])
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the material of the first component of Gause et al. to be a piezoelectric in view of Danoff et al. to permit stimulation of bone growth by the kit/orthopedic implant assembly once implanted onto a bone of a patient.
Regarding claims 38 and 60, as best understood, Gause et al. discloses wherein the first component (152) includes a plurality of rings (washer is a ring), and the first surface (178) corresponds to a concave-conical-frustum-shaped ring surfaces of respective ones of the plurality of rings; the second component (150) includes a plurality of fasteners, and the second surface (162) corresponds to a convex-conical-frustum-shaped bearing surfaces at an underside of heads (154) of respective ones of the plurality of fasteners, individual ones of the concave-conical-frustum-shaped ring surfaces conforming to and adjacent to respective corresponding ones of the convex-conical-frustum-shaped bearing surfaces of the plurality of fasteners; each of the bone plate (22) and the first component (152) defining a plurality of openings (90, 174) extending therethrough; and the plurality of fasteners of the second component extend, when in the orthopedic implant assembly, through the plurality of openings to attach the orthopedic implant assembly to a bone, respective ones of the plurality of rings to be, when in the orthopedic implant assembly, between respective ones of the plurality of fasteners on one hand, and the bone plate on another hand (Figs. 9-14).
Regarding claims 39 and 61, as best understood, Gause et al. discloses wherein the plurality of fasteners (150) include a plurality of screws; and the plurality of openings in the bone plate (22) correspond to a plurality of threaded openings (92), the plurality of screws to extend through and engage threads of corresponding ones of the plurality of threaded openings when in the orthopedic implant assembly (Figs. 9, 10 and 13).
Regarding claims 45 and 67, Gause et al. discloses wherein respective ones of the plurality of rings include convex-conical-frustum-shaped ring surfaces (170) opposite the concave-conical-frustum-shaped rings surfaces (178); and the bone plate (22) defines, at entry regions of respective one of the plurality of openings thereof (90), respective concave-conical-frustum-shaped bone plate surface that are to receive, when in the orthopedic implant assembly, corresponding ones of the convex-conical-frustum-shaped ring surfaces (Figs. 9-14).
Regarding claims 47 and 69, Gause et al. discloses wherein the material of the bone plate (22) is selected from the group consisting of an electrically conductive material, an electrically non-conductive material, and combinations thereof (Col. 4 lines 1-8), but does not explicitly disclose the material of the second component.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the material of the second component to be the same as that of the bone plate to permit biocompatibility within a patient.
Regarding claims 48, 49, 70 and 71, Gause et al. discloses wherein the bone plate (22), the first component (152) and the second component (150) are configured such that the bone plate and the second component are to cause a compressive force (152 is sandwiched between plate 22 and screw 150) and a shear force on the first component (surfaces of each component slide with one another where friction present between the surfaces as they slide past one another); and wherein at least one of the compressive force or the shear are to be distributed unevenly through the first component (applicant’s disclosure, paragraph [0067] of the specification, discloses the uneven application of force is due to when a patient walks or bends forward and subjects the implant to a simple compressive or shear load; therefore, Gause et al. would act in a similar manner) Figs. 9-12).
Regarding claims 50 and 72, the combination of Gause et al. in view of Danoff et al. discloses wherein the second component (150) has an outer surface (162), and wherein the first component (152) is configured to produce, for the orthopedic implant assembly, an electrical output corresponding to a load applied to the outer surface of the bone plate (22) and to the outer surface of the second component (see rejection of claims 28/51 above).
Claim(s) 29 and 52 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gause et al., U.S. Patent 7,862,597 in view of Danoff et al., U.S. PG-Pub 2006/0190080 as applied above, and further in view of Hawkes et al., U.S. Patent 7,766,947.
Regarding claims 29 and 52, Gause et al. discloses wherein the first surface (178) and the second surface (162) each include component surfaces that taper at a degree angle relative to a vertical axis (10-10), but does not disclose what the angle explicitly is.
Hawkes et al. discloses a kit having a first component (64) with a first surface (68) and a second component (70) with a second surface (72) that are angled, tapered surfaces (Fig. 5) wherein the angle may be any suitable taper angle such that locking between the two may be formed (Col. 7 lines 41-47).
It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the first and second surfaces of Gause et al. such that the surfaces have an orientation of 30 degrees to 60 degrees relative to the vertical axis further in view of Hawkes et al. to permit locking between engagement between the first and second components.
Claim(s) 40 and 62 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gause et al., U.S. Patent 7,862,597 in view of Danoff et al., U.S. PG-Pub 2006/0190080 as applied above, and further in view of Dacosta et al., U.S. PG-Pub 2016/0135858.
Regarding claims 40 and 62, Gause et al. in view of Danoff et al. discloses the invention essentially as claimed except for wherein the plurality of screws are lag screws.
Dacosta et al. discloses a kit of an orthopedic assembly where a lag screw is shown to be equivalent to other types of screws for crossing a joint or fracture (paragraph [0046]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the screws of Gause et al. to be lag screws further in view of Dacosta et al. as such are well-known equivalents for crossing a joint or fracture for fixation of a bone plate to bone.
Claim(s) 41 and 63 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gause et al., U.S. Patent 7,862,597 in view of Danoff et al., U.S. PG-Pub 2006/0190080 as applied above, and further in view of Silva et al., U.S. PG-Pub 2018/0140339.
Regarding claims 41 and 63, Gause et al. in view of Danoff et al. discloses the invention essentially as claimed except for wherein some of the plurality of screws have lengths that are different from lengths of other ones of the plurality of screws.
Silva et al. discloses a kit having screw of different lengths to provide appropriate fixation and repair of a bone injury (paragraph [0016]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the plurality of screws of Gause et al. to be different lengths further in view of Silva et al. to permit providing appropriate fixation and repair of a bone injury.
Claim(s) 46 and 68 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gause et al., U.S. Patent 7,862,597 in view of Danoff et al., U.S. PG-Pub 2006/0190080 as applied above, and further in view of Elvin et al., U.S. Patent 6,034,296.
Gause et al. in view of Danoff et al. discloses the invention essentially as claimed except for wherein the piezoelectric material includes at least one of polyvinylidene fluoride or polyvinylidene difluoride (PVDF).
Elvin et al. discloses piezoelectric material of polyvinylidene fluoride as being biocompatible with virtually no tissue reaction (Col. 6 lines 30-37).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the piezoelectric material of Gause et al. in view of Danoff et al. to be polyvinylidene fluoride further in view of Elvin et al. permit biocompatibility with virtually no tissue reaction once implant within a patient.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric Gibson whose telephone number is (571)270-5274. The examiner can normally be reached Monday-Thursday ~6:00 A.M. to 4:00 P.M. (CST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, 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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/ERIC S GIBSON/ Primary Examiner, Art Unit 3775