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 .
Status of the Claims
This Office Action is responsive to the amendment filed December 16, 2025. As directed by the amendment: Claims 1-20 have been amended and 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 11-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bales (US 2016/0120583).
Regarding claim 1, Bales discloses a bi-directional drill point bone screw (100) (figures 1-5) comprising a shank (106) including a central longitudinal axis (102), a proximal end (112) and a distal end (120) (figure 1), at least one helical thread (116) extending around and along a portion of an outer surface (114) of the shank (106), the at least one helical thread (116) adapted for (i.e. capable of) interlocking cooperation with a bone (¶5), the proximal end (112) of the shank (106) includes a bi-directional drill point (104), the bidirectional drill point (104) having at least two web components (elements 264) separated by open flutes (elements 250), each web component (elements 264) including a cutting face (264) at a most proximal end of the shank (106) (figures 3-5), each cutting face (264) including at least one cutting edge (262, 268) (figures 3-5) arranged to rotate around the central longitudinal axis (102), wherein at least one cutting edge (262, 268) cuts when (considered functional) the bidirectional drill point bone screw (100) is rotated in a clockwise direction (¶31), and at least one cutting edge (262, 268) cuts when (considered functional) the bi-directional drill point bone screw (100) is rotated in a counter-clockwise direction, wherein rotary oscillation of the bi-directional drill point bone screw (100) about the longitudinal axis (102) of the shank (106) is suitable to form a predetermined diameter aperture in a bone (¶20).
Regarding claim 5, Bales discloses wherein the bi-directional drill point (figures 3-5) includes at least one additional web component (¶27) separated by open flutes (elements 250), each web component (figures 3-5) including a cutting face (264) at a most proximal end of the shank (106), each cutting face (264) including at least one cutting edge (262, 268) arranged to (i.e. capable of) rotate around the central longitudinal axis (102), wherein at least one cutting edge (262, 268) is arranged to (i.e. capable of) cut when the bidirectional drill point bone screw (100) is rotated in a clockwise direction (¶31) and at least one cutting edge (262, 268) is arranged to (i.e. capable of) cut when the bi-directional drill point bone screw (100) is rotated in a counter-clockwise direction (considered functional).
Regarding claim 6, Bales discloses wherein the bi-directional drill point (figures 3-5) includes at least two additional web components (¶27) separated by open flutes (elements 250), each web component (figures 3-5) including a cutting face (264) at a most proximal end of the shank (106), each cutting face (264) including at least one cutting edge (262, 268) arranged to (i.e. capable of) rotate around the central longitudinal axis (102), wherein at least two cutting edges (262, 268) are arranged to (i.e. capable of) cut when the bidirectional drill point bone screw (100) is rotated in a clockwise direction (¶31) and at least two cutting edges (262, 268) are arranged to (i.e. capable of) cut when (considered functional) the bi-directional drill point bone screw (100) is rotated in a counter-clockwise direction.
Regarding claim 7, Bales discloses wherein each cutting face (264) includes at least two cutting edges (262, 268) arranged to rotate around the central longitudinal axis (102), wherein at least one cutting edge (262, 268) on each cutting face (264) is arranged to (i.e. capable of) cut when (considered functional) the bi-directional drill point bone screw (100) is rotated in a clockwise direction (¶31) and at least one cutting edge (262, 268) on each cutting face (264) is arranged to (i.e. capable of) cut when (considered functional) the bi-directional drill point bone screw (100) is rotated in a counter-clockwise direction.
Regarding claim 11, Bales discloses wherein each cutting face (264) is a planar surface (figures 3-5).
Regarding claim 12, Bales discloses wherein each cutting face (264) is arranged at an angle (¶29 and figure 5) with respect to the longitudinal axis (102) to create a point angle (¶29), the point angle (¶29) reducing longitudinal pressure required to start an aperture (¶29).
Regarding claim 13, Bales discloses wherein the flutes (elements 250) 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 (100) is oscillated.
Regarding claim 14, Bales discloses wherein the at least one helical thread (116) is adapted to (i.e. capable of) cut threads in the aperture as the bi-directional drill point bone screw (100) is rotated into the aperture.
Regarding claim 15, Bales discloses wherein the at least one helical thread (116) is adapted to (i.e. capable of) compression form threads in the aperture as the bidirectional drill point bone screw (100) is rotated into the aperture.
Regarding claim 16, Bales discloses wherein the distal end of the shank (106) includes a tool socket (132) for cooperation with a driving tool (¶60) for rotation and/or oscillation of the shank (106).
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 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bales (US 2016/0120583) in view of DiVincenzo et al. (US 2018/0368898), herein referred to as DiVincenzo.
Regarding claim 2, Bales’s bi-directional drill point bone screw discloses all the features/element as claimed but lacks a detailed description on 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, DiVincenzo teaches at least one cutting edge (826) (figures 12 and 13) includes a face rake (822), the face rake (822) arranged perpendicularly with respect to a cutting face (820) extending along a respective web component (figures 12 and 13).
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 Bales’s at least one cutting edge with a face rake arranged perpendicularly with respect to the cutting face extending along a respective web component as taught by DiVincenzo, since such a modification would change the amount of force to cut the bone.
Claim(s) 3 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bales (US 2016/0120583).
Regarding claim 3, Bales’s bi-directional drill point bone screw discloses all the features/element 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.
However, it would be obvious to try by one of ordinary skill in the art as there are finite number of identified, predictable solutions with a reasonable expectation of success.
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 Bales’s at least one cutting edge with 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, since such a modification would be obvious to try by one of ordinary skill in the art and it appears the bone screw would perform equally well in cutting bone.
Regarding claim 4, Bales’s bi-directional drill point bone screw discloses all the features/element 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 more than ninety degrees with respect to the cutting face extending along a respective web component.
However, it would be obvious to try by one of ordinary skill in the art as there are finite number of identified, predictable solutions with a reasonable expectation of success.
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 Bales’s at least one cutting edge with 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 would be obvious to try by one of ordinary skill in the art and it appears the bone screw would perform equally well in cutting bone.
Claim(s) 8-10 and 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bales (US 2016/0120583) in view of Bono et al. (US 2019/0290290), herein referred to as Bono.
Regarding claim 8, Bales’s bi-directional drill point bone screw discloses all the features/element as claimed including a web (264), each web terminating at an outer periphery with a land (252) (figures 4 and 5), the land (252) constructed and arranged to control the diameter of the aperture created by the bi-directional drill point bone screw (100) 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 the each web component of Bales’s with a radiused root as taught by Bono, since such a modification would provide an alternative flute shape.
Regarding claim 9, the modified Bales’s bi-directional drill point bone screw has wherein the land (252 of Bales) is constructed and arranged to (i.e. capable of) burnish a bone surface as the aperture is sized.
Regarding clam 10, the modified Bales’s bi-directional drill point bone screw has wherein the land (252 of Bales) is constructed and arranged to (i.e. capable of) compress a bone surface as the aperture is sized.
Regarding claims 17, 18, Bales’s bi-directional drill point bone screw discloses all the features/element 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 Bales’s bi-directional drill point bone 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 bone screw having polyaxial movements.
Regarding claim 19, the modified Bales’s bi-directional drill point bone 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 Bales’s bi-directional drill point bone 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 filed December 16, 2025 have been fully considered but they are not persuasive.
Applicant’s arguments on pages 8-9, under 35 U.S.C. 102(a)(1) and 35 U.S.C. 103, of the Remarks are directed to claim 1 and the reference Bales. Applicant argues “There is no teaching or disclosure in Bales of any cutting surface that can cut when the screw of Bales is rotated in a opposite direction or counter-clockwise.” In response to applicant's argument that “There is no teaching or disclosure in Bales of any cutting surface that can cut when the screw of Bales is rotated in a opposite direction or counter-clockwise”, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. As generally claimed, Bales discloses at least one cutting edge (262, 268) cuts when (considered functional) the bi-directional drill point bone screw (100) is rotated in a counter-clockwise direction. The Examiner notes that a user is capable of rotating the screw in a counter-clockwise direction, so that it is capable of providing some amount of cutting even if it is not as much as when rotated in the clockwise direction. Thus, applicant is suggested to provide additional structure.
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.
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/SI MING KU/Primary Examiner, Art Unit 3775