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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 July 2, 2026 has been entered.
Status of the Claims
This Office Action is responsive to the amendment filed July 2, 2026. As directed by the amendment: Claims 1 and 8 have been amended. Claims 1-20 are presently pending in this application.
Examiner’s Note
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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, 5-7, and 11-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Erfinder wird später genannt werden (DE 102010041165 A1).
Regarding claim 1, Erfinder wird später genannt werden discloses a bi-directional drill point screw (figures 1-3) capable of drilling into bone comprising a shank (1) including a central longitudinal axis (figures 1-3), a proximal end (see figures below) and a distal end (see figures below), at least one helical thread (3) extending around and along a portion of an outer surface of the shank (1) (figures 1-3), the at least one helical thread (3) adapted for (i.e. capable of) interlocking cooperation with a bone (considered functional), the proximal end of the shank (1) includes a bi-directional drill point (6) (figures 1-3), the bi-directional drill point (6) having at least two web components (see figures below) separated by open flutes (see figures below), each web component (see figures below) including a cutting face (see figures below) at a most proximal end of the shank (see figures below), each cutting face including at least one cutting edge (see figures below) arranged to rotate around the central longitudinal axis (figures 1-3), wherein at least one cutting edge of one of the web components (see figures below) faces another at least one cutting edge of another of the web components (see figures below) such that there is a cutting edge on each side of the open flute (see figures below), wherein at least one cutting edge (see figures below) cuts when the bi-directional drill point bone screw is rotated in a clockwise direction (considered functional), and at least one cutting edge (see figures below) cuts when the bi-directional drill point bone screw is rotated in a counter-clockwise direction (figure 3), wherein rotary oscillation of the bi-directional drill point bone screw (figures 1-3) about the longitudinal axis of the shank forms a predetermined diameter aperture in a bone (considered functional).
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Regarding claim 5, Erfinder wird später genannt werden discloses wherein the bi-directional drill point (6) includes at least one additional web component (see figures above) separated by open flutes (see figures above), each web component including a cutting face at a most proximal end of the shank (see figures above), each cutting face including at least one cutting edge (see figures above) arranged to rotate around the central longitudinal axis (figures 1-3), wherein at least one cutting edge (see figures above) is arranged to (i.e. capable of) cut when the bidirectional drill point bone screw is rotated in a clockwise direction (considered functional) and at least one cutting edge (see figures above) is arranged to (i.e. capable of) cut when the bi-directional drill point bone screw is rotated in a counter-clockwise direction (considered functional).
Regarding claim 6, Erfinder wird später genannt werden discloses wherein the bi-directional drill point (6) includes at least two additional web components (see figures above) separated by open flutes (see figures above), each web component including a cutting face (see figures above) at a most proximal end of the shank (1), each cutting face including at least one cutting edge (see figures above) arranged to (i.e. capable of) rotate around the central longitudinal axis (figures 1-3), wherein at least two cutting edges (see figures above) are arranged to (i.e. capable of) cut when the bidirectional drill point bone screw is rotated in a clockwise direction (considered functional) and at least two cutting edges (see figures above) are arranged to (i.e. capable of) cut when the bi-directional drill point bone screw is rotated in a counter-clockwise direction (considered functional).
Regarding claim 7, Erfinder wird später genannt werden discloses wherein each cutting face includes at least two cutting edges (see figures above) arranged to rotate around the central longitudinal axis (figures 1-3), wherein at least one cutting edge of the at least two cutting edges on each cutting face (see figures above) is arranged to (i.e. capable of) cut when the bi-directional drill point bone screw is rotated in a clockwise direction (considered functional) and at least one other cutting edge of the at least two cutting edges on each cutting face (see figures above) is arranged to (i.e. capable of) cut when the bi-directional drill point bone screw is rotated in a counter-clockwise direction (considered functional).
Regarding claim 11, Erfinder wird später genannt werden discloses wherein each cutting face is a planar surface (figures 1-3).
Regarding claim 12, Erfinder wird später genannt werden discloses wherein each cutting face (see figures above) is arranged at an angle (figures 1-3) with respect to the longitudinal axis to create a point angle (figures 1-3), the point angle reducing longitudinal pressure required to start an aperture (considered functional).
Regarding claim 13, Erfinder wird später genannt werden discloses wherein the flutes (see figures above) are sized and shaped to (i.e. capable of) channel bone fragments and shavings away from the proximal end as the bi-directional drill point bone screw is oscillated (considered functional).
Regarding claim 14, Erfinder wird später genannt werden discloses wherein the at least one helical thread (3) is adapted to (i.e. capable of) cut threads in the aperture as the bidirectional drill point bone screw is rotated into the aperture (considered functional).
Regarding claim 15, Erfinder wird später genannt werden discloses wherein the at least one helical thread (3) is adapted to (i.e. capable of) compression form threads in the aperture as the bi-directional drill point bone screw is rotated into the aperture (considered functional).
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) 2-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Erfinder wird später genannt werden (DE 102010041165 A1).
Regarding claim 2, Erfinder wird später genannt werden’s screw discloses all the features/elements as claimed but lacks wherein the at least one cutting edge includes a face rake, the face rake arranged perpendicularly with respect to the cutting face extending along a respective web component.
However, Erfinder wird später genannt werden teaches in an alternative embodiment, at least one cutting edge (5) includes a face rake (figures 4-6), the face rake (figures 4-6) arranged perpendicularly with respect to the cutting face (5) extending along a respective web component (figures 4-6).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Erfinder wird später genannt werden’s screw with wherein the at least one cutting edge includes a face rake, the face rake arranged perpendicularly with respect to the cutting face extending along a respective web component as taught by Erfinder wird später genannt werden, since such a modification would change the amount of force to cut material.
Regarding claims 3, 4, Erfinder wird später genannt werden’s screw discloses all the features/elements as claimed but lacks a detailed description on wherein the at least one cutting edge includes a face rake, the face rake arranged to be at an angle of less than ninety degrees with respect to the cutting face extending along a respective web component, or wherein the at least one cutting edge includes a face rake, the face rake arranged to be at an angle of more than ninety degrees with respect to the cutting face extending along a respective web component.
However, the prior art discovering optimum or workable ranges involves routine experimentation in the art.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Erfinder wird später genannt werden’s screw with wherein the at least one cutting edge includes a face rake, the face rake arranged to be at an angle of less than ninety degrees with respect to the cutting face extending along a respective web component, or wherein the at least one cutting edge includes a face rake, the face rake arranged to be at an angle of more than ninety degrees with respect to the cutting face extending along a respective web component, since such a modification is considered optimization of the size of the prior art, wherein a change in an angle would change the amount of force needed to cut material.
Claim(s) 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Erfinder wird später genannt werden (DE 102010041165 A1) in view of Bono et al. (US 2019/0290290), herein referred to as Bono.
Regarding claim 8, Erfinder wird später genannt werden’s screw discloses all the features/elements as claimed including a web (see figures above), each web (see figures above) terminating at an outer periphery with a land (see figures above), the land (see figures above) constructed and arranged to control the diameter of the aperture created by the bi-directional drill point bone screw but lacks the each web component comprises a radiused root.
However, Bono teaches a web component (34) comprises a radiused root (figure 11 and claim 7).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify each web component of Erfinder wird später genannt werden’s with a radiused root as taught by Bono, since such a modification would provide an alternative flute shape.
Regarding claim 9, the modified Erfinder wird später genannt werden’s screw has wherein the land (see figures above) is constructed and arranged to (i.e. capable of) burnish a bone surface as the aperture is sized (considered functional).
Regarding claim 10, the modified Erfinder wird später genannt werden’s screw has wherein the land (see figures above) is constructed and arranged to (i.e. capable of) compress a bone surface as the aperture is sized (considered functional).
Claim(s) 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Erfinder wird später genannt werden (DE 102010041165 A1) in view of DiVincenzo et al. (US 2018/0368898), herein referred to as DiVincenzo.
Regarding claim 16, Erfinder wird später genannt werden’s screw discloses all the features/elements as claimed but lacks wherein the distal end of the shank includes a tool socket for cooperation with a driving tool for rotation and/or oscillation of the shank.
However, DiVincenzo teaches a distal end of a shank (102) includes a tool socket (110) (figure 8) for cooperation with a driving tool (¶30, ¶31) for rotation and/or oscillation of the shank (¶30, ¶31).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide Erfinder wird später genannt werden’s screw with wherein the distal end of the shank includes a tool socket for cooperation with a driving tool as taught by DiVincenzo, since such a modification would provide a placement for a driving tool to drive the screw into material (¶30, ¶31).
Regarding claims 17, 18, Erfinder wird später genannt werden’s screw discloses all the features/elements as claimed but lacks wherein the distal end of the shank includes a portion of a spherical ball, the portion of the spherical ball formed integral with the shank, including a polyaxial connector assembly, the polyaxial connector assembly including a socket for receiving the portion of a spherical ball therein, the portion of the spherical ball and the polyaxial connector assembly cooperating to allow the connector longitudinal axis and the shank to be positioned at angles relative to one another.
However, DiVincenzo teaches a distal end of a shank (figure 8) includes a portion of a spherical ball (e.g. polyaxial, ¶46), the portion of the spherical ball formed integral with the shank (¶46 and figure 8), including a polyaxial connector assembly (400), the polyaxial connector assembly (400) including a socket (¶45) for receiving the portion of a spherical ball (¶45) therein, the portion of the spherical ball (¶45) and the polyaxial connector assembly (400) cooperating to allow the connector longitudinal axis (figure 8) and the shank (figure 8) to be positioned at angles relative to one another (¶45, ¶46).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Erfinder wird später genannt werden’s screw with wherein the distal end of the shank includes a portion of a spherical ball, the portion of the spherical ball formed integral with the shank, including a polyaxial connector assembly, the polyaxial connector assembly including a socket for receiving the portion of a spherical ball therein, the portion of the spherical ball and the polyaxial connector assembly cooperating to allow the connector longitudinal axis and the shank to be positioned at angles relative to one another as taught by DiVincenzo, since such a modification would provide an alternative screw having polyaxial movements.
Regarding claim 19, the modified Erfinder wird später genannt werden’s screw has wherein the polyaxial connector assembly (400 of DiVincenzo) is constructed and arranged to (i.e. capable of) cooperate with a rod member for securing a first bi-directional drill point bone screw to a second bi-directional drill point bone screw (considered functional).
Regarding claim 20, the modified Erfinder wird später genannt werden’s screw has wherein the polyaxial connector assembly (400 of DiVincenzo) is constructed and arranged to (i.e. capable of) cooperate with a plate member for securing a first bi-directional drill point bone screw to a second bi-directional drill point bone screw (considered functional).
Response to Arguments
Applicant’s arguments on pages 7-8, under 35 U.S.C. 103, of the Remarks with respect to the reference Bales have been considered but are moot because the new ground of rejection does not rely on the reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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/SI MING KU/Primary Examiner, Art Unit 3775
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