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 April 2, 2026. As directed by the amendment: Claims 1, 2, 4, 8, 9, 13, 15-18, and 29 have been amended. Claims 14, 20-28, and 30-55 have been cancelled. Claims 1-13, 15-19, and 29 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) 29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Blitz (US 2020/0085477).
Regarding claim 29, Blitz discloses a non-compression screw (¶4, ¶15, ¶156) comprising an elongate shaft (1114) having a shaft length (figure 37) extending between a proximal portion (see figure 37 below) and a distal tip potion (see figure 37 below), the elongated shaft (1114) comprising a threaded section (see figure 37 below) of the elongated shaft (1114) having a length (figure 37) with a major diameter (see figure 37 below) and a minor diameter (see figure 37 below), the threaded section (see figure 37 below) having one or more screw threads (1144) positioned in a spiral pattern (see figure 37 below) on an outer surface of the shaft (see figure 37 below) and extending from a leading tip portion of the elongated shaft (see figure 37 below) to a trailing portion of the shaft (see figure 37 below), a non-threaded buttress (1150) connecting a proximal portion of the elongated shaft (see figure 37 below) to a threaded head (1112) with a head length (figures 37-39), the head (1112) having a major diameter (see figure 37 below) and a minor diameter (see figure 37 below) with one or more screw threads (figures 37-39) of constant pitch (¶153) being positioned in a spiral pattern on an outer surface of the head (figures 37-39), such that MH > MT (¶151-¶153) and mH > mT (¶151-¶153), the threaded head (1112) being adapted to (i.e. capable of) accommodate a rotational tool (¶152) which provides the rotational force necessary to allow rotational movement of the non-compression screw (e.g. compression-neutral, ¶4, ¶156), wherein a diameter of the buttress (1150) gradually increases from the proximal portion of the elongated shaft (see figure 37 below) towards the head (1112).
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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, 3-13, 15, 16, 18, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blitz (US 2020/0085477) in view of Gustilo (US 4,463,753).
Regarding claim 1, Blitz discloses a compression screw (1110) (figures 37-39) comprising an elongated shaft (1114) having a shaft length (figure 37) extending between a proximal portion (see figure 37 above) and a distal tip potion (see figure 37 above), the elongated shaft (1114) comprising a threaded section (see figure 37 above) of the elongated shaft (1114) having a length (figure 37) with a major diameter (see figure 37 above) and a minor diameter (see figure 37 above), the threaded section (see figure 37 above) having one or more screw threads (1144) positioned in a spiral pattern (see figure 37 above) on an outer surface of the elongated shaft (see figure 37 above) and extending from a leading tip portion of the elongated shaft (see figure 37 above) to a trailing portion of the elongated shaft (see figure 37 above), a non-threaded buttress (1150) connecting a proximal portion of the shaft (see figure 37 above) to a threaded head (1112) with a head length (figures 37-39), the head (1112) having a major diameter (see figure 37 above) and a minor diameter (see figure 37 above) with one or more screw threads (figures 37-39) of constant pitch (¶153) being positioned in a spiral pattern on an outer surface of the head (figures 37-39), such that the major diameter (MH) of the head > the major diameter (MT) of the threaded section (¶151-¶153) and the minor diameter (mH) of the head > the minor diameter (mT) of the threaded section (¶151-¶153), the threaded head (1112) being adapted to (i.e. capable of) accommodate a rotational tool (¶152) which provides the rotational force necessary to allow rotational movement of the compression screw (¶4, ¶152), wherein a diameter of the buttress (1150) gradually increases from the proximal portion of the elongated shaft (see figure 37 above) towards the head (1112).
Yet, Blitz lacks wherein the minor diameter of the threaded section gradually decreases from the trailing portion of the threaded shaft portion to the leading portion of the threaded shaft portion.
However, Gustilo teaches a minor diameter of a threaded section (2a) (figures 1 and 2) gradually decreases from a trailing portion of the threaded shaft portion (2a) to a leading portion of the threaded shaft portion (2a) (figures 1 and 2).
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 Blitz’s compression screw with wherein the minor diameter of the threaded section gradually decreases from the trailing portion of the threaded shaft portion to the leading portion of the threaded shaft portion as taught by Gustilo, since such a modification would cause compressions of the bone between the distal end and the taper (Abstract).
Regarding claim 3, the modified Blitz’s compression screw has wherein the one or more screw threads (see figure 37 of Blitz above) comprise a constant pitch (¶153 of Blitz).
Regarding claims 4, 5, 6, the modified Blitz’s compression screw discloses all the features/elements as claimed but lacks a detailed description on wherein a rate of increase of the diameter of the buttress section per unit length of buttress is in accordance with the following equation: DB≥1.5x, wherein the diameter of the buttress section varies per unit length of the buttress is in accordance with the following equation: DB = Ax2-Bx wherein 0.5≤A≤1.0; and 0.05≤B≤0.1, wherein 0.6≤A≤0.9, and 0.6≤B≤0.09.
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 provide the modified Blitz’s compression screw with wherein a rate of increase of the diameter of the buttress section per unit length of buttress is in accordance with the following equation: DB≥1.5x, wherein the diameter of the buttress section varies per unit length of the buttress is in accordance with the following equation: DB = Ax2-Bx wherein 0.5≤A≤1.0; and 0.05≤B≤0.1, wherein 0.6≤A≤0.9, and 0.6≤B≤0.09, since such a modification is considered optimization of the size of the prior art in order to suite the specific needs of a patient since not all bones are the same size or require implants that are the same size.
Regarding claim 7, the modified Blitz’s compression screw has wherein the length of the buttress section (1150 of Blitz) is less than 0.5 times L2 (figure 1 of Blitz).
Regarding claim 8, the modified Blitz’s compression screw has a cannula (¶155 and figure 37 of Blitz) with a first opening (1136 of Blitz) through the threaded head (1112 of Blitz) and extending through the threaded head (¶155 of Blitz), buttress (1150 of Blitz), and shaft (1114 of Blitz) and a second opening (figure 37 of Blitz) through the tip (1120 of Blitz).
Regarding claims 9, 10, 11, 12, 13, the modified Blitz’s compression screw discloses all the features/elements as claimed including wherein the buttress comprises at least a first buttress section (considered as a first portion of element 1150) connected to the elongated shaft (1114) and at least a second buttress section (considered as a second portion of element 1150) connected to the head (1112). Yet, Blitz lacks such that a radius of curvature of an outer surface of the first buttress section is in the range of 0.4 mm and 2.2 mm and wherein the second buttress section comprises an inclined flat surface which is inclined towards the threaded head at an acute angle relative to a longitudinal axis of the compression screw, wherein the outer surface of the second buttress section is inclined towards the threaded head at an angle of less than ninety degrees relative to a longitudinal axis of the elongate shaft, wherein the outer surface of the second buttress section is inclined towards the threaded head at an angle of less than sixty degrees relative to a longitudinal axis of the elongate shaft, wherein the outer surface of the second buttress section is inclined towards the threaded head at an angle of forty-five degrees relative to a longitudinal axis of the elongate shaft, such that a radius of curvature of an outer surface of the first buttress section is in the range of 0.4 mm and 2.2 mm and wherein a radius of curvature of an outer surface of the second buttress section is in the range of 0.4 mm and 0.7 mm.
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 the modified Blitz’s compression screw with a radius of curvature of an outer surface of the first buttress section is in the range of 0.4 mm and 2.2 mm and wherein the second buttress section comprises an inclined flat surface which is inclined towards the threaded head at an acute angle relative to a longitudinal axis of the compression screw, wherein the outer surface of the second buttress section is inclined towards the threaded head at an angle of less than ninety degrees relative to a longitudinal axis of the elongate shaft, wherein the outer surface of the second buttress section is inclined towards the threaded head at an angle of less than sixty degrees relative to a longitudinal axis of the elongate shaft, wherein the outer surface of the second buttress section is inclined towards the threaded head at an angle of forty-five degrees relative to a longitudinal axis of the elongate shaft, such that a radius of curvature of an outer surface of the first buttress section is in the range of 0.4 mm and 2.2 mm and wherein a radius of curvature of an outer surface of the second buttress section is in the range of 0.4 mm and 0.7 mm, since such a modification is considered optimization of the size of the prior art and considered a design choice.
Regarding claim 15, the modified Blitz’s compression screw has wherein the shaft (1114 of Blitz) further comprises a non-threaded section (1145 of Blitz) having a length (figure 37 of Blitz) that extends between the proximal end portion of the shaft (see figure 37 of Blitz above) and the trailing portion of the threaded section of the shaft (see figure 37 of Blitz above).
Regarding claim 16, the modified Blitz’s compression screw has wherein the length of the of the non-threaded section (1145 of Blitz) is greater than or equal to the length of the threaded section of the shaft (see figure 37 of Blitz above).
Regarding claim 18, the modified Blitz’s compression screw has wherein the diameter of the non-threaded section (1145 of Blitz) is less than the diameter of the threaded head (1112 of Blitz) (see figure 37 of Blitz above).
Regarding claim 19, the modified Blitz’s compression screw has wherein the length of the non-threaded section (1145 of Blitz) is greater than length of the threaded head (1112 of Blitz) (figure 37 of Blitz).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blitz and Gustilo as applied to claim 1 above, and further in view of Russell (US 146,023).
Regarding claim 2, Blitz’s compression screw discloses all the features/elements as claimed but lacks wherein the one or more screw threads of the threaded section comprise a varying pitch that decreases from the leading portion towards the trailing portion of the shaft.
However, Russell teaches one or more screw threads (figure 1) of a threaded section comprise a varying pitch (page 1) that decreases from a leading portion (page 1 and figure 1) towards a trailing portion of a shaft (page 1 and figure 1).
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 Blitz’s compression screw with one or more screw threads of the threaded section comprise a varying pitch that decreases from the leading portion towards the trailing portion of the shaft as taught by Russell, since such a modification would provide an alternative screw and considered a design choice.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blitz and Gustilo as applied to claims above, and further in view of Granberry et al. (US 9,687,256), herein referred to as Granberry.
Regarding claim 17, the modified Blitz’s compression screw discloses all the features/elements as claimed but lacks wherein a diameter of the non-threaded section is less than the instant diameter across any portion of the threaded section of the elongated shaft.
However, Granberry teaches wherein a diameter of the non-threaded section (110) (figures 7c and 7d) is less than an instant diameter across any portion of the threaded section of an elongated shaft (166) (figures 7c and 7d).
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 modified Blitz’s compression screw with a diameter of the non-threaded section is less than the instant diameter across any portion of the threaded section of the elongated shaft as taught by Granberry, since such a modification would provide an alternative screw and considered a design choice.
Response to Arguments
Applicant's arguments filed April 2, 2026 have been fully considered but they are not persuasive.
Applicant’s arguments on pages 9-15, under 35 U.S.C. 102(a)(1) and 35 U.S.C. 103, of the Remarks are directed to the amended claims 1 and 29 and the references Blitz and Gustilo.
Applicant argues on page 9-10 of the Remarks that amended claim 29 is not anticipated by Blitz because it is directed to” a non-compression screw”. However, the Examiner respectfully disagrees because Blitz discloses a non-compression screw (e.g. compression-neutral screws, holds the relative positioning of the bone segments without applying compressive force, ¶4, ¶15, ¶156).
Applicant argues on pages 10-15, that “In other words, Blitz focuses on the design of the head of the bone screw to achieve its technical solution” and “Thus, the invention of Gustilo focuses on the geometry of the shank portion, which contradicts the invention of Blitz, which as per above focuses on the design of the head of the bone screw”. In response to applicant's arguments against the references individually (e.g. Blitz and Gustilo), one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. The Examiner notes that the reference Gustilo was specifically used to teach a minor diameter of a threaded section (2a) (figures 1 and 2) gradually decreases from a trailing portion of the threaded shaft portion (2a) to a leading portion of the threaded shaft portion (2a) (figures 1 and 2). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Blitz’s compression screw with wherein the minor diameter of the threaded section gradually decreases from the trailing portion of the threaded shaft portion to the leading portion of the threaded shaft portion as taught by Gustilo, since such a modification would cause compressions of the bone between the distal end and the taper (Abstract).
Applicant argues/alleges “Accordingly, one of ordinary skill in the art would not combine these two documents to result in Applicant's claimed invention. Instead, the resulting combination would be inoperable or would be contrary to its intended purpose because of the contradictory nature of the two documents”. However, the reference Blitz discloses in paragraph 4 that “The bone screws described herein may be provided in a variety of length and/or diameter (both major and minor) dimensions as needed” and “are suitable in a variety of orthopedic procedures”. The reference Blitz does not preclude such a modification would be inoperable.
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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