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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 September 22, 2026 has been entered.
Status of the Claims
This Office Action is responsive to the amendment filed September 22, 2026. As directed by the amendment: Claims 1 and 29 have been amended. Claims 2, 14, 20-28, and 30-55 have been cancelled. Claims 1, 3-13, 15-19, and 29 are presently pending in this application.
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.
Claim 3 is 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.
Regarding claim 3, ll. 2, the phrase “wherein the one or more screw threads comprise a constant pitch” is unclear whether applicant is referring to the threaded section or the threaded head. Amendment and clarification are required.
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, 3-13, and 15-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Palmer et al. (US 2016/0213412), herein referred to as Palmer, and in view of Gustilo (US 4,463,753), and further in view of Russell (US 146,023).
Regarding claim 1, Palmer discloses a compression screw (100) (¶65 and figure 1) comprising an elongated shaft (105) having a shaft length (figures 1, 1A) extending between a proximal portion (see figure 1A below) and a distal tip potion (see figure 1A below), the elongated shaft (105) comprising a threaded section (120) of the elongated shaft (105) having a length (figures 1, 1A) with a major diameter (figures 1, 1A) and a minor diameter (figures 1, 1A), the threaded section (120) having one or more screw threads (121) positioned in a spiral pattern (figure 1) on an outer surface of the elongated shaft (105) (figures 1, 1A) and extending from a leading tip portion of the elongated shaft (see figure 1A below) to a trailing portion of the elongated shaft (see figure 1A below), a non-threaded buttress (see figure 1A below) connecting a proximal portion of the elongated shaft (105) to a threaded head (110) with a head length (figures 1, 1A), the head (110) having a major diameter (see figure 1A below) and a minor diameter (see figure 1A below) with one or more screw threads (111) of constant pitch (figures 1, 1A, 9) being positioned in a spiral pattern (figures 1, 1A) on an outer surface of the head (110), such that the major diameter (MH) of the head (110) (figures 1, 1A, 9) > the major diameter (MT) of the threaded section (120) (figures 1, 1A, 9), the threaded head (110) being adapted to (i.e. capable of) accommodate a rotational tool (¶76) which provides the rotational force necessary to allow rotational movement of the compression screw (100) (¶76), wherein a diameter of the buttress (see figure 1A below) gradually increases from the proximal portion of the elongated shaft (105) towards the head (110) (see figure 1A below).
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Yet, Palmer lacks the minor diameter (mH) of the head > the minor diameter (mT) of the threaded section, wherein the minor diameter of the threaded section gradually decreases from the trailing portion of the threaded elongated shaft portion to the leading portion of the threaded elongated shaft portion.
However, Gustilo teaches a minor diameter (mH) of the head (11a) (figure 2) > the minor diameter (mT) of a threaded section (2) (figure 2), wherein the minor diameter of a threaded section (2) gradually decreases from a trailing portion of a threaded elongated shaft portion (2+3) (figure 2) to a leading portion of the threaded elongated shaft portion (2+3) (figure 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 Palmer’s compression screw with the minor diameter (mH) of the head > the minor diameter (mT) of the threaded section, wherein the minor diameter of the threaded section gradually decreases from the trailing portion of the threaded elongated shaft portion to the leading portion of the threaded elongated shaft portion as taught by Gustilo, since such a modification would provide an alternative compression screw that would cause compressions of the bone between the distal end and the taper (Abstract).
The modified Palmer’s compression screw further 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 elongated 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 an elongated 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 the modified Palmer’s compression screw with 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 elongated shaft as taught by Russell, since such a modification would provide an alternative screw and considered a design choice.
Regarding claim 3, the modified Palmer’s compression screw has wherein the one or more screw threads comprise a constant pitch (figures 1A and 9 of Palmer).
Regarding claims 4, 5, 6, the modified Palmer’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 the 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 0.06≤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 Palmer’s compression screw with wherein a rate of increase of the diameter of the buttress section per unit length of the 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 0.06≤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 Palmer’s compression screw has wherein length of the buttress section is less than 0.5 times L2 (see figure 1A of Palmer above).
Regarding claim 8, the modified Palmer’s compression screw has a cannula with a first opening (¶78 of Palmer) through the threaded head (110 of Palmer) and extending through the threaded head (see figure 1A of Palmer above), buttress (see figure 1A of Palmer above), and shaft (see figure 1A of Palmer above) and a second opening (¶78 of Palmer) through the tip (see figure 1A of Palmer above).
Regarding claims 9, 10, 11, 12, 13, the modified Palmer’s compression screw discloses all the features/elements as claimed including wherein the buttress (see figure 1A of Palmer above) comprises at least a first buttress section (see figure 1A of Palmer above) connected to the elongated shaft (105 of Palmer) and at least a second buttress section (see figure 1A of Palmer above) connected to the head (110 of Palmer) but lacks a detailed description on 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 Palmer’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 Palmer’s compression screw has wherein the elongated shaft further comprises a non-threaded section (130 of Palmer) having a length (figures 1, 1A of Palmer) that extends between the proximal end portion of the elongated shaft (see figure 1A of Palmer above) and the trailing portion of the threaded section of the elongated shaft (see figure 1A of Palmer above).
Regarding claim 16, the modified Palmer’s compression screw has wherein the length of the of the non-threaded section (130 of Palmer) is greater than or equal to the length of the threaded section of the elongated shaft (see figure 1A of Palmer above).
Regarding claim 17, the modified Palmer’s compression screw has wherein a diameter of the non-threaded section (130 of Palmer) is less than the instant diameter across any portion of the threaded section of the elongated shaft (see figure 1A of Palmer above).
Regarding claim 18, the modified Palmer’s compression screw has wherein the diameter of the non-threaded section (130 of Palmer) is less than the diameter of the threaded head (110 of Palmer) (figures 1, 1A of Palmer).
Regarding claim 19, the modified Palmer’s compression screw has wherein the length of the non-threaded section (130 of Palmer) is greater than length of the threaded head (110 of Palmer) (figures 1, 1A of Palmer).
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Palmer et al. (US 2016/0213412) in view of Gustilo (US 4,463,753) and further in view of Blitz (US 2020/0085477).
Regarding claim 29, Palmer discloses a screw (100) (¶65 and figure 1) comprising an elongated shaft (105) having a shaft length (figures 1, 1A) extending between a proximal portion (see figure 1A above) and a distal tip potion (see figure 1A above), the elongated shaft (105) comprising a threaded section (120) of the elongated shaft (105) having a length (figures 1, 1A) with a major diameter (figures 1, 1A) and a minor diameter (figures 1, 1A), the threaded section (120) having one or more screw threads (121) positioned in a spiral pattern (figure 1) on an outer surface of the elongated shaft (105) (figures 1, 1A) and extending from a leading tip portion of the elongated shaft (see figure 1A above) to a trailing portion of the elongated shaft (see figure 1A above), a non-threaded buttress (see figure 1A below) connecting a proximal portion of the elongated shaft (105) to a threaded head (110) with a head length (figures 1, 1A), the head (110) having a major diameter (see figure 1A below) and a minor diameter (see figure 1A below) with one or more screw threads (111) of constant pitch (figures 1, 1A, 9) being positioned in a spiral pattern (figures 1, 1A) on an outer surface of the head (110), such that (MH) > (MT) (figures 1, 1A, 9), the threaded head (110) being adapted to (i.e. capable of) accommodate a rotational tool (¶76) which provides the rotational force necessary to allow rotational movement of the screw (100) (¶76), wherein a diameter of the non-threaded buttress (see figure 1A above) gradually increases from the proximal portion of the elongated shaft (105) towards the head (110) (see figure 1A above), and wherein the minor diameter of the threaded head (figures 1A and 9) is constant along a length of the threaded head (110) (see figure 1A above) from a proximal end of the threaded head (110) (see figure 1A above) to the non-threaded buttress (see figure 1A above).
Yet, Palmer lacks a detailed description on (mH) > (mT).
However, Gustilo teaches a minor diameter (mH) of the head (11a) (figure 2) > a minor diameter (mT) of a threaded section (2) (figure 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 Palmer’s screw with (mH) of the head > (mT) as taught by Gustilo, since such a modification would provide an alternative screw.
The modified Palmer’s screw further lacks the screw being a non-compression screw.
However, Blitz teaches bone screws may be compression or non-compression (¶4).
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 Palmer’s screw (e.g. compression) with a non-compression screw as taught by Blitz, since such a modification is considered functional equivalents and wherein a non-compression screw holds the relative positioning of the bone segments without applying compressive force (¶155).
Response to Arguments
Applicant's arguments filed September 22, 2026 have been fully considered but they are not persuasive.
Applicant’s arguments on page 7-8, under 35 U.S.C. 102(a)(1), of the Remarks are directed to the amended claim 29 and the reference Blitz. Thus, the Examiner has relied upon the reference Palmer to teach applicant’s amended features, see Office Action above.
Applicant’s arguments on pages 8-12, under 35 U.S.C. 103, of the Remarks are directed to the amended claim 1 and the reference Blitz. Applicant’s arguments with respect to the reference Blitz has been considered but are moot because the new ground of rejection for amended claim 1 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
