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 June 12, 2026. As directed by the amendment: Claims 1, 4, and 8 have been amended. Claims 2, 3, 6, 7, 16, 19, 24, and 29 were cancelled. Claims 1, 4, 5, 8-15, 17, 18, 20-23, 25-28, and 30-32 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 § 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) 1, 4, 5, 8-13, 15, 17, 18, 20, 21, 23, 25-27, and 30-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Niver (US 2020/0015871) in view of Hollis et al. (US 2020/0100820), herein referred to as Hollis.
Regarding claim 1, Niver discloses a bone plate system (figures 18-22) comprising at least first and second screws (elements 150, 170), the second screw (170) comprising a non-superelastic material (e.g. titanium, ¶105), a bone plate (300) including at least first and second screw-receiving structures (elements 302, 304) respectively defining first and second holes (figures 18-22), the first and second holes (elements 302, 304) being respectively sized to (i.e. capable of) receive the first and second screws (elements 150, 170) (figures 21 and 22), wherein the second hole (302) is formed to receive the second screw (170) in an oblique or normal orientation (figure 21) relative to the first screw (150) and wherein a second screw-receiving portion (320) comprises an eccentric portion (320) sized to (i.e. capable of) engage a head of the second screw (170) and to bias the plate laterally (¶5).
Yet, Niver lacks the first screw comprising a superelastic material.
However, Hollis teaches a screw (1004) (¶72, ¶73, figures 24A-24J) comprising a superelastic material (¶5).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute Niver’s first screw with the first screw comprising a superelastic material as taught by Hollis, since such a modification is considered a mere substitution of one known screw for another to yield predictable results.
Thus, the modified Niver’s bone plate system has wherein the plate (300 of Niver) and screws (170 of Niver and 1004 of Hollis) are configured (i.e. capable of) such that when the bone plate (300 of Niver) is under tension with the first and second screws respectively received within the first and second holes (figures 18-22 of Niver), the first screw (1004 of Hollis) exerts a dynamic biasing force (due to the screw being made of a superelastic material) against at least a portion of the first receiving structure (304 of Niver) at an angle normal or oblique to an axis of the first screw (1004 of Hollis).
Regarding claim 4, the modified Niver’s bone plate system has further comprising at least a third screw (considered as a third bone screw, see figure 22 of Niver), the bone plate further comprising at least a third screw-receiving structure (considered as another element 304 of Niver) defining a third hole (figures 21 and 22 of Niver) sized to receive the third screw (figures 21 and 22 of Niver), the second hole (302 of Niver) being disposed in an intermediate region of the bone plate between the first hole (304 of Niver) and the third hole (considered as another element 304 of Niver).
Regarding claim 5, the modified Niver’s bone plate system discloses all the features/elements as claimed including further comprising at least fourth and fifth screws (considered as fourth and fifth bone screws, see figure 22 of Niver), the bone plate (300 of Niver) further comprising at least fourth and fifth screw-receiving structures (figures 21 and 22 of Niver) respectively defining fourth and fifth holes (figures 21 and 22 of Niver) respectively sized to receive the fourth and fifth screws (figures 21 and 22 of Niver), the fourth hole (considered as a fourth hole of Niver) being proximal to the first hole (304 of Niver), the fifth hole (considered as a fifth hole of Niver) being proximal to the third hole (considered as another element 304 of Niver).
Yet, the modified Niver’s bone plate lacks at least the fourth screw being a non-compression screw comprising a superelastic material.
However, Hollis teaches a screw (1004) (¶72, ¶73, figures 24A-24J) being a non-compression screw (figures 24A-24J) comprising a superelastic material (¶5).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute Niver’s fourth screw with a non-compression screw comprising a superelastic material as taught by Hollis, since such a modification is considered a mere substitution of one known screw for another to yield predictable results.
Thus, the modified Niver’s bone plate system has wherein the plate and screws are configured (i.e. capable of) such that the fourth screw (another element 1004 of Hollis), exerts a dynamic biasing force (due to the screw being made of a superelastic material) against at least a portion of the respective first or fourth receiving structure (elements 304 of Niver) at an angle normal or oblique to an axis of the fourth screw (another element 1004 of Hollis).
Regarding claim 8, the modified Niver’s bone plate system has wherein the eccentric portion (320 of Niver) comprises a ramp surface (¶78 of Niver) extending about an insertion axis of the second hole (figures 18-22 of Niver).
Regarding claim 9, the modified Niver’s bone plate system has wherein the first screw (1004 of Hollis) comprises nitinol (¶5 of Hollis).
Regarding claim 10, the modified Niver’s bone plate system has wherein the first screw is solid (figures 24A-24J of Hollis).
Regarding claim 11, the modified Niver’s bone plate system has wherein the first screw (1004 of Hollis) is a lag screw (figures 24I and 24J of Hollis) having an unthreaded portion (figures 24I and 24J of Hollis) adjacent a head of the screw (1004 of Hollis), the unthreaded portion (figures 24I and 24J of Hollis) sized to engage the first receiving structure to thereby screw exert the dynamic biasing force (¶72, ¶73 of Hollis).
Regarding claim 12, the modified Niver’s bone plate system has wherein the first and fourth screws (elements 1004 of Hollis) comprise nitinol (¶5 of Hollis).
Regarding claim 13, the modified Niver’s bone plate system has wherein the bone plate (300 of Niver) comprises titanium (¶105 of Niver).
Regarding claim 15, Niver discloses a bone fixation method comprising disposing a bone plate (300) over one or more of a joint between inferior bones or a fracture in an inferior fusion area (figure 22), the bone plate (300) including at least first and second screw-receiving structures (elements 302, 304) respectively defining first and second holes (figures 21 and 22), inserting a first screw (150) through the first hole (304) and screwing the first screw into bone (figure 22), and subsequently inserting a second screw (170) through the second hole (302) and screwing the second screw into bone (¶106 and figure 22), the second hole (302) receiving the second screw (170) in an oblique or normal orientation (figure 22) relative to the first screw (150) with the second screw (170) reaching across the one or more of the joint or the fracture (¶86), and the second screw (170) comprising a non-superelastic material (e.g. titanium, ¶105).
Yet, Niver lacks the first screw comprising a superelastic material.
However, Hollis teaches a screw (1004) (¶72, ¶73, figures 24A-24J) comprising a superelastic material (¶5).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute Niver’s first screw with the first screw comprising a superelastic material as taught by Hollis, since such a modification is considered a mere substitution of one known screw for another to yield predictable results.
Thus, the modified Niver’s bone fixation method has when tension applied through the bone plate (300 of Niver) between the first and second screws causing the first screw (1004 of Hollis) to exert a dynamic biasing force (due to the screw being made of a superelastic material) against at least a portion of the first receiving structure (304 of Niver) at an angle normal or oblique to an axis of the first screw (1004 of Hollis).
Regarding claim 17, the modified Niver’s bone fixation method has wherein the bone plate further comprises at least a third screw-receiving structure (considered as another element 304 of Niver) defining a third hole (figures 21 and 22 of Niver), the second hole (302 of Niver) being disposed in an intermediate region of the bone plate (300 of Niver) between the first hole (304 of Niver) and the third hole (considered as another element 304 of Niver), and the method further comprises inserting a third screw (considered as a third bone screw, see figure 22 of Niver) through the third hole (considered as another element 304 of Niver) and screwing the third screw into bone (figure 22 of Niver), the first and third screws being screwed into bone on opposite sides of the one or more of the joint or the fracture (figure 22 of Niver).
Regarding claim 18, the modified Niver’s bone fixation method discloses all the features/elements as claimed including wherein the bone plate (300 of Niver) further comprises at least fourth and fifth screw-receiving structures (figures 21 and 22 of Niver) respectively defining fourth and fifth holes (figures 21 and 22 of Niver), the fourth hole being proximal to the first hole (figures 21 and 22 of Niver), the fifth hole being proximal to the third hole (figures 21 and 22 of Niver), and the method further comprises inserting a fourth screw (considered as a fourth screw, see figure 22 of Niver) through the fourth hole (considered as a fourth hole of Niver) screwing the fourth screw into bone (figure 22 of Niver), inserting a fifth screw (considered as a fifth screw, see figure 22 of Niver) through the fifth hole (considered as a fifth hole of Niver) and screwing the fifth screw into bone (figure 22 of Niver).
Yet, Niver lacks the fourth screw comprising a superelastic material.
However, Hollis teaches a screw (1004) (¶72, ¶73, figures 24A-24J) comprising a superelastic material (¶5).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute Niver’s fourth screw with a screw comprising a superelastic material as taught by Hollis, since such a modification is considered a mere substitution of one known screw for another to yield predictable results.
Thus, the modified Niver’s bone fixation method has the tension applied through the bone plate (300 of Niver) causes the fourth screw (another element 1004 of Hollis) to exert a dynamic biasing force (due to the screw being made of a superelastic material) against at least a portion of the fourth receiving structure (element 304 of Niver) at an angle normal or oblique to the axis of the fourth screw (another element 1004 of Hollis).
Regarding claim 20, the modified Niver’s bone fixation method has wherein the first screw (1004 of Hollis) comprises nitinol (¶5 of Hollis).
Regarding claim 21, the modified Niver’s bone fixation method has wherein the first and fourth screws (elements 1004 of Hollis) comprise nitinol (¶5 of Hollis).
Regarding claim 23, Niver discloses a bone fixation method comprising disposing a bone plate (300) over one or more of a joint between inferior bones or a fracture in an inferior fusion area (figure 22), the bone plate (300) including at least first and second screw-receiving structures (elements 302, 304) respectively defining first and second holes (figures 21 and 22), the second screw-receiving structure (302) comprising an eccentric portion (320) (¶78) proximal the second hole (figures 18-22), inserting a first screw (150) through the first hole (304) and screwing the first screw into bone (figure 22), and subsequently inserting a second screw (170) through the second hole (302) and screwing the second screw into bone (¶106 and figure 22) at an oblique or normal orientation relative to the first screw (150), a head of the second screw (170) engaging the eccentric portion (320) via camming action (¶78) and compressing the one or more of the joint or the fracture as the second screw (170) is advanced into the bone (¶86 and figure 22), and the second screw (170) comprising a non-superelastic material (e.g. titanium, ¶105).
Yet, Niver lacks the first screw comprising a superelastic material.
However, Hollis teaches a screw (1004) (¶72, ¶73, figures 24A-24J) comprising a superelastic material (¶5).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute Niver’s first screw with the first screw comprising a superelastic material as taught by Hollis, since such a modification is considered a mere substitution of one known screw for another to yield predictable results.
Thus, the modified Niver’s bone fixation method has when tension applied through the bone plate (300 of Niver) between the first and second screws causing the first screw (1004 of Hollis) to exert a dynamic biasing force (due to the screw being made of a superelastic material) against at least a portion of the first receiving structure (304 of Niver) at an angle normal or oblique to the axis of the first screw (element 1004 of Hollis).
Regarding claim 25, the modified Niver’s bone fixation method has wherein the eccentric portion (320 of Niver) comprises a ramp surface (¶78 of Niver) extending about an insertion axis of the second hole (figures 18-22 of Niver).
Regarding claim 26, the modified Niver’s bone fixation method has wherein the first screw (1004 of Hollis) comprises nitinol (¶5 of Hollis).
Regarding claim 27, the modified Niver’s bone fixation method has wherein the first screw is solid (figures 24A-24J of Hollis).
Regarding claim 30, the modified Niver’s bone plate system has wherein the first screw (1004 of Hollis) is a non-compression screw (¶72, ¶73, figures 24A-24J of Hollis).
Regarding claims 31, 32, the modified Niver’s bone fixation method has wherein the first screw (1004 of Hollis) is a non-compression screw (¶72, ¶73, figures 24A-24J of Hollis).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Niver and Hollis as applied to claim 1 above, and further in view of Dayton et al. (US 2022/0226028), herein referred to as Dayton.
Regarding claim 14, the modified Niver’s kit comprises the bone plate system according to claim 1 (see claim 1 above) but lacks a container housing.
However, Dayton teaches a container housing (¶122).
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 the modified Niver’s kit with a container housing as taught by Dayton, since such a modification would hold the various surgical items (¶122).
Claim(s) 22 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Niver and Hollis as applied to claims above, and further in view of Hartdegen et al. (US 2017/0209193), herein referred to as Hartdegen.
Regarding claims 22, 28, the modified Niver’s bone fixation method discloses all the features/elements as claimed but lacks drilling first and second bore holes into bone, the first bore hole being drilled at a position to be proximal the portion of the first receiving structure where the first screw exerts the dynamic biasing force, and the second bore hole being drilled at a position to correspond to the second hole, the first screw being screwed into the first bore hole, and the second screw being screwed into the second bore hole.
However, Hartdegen teaches the step of drilling first and second bore holes (via element 150) into bone (¶132 and figure 5).
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 the modified Niver’s bone fixation method with the step of drilling first and second bore holes into bone as taught by Hartdegen, since such a step would prepare the bone to accept bone screws (¶132).
Thus, the modified Niver’s bone fixation method has the first bore hole (via element 150 of Hartdegen) being drilled at a position to be proximal the portion of the first receiving structure (304 of Niver) where the first screw (1004 of Hollis) exerts the dynamic biasing force (¶72, ¶73 of Hollis), and the second bore hole (via element 150 of Hartdegen) being drilled at a position to correspond to the second hole (302 of Niver), the first screw (1004 of Hollis) being screwed into the first bore hole (via element 150 of Hartdegen), and the second screw (170 of Niver) being screwed into the second bore hole (via element 150 of Hartdegen).
Response to Arguments
Applicant's arguments filed June 12, 2026 have been fully considered but they are not persuasive.
Applicant’s arguments on pages 8-13, under 35 U.S.C. 103, of the Remarks are directed the combination of references (Niver in view of Hollis). Applicant argues in part A that “The "mere substitution" rationale lacks the required rational underpinning” and “Hollis's element 1004 is not a conventional bone screw interchangeable with Niver's screws 105 as proposed in the Office Action”. However, the Examiner notes these are mere allegations. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute Niver’s first screw with the first screw comprising a superelastic material as taught by Hollis, since such a modification is considered a mere substitution of one known screw for another to yield predictable results (e.g. fixing a bone plate to bone(s)). The Examiner notes the reference Niver does not preclude using/substituting different types of screws.
Applicant argues in part B that “Proposed substitution would not result in the claimed bone plate system”, “The Office Action does not propose to import that bent geometry, the shelf-and-receiver structure that constrains it, or the inserter that enables it, instead proposing only a change of material. However, a straight screw made of nitinol, seated in Niver' s locking hole 304, would simply sit there. There is no elastically deformed configuration from which it would be recovering, and hence no "dynamic biasing force" normal or oblique to its axis” and argues the feature of “the plate and screws are configured such that when the bone plate is under tension with the first and second screws respectively received within the first and second holes, the first screw exerts a dynamic biasing force against at least a portion of the first receiving structure at an angle normal or oblique to an axis of the first screw”. The Examiner notes the modification was not only a change of material but substitution of one fastener for another. It is the modified Niver’s bone plate system that has wherein the plate (300 of Niver) and screws (170 of Niver and 1004 of Hollis) are configured (i.e. capable of) such that when the bone plate (300 of Niver) is under tension with the first and second screws respectively received within the first and second holes (figures 18-22 of Niver), the first screw (1004 of Hollis) exerts a dynamic biasing force (due to the screw being a superelastic screw) against at least a portion of the first receiving structure (304 of Niver) at an angle normal or oblique to an axis of the first screw (1004 of Hollis).
Applicant argues in Part C that “The subsequent placement and advancement of the non-superelastic second screw as claimed by Applicant tensions the plate and thereby triggers the biasing of the previously placed superelastic first screw at an angle normal or oblique to its axis. The Office Action identifies nothing in Niver or Hollis that discloses or suggests this sequence with the claimed screws. However, Niver discloses a method of screwing a first bone screw and a second bone screw into bone (claim 17) and states all methods described can be performed in any suitable order (¶106). Thus, the modified Niver’s method has when tension applied through the bone plate (300 of Niver) between the first and second screws causing the first screw (1004 of Hollis) to exert a dynamic biasing force (due to the screw being a superelastic screw) against at least a portion of the first receiving structure (304 of Niver) at an angle normal or oblique to an axis of the first screw (1004 of Hollis).
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
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