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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 27 April 2026 has been entered.
Response to Amendment
This Office Action is responsive to the amendment filed on 27 April 2026. As directed by the amendment: claim 7 has been amended, claims 1-6, 8, and 9 are cancelled, and claim 12 stands withdrawn. Claims 7 and 10-14 currently stand pending in the application.
Response to Arguments
Applicant’s arguments with respect to the rejections under 35 U.S.C. 103 have been fully considered but they are not persuasive.
Applicant contends that the drawings in Lewis et al. (US 2009/0248087) cannot be relied upon to disclose specific measurement. Examiner respectfully submits that even if Lewis’ figures are not to scale, the shoulder 42 is disclosed as undercut to form a flange 44 (par. [0012]), which is shown to protrude outwardly from the sidewall 46 and smoothly connect thereto via the undercut. Because the claimed range is so small, about 0.2 to about 0.4 degrees, at one point in the transition from 46 to 44, the total angle of the screw head would achieve this increase in angle range, even if the drawings are not to scale, since if Lewis’ screw head were to not meet this claimed angle range, the transition from 46 to 44, using an undercut, would require an angle increase of less than 0.2 degrees. Even allowing for differences in scale to the figures of Lewis, such a very small angle increase would be highly unlikely. Note that the rejection is not inferring that the total angle of the screw head is only ever about 0.2 to about 0.4 degrees larger than the total angle of the conical hole; the total angle of the screw head continues on to be greater than this range to reach 44, but at some point in the transition, passes through the claimed range. Examiner notes that assuming arguendo, the claimed angle range was also taught by Wilkin (US 2014/0251628).
As to Wilkin (US 2014/0251628), Applicant contends that Wilkin is not analogous prior art. Examiner respectfully submits that Wilkin is reasonably pertinent to the problem faced by the inventor, since Wilkin teaches a manufacturing tolerance of a conical hole in a Morse taper connection. Surgical devices such as screws and plates are structural components that must be manufactured. As to the present application, the screw head and bead have interacting conical shapes which would lead an inventor’s attention to a Morse taper. Since Wilkin teaches a manufacturing tolerance of a conical hole in a Morse taper connection, this would be applicable to the manufacturing of any hole used in a Morse taper connection, including that of the instant application. A skilled artisan, seeking to manufacture or design the connection between two nested tapered components, would look to other such connections to determine a manufacturing or machine tolerance that offers a desirable cost/benefit balance, or that is commonly used. Applicant contends that there is no suggestion in Wilkin that the wedged cone disclosed by Wilkin functions in such a way as to position sleeves at a particular angle relative to one another. Examiner respectfully submits that the claimed difference in total angle of the conical screw head and the conical hole in the spherical bead is related to how the conical screw head seats in the bead in a reversible locking way. The instant specification itself refers to this as a Morse taper (par. [0002] of the publication). This interaction, and the angle difference between screw/bead, does not affect the angle of the sleeve (assumed to mean the bead) in the plate. The angle of the sleeve/bead in the plate is affected by the spherical external shape of the bead. Positioning the screw head and bead at a particular angle relative to one another is not achieved by the Morse taper, other than the Morse taper (and the claimed angle difference) allowing concentric seating of the screw head in the bead, and therefore it is unclear why Wilkin’s invention would need to position sleeves at a particular angle relative to one another when it is relied upon as a teaching of machine tolerance of a Morse taper connection, such Morse taper connection also disclosed in the instant invention.
As to the modification in view of Zahrly (US 9,125,699), Applicant contends that the Office has not provided any technical reasoning or evidence that supports its conclusion that Zahrly’s bumps would function in the same way as Lewis’ threads. Examiner respectfully submits that Lewis discloses that the locking ring is deformable relative to the opening in which it seats (par. [0005]), which results in the locking of the screw in place, i.e. the material/deformability of the locking ring is more important to the deformation and locking than the shape of the protrusions in the receiving hole. Bumps are protrusions, and providing bumps on Lewis’ plate hole would deform a deformable locking ring placed therein, based on the material/deformability of the locking ring. In other words, any protrusion would deform the deformable material simply because it is a deformable material. Lewis also discloses “high friction deformation means, such as a series of internal threads” (par. [0005]). The phrase “such as” means that threads are not the only type of high friction deformation means contemplated by Lewis. Zahrly teaches that bumps can be used instead of threads for such grasping and securing of a polyaxial fastener inserted therein. The bumps, or protrusions as above, would deform the deformable locking ring as disclosed by Lewis. A threaded locking screw is also fully capable of use in the receiving hole with the bumps as taught by Zahrly, with the threads on the screw aligning with rows of the bumps.
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 10, 11, and 14 are 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 10, the limitation “a self-locking angle” renders the claim indefinite, because it is unclear if this refers to the total angle of the conical hole in the spherical bead, previously recited in claim 7, or to a different self-locking angle of the conical hole in the spherical bead. For examination purposes, the self-locking angle will be interpreted as the previously recited total angle. Amendment is required for consistency and proper antecedence.
As to claim 11, the limitation “an angle of the conical hole in the spherical bead” renders the claim indefinite, because it is unclear if this refers to the total angle of the conical hole in the spherical bead, previously recited in claim 7, or to a different angle of the conical hole in the spherical bead. For examination purposes, the angle will be interpreted as the previously recited total angle. Amendment is required for consistency and proper antecedence. Any amendments to claim 11 would require consistent amendment to dependent claim 14, which also recites “the angle of the conical hole in the spherical bead” which is consistent with claim 11 but not with claim 7.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 11, 13, and 14 are rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 11 and 14 fail to include all the limitations of the claim upon which they depend, because they recite “The implant construction” whereas claim 7 recites “An implant construct”.
Claim 13 is dependent upon cancelled claim 9.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 7, 10, 11, 13, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. US 2009/0248087 to Lewis et al. (hereinafter, “Lewis”), in view of U.S. Patent No. US 9,125,699 to Zahrly et al. (hereinafter, “Zahrly”), U.S. Patent No. US 8,968,368 to Tepic, and U.S. Patent Application Publication No. US 2014/0251628 to Wilkin et al. (hereinafter, “Wilkin”).
As to claim 7, Lewis discloses an implant construct, FIGS. 1-4, comprising: a bone locking plate (14), a bone locking screw (32), and a spherical bead (24) (par. [0005]), FIGS. 1-2, wherein the spherical bead includes a conical hole (26) and is to be interposed between a conical head of the bone locking screw and a receiving hole (12) in the bone locking plate (par. [0012]), FIG. 1, wherein the receiving hole in the bone locking plate is conical, FIG. 1, wherein the bone locking plate has an upper surface (16) and a lower surface (18), and wherein a total angle of the conical head of the bone locking screw is larger than a total angle of the conical hole in the spherical bead by about 0.2 to about 0.4 degrees (the total angle taken immediately proximal to 46, where the screw head taper angle begins a gradual increase to the greater taper angle at 44; since the increase is gradual, at one point the total angle of the screw head would be larger than the angle of the hole/portion 46 by about 0.2 to about 0.4 degrees).
As to claim 10, Lewis discloses the implant construct of claim 7, wherein the conical hole (26) in the spherical bead is tapered with a self-locking angle (par. [0012]; the hole 26 is complementary to the taper angle of the screw head at 46 as shown in FIG. 1).
As to claim 11, Lewis discloses the implant construction of claim 7, wherein an angle of the conical hole in the spherical bead is between about 2.7 degrees and about 8 degrees (about 6 degrees as complementary to the screw head, par. [0012]).
As to claim 13, Lewis discloses the implant construct of claim 9, wherein the total angle of the conical head of the bone locking screw is larger than the total angle of the conical hole in the spherical bead by about 0.3 degrees (the total angle taken immediately proximal to 46, where the screw head taper angle begins a gradual increase to the greater taper angle at 44; since the increase is gradual, at one point the total angle of the screw head would be larger than the angle of the hole/portion 46 by about 0.3 degrees).
Lewis is silent as to the receiving hole in the bone locking plate is not threaded.
Zahrly teaches that a receiving hole in a bone locking plate can be not threaded but rather can comprise bumps (68) that extend inwardly from the inner surface of the receiving hole for grasping and securing a polyaxial fastener inserted therein (col. 8 / lines 1-9), FIG. 22.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Lewis’ bone locking plate receiving hole to have bumps instead of internal threads, since Zahrly teaches that bumps can be used in place of threads for grasping and securing a polyaxial fastener inserted therein, and since the simple substitution of one known element for another (type of grasping protrusions) to obtain predictable results (grasping and securing of a fastener) is within the ordinary skill in the art.
Lewis is silent as to wherein the receiving hole comprises longitudinally oriented cylindrical undercuts on the lower surface.
Tepic teaches a bone plate (100) and a bone locking screw (30; at least locks into the bone by threading), the bone screw having a spherical head (31) that is received in a conical receiving hole (at 11) in the bone plate that is not threaded (col. 6 / lines 11-15), FIG. 8, wherein the bone locking plate has an upper surface and a lower surface, and wherein the receiving hole comprises longitudinally oriented cylindrical undercuts (13) on the lower surface (col. 6 / lines 18-23), FIG. 5, that allow for angulation of the screw.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include in Lewis’ receiving hole, longitudinally oriented cylindrical undercuts on the lower surface of the bone plate to allow the screw to angulate to a greater angle along the longitudinal axis of the plate should self-compression of a fracture by the screw insertion be desired, as taught by Tepic. This would broaden the applicability of the plate to various bone morphologies.
Assuming arguendo, as to claims 7 and 13, Lewis discloses a total angle of the conical head of the bone locking screw is about 6 degrees (par. [0012]) and a total angle of the conical hole in the spherical bead is complementary to the taper angle of the conical screw head at 46 as shown in FIG. 1.
Lewis is silent as to a total angle of the conical head of the bone locking screw is larger than a total angle of the conical hole in the spherical bead by about 0.2 to about 0.4 degrees (claim 7); the total angle of the conical head of the bone locking screw is larger than the total angle of the conical hole in the spherical bead by about 0.3 degrees (claim 13); and wherein the angle of the conical hole in the spherical bead is about 5.7 degrees, corresponding to a taper of the conical hole in the spherical bead of 1:10 (claim 14).
Wilkin teaches that a manufacturing tolerance of a conical hole in a Morse taper connection is +/- 0.5 degrees (par. [0026]).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to allow a manufacturing or machine tolerance of +/- 0.5 degrees in the conical hole of the spherical bead, since this may be the limits of accuracy depending on the manufacturing machinery and material of the bead, and is a cost/benefit balance since improving the tolerance or machine accuracy would lead to an increase of manufacturing cost. Then, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention that the angle of the conical hole in the spherical bead is about 0.3 degrees less (which also meets the limitation of about 0.2 to about 0.4 degrees) than the total angle of the conical head of the bone locking screw, which would be about 5.7 degrees (6 – 0.3 = 5.7 degrees) since discovering an optimum value of a result effective variable involves only routine skill in the art, and Wilkin teaches that due to manufacturing tolerance, an angle may be up to 0.5 degrees less. As applied to Lewis, where the conical hole of the bead is complementary to the conical head of the screw and thus has a taper of about 6 degrees, up to 0.5 degrees less would include “about 0.3 degrees” (which also meets the limitation of about 0.2 to about 0.4 degrees) less or about 5.7 degrees. Because the angle of the conical hole in the spherical bead would be about 5.7 degrees, this corresponds to a taper of the conical hole in the spherical bead of 1:10, at least as much as the instant invention.
Conclusion
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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/TRACY L KAMIKAWA/Examiner, Art Unit 3775
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