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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Status of the Claims
This Office Action is responsive to the preliminary amendment filed October 28, 2024. As directed by the preliminary amendment: Claims 20-28 and 30-55 have been cancelled. Claims 1-19 and 29 have been amended and presently pending in this application.
Specification Objections
The disclosure is objected to because of the following informalities: In paragraph 38, elements 126A and 126B are labeled as both the leading portion. In paragraph 56, elements 126A and 126B are labeled as both the trailing portion. Appropriate correction is required.
Claim Objections
Claims 1 and 29 are objected to because of the following informalities: The phrase “the shaft” should be re-written as --the elongated shaft--. Appropriate correction is required.
Claim 4 is objected to because of the following informalities: In ll. 2, the phrase “the rate” should be re-written as --a rate--. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: In ll. 2, the term “canula” should be re-written as --cannula--. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: In ll. 3, the phrase “a second buttress” should be re-written as --a second buttress section--. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 1-19 and 29 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, 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.
Claims 1 and 29 recites the limitation "the orthopaedic screw" in ll. 13. There is insufficient antecedent basis for this limitation in these claims.
Regarding claim 2, ll. 2, the phrase “wherein the one or more screw threads” is unclear which of the two “the one or more screw threads” is being referenced, the “one or more screw threads of the threaded section” or the “one or more screw threads of the threaded head'. For purposes of examination, the Examiner has interpreted the phrase to be --the one or more screw threads of the threaded section--. Amendment and clarification are required.
Claim 2 recites the limitation "the tip portion" in ll. 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claims 3-19 are rejected on being dependent to a rejected base claim.
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, 3, 7, 15, and 29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Blitz (US 2020/0085477).
Regarding claim 1, Blitz discloses a compression screw (1110) (figures 37-39) 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 shaft (1114) comprising a threaded section (see figure 37 below) of the 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 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 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 orthopaedic screw (¶152), wherein a diameter of the buttress (1150) gradually increases from the proximal portion of the shaft (see figure 37 below) towards the head (1112).
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Regarding claim 3, Blitz discloses wherein the one or more screw threads (see figure 37 above) comprise a constant pitch (¶153).
Regarding claim 7, Blitz discloses wherein the length of the buttress section (1150) is less than 0.5 times L2 (figure 1).
Regarding claim 15, Blitz discloses wherein the shaft (1114) further comprises a non-threaded section (1145) having a length (figure 37) that extends between the proximal end portion of the shaft (see figure 37 above) and the trailing portion of the threaded section of the shaft (see figure 37 above).
Regarding claim 29, Blitz discloses a non-compression screw (¶15) comprising an elongate 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 shaft (1114) comprising a threaded section (see figure 37 above) of the 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 shaft (see figure 37 above) and extending from a leading tip portion of the shaft (see figure 37 above) to a trailing portion of the 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 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 orthopaedic screw (¶152), wherein a diameter of the buttress (1150) gradually increases from the proximal portion of the shaft (see figure 37 above) towards the head (1112).
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 Blitz (US 2020/0085477) 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 tip 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 tip 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 tip 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) 4-6, 8-13, 16, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blitz (US 2020/0085477).
Regarding claims 4, 5, 6, Blitz’s compression screw discloses all the features/elements as claimed but lacks a detailed description on wherein the 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 Blitz’s compression screw with wherein the 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 8, Blitz’s compression screw discloses all the features/elements as claimed but lacks a detailed description on comprising a cannula with a first opening through the threaded head and extending through the threaded head, buttress, and shaft and a second opening through the tip.
However, Blitz teaches in an alternative embodiment, a cannula (¶149 and figure 34) with a first opening (1036) through a threaded head (1012) and extending through the threaded head (1012), buttress (1050), and shaft (1014) and a second opening (figure 34) through a tip (1020).
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 a cannula with a first opening through the threaded head and extending through the threaded head, buttress, and shaft and a second opening through the tip as taught by Blitz, since such a modification would be configured to receive a guide wire therethrough to guide the bone screw to the correct implantation location (¶149).
Regarding claims 9, 10, 11, 12, 13, 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 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 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 16, the modified Blitz’s compression screw has wherein the length of the of the non-threaded section (1145) is greater than or equal to the length of the threaded section of the shaft (see figure 37 above).
Regarding claim 19, the modified Blitz’s compression screw has wherein the length of the non-threaded section (1145) is greater than length of the threaded head (1112) (figure 37).
Claim(s) 14 and 18 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 14, Blitz’s compression screw discloses all the features/elements as claimed but 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 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).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blitz 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 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 a 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 shaft as taught by Granberry, since such a modification would provide an alternative screw and considered a design choice.
Conclusion
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/SI MING KU/Primary Examiner, Art Unit 3775