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 preliminary amendment filed December 30, 2024. As directed by the preliminary amendment: Claims 1-21 have been cancelled. Claims 22-53 are presently pending in this application.
Information Disclosure Statement
The listing of references in the specification (e.g. ¶11) is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Drawings Objections
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “said lead thread plate and said at least one bottom thread do not form a continuous thread” in claims 22 and 44 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 34 and 35 are objected to because of the following informalities: In ll. 5, the phrase “any other open through” appears to be mis-written. Appropriate correction is 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) 22, 24, 26, 28, 30, 32, and 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Paolino et al. (US 2014/0277180), herein referred to as Paolino, and in view of Lopez et al. (US 2018/0064477), herein referred to as Lopez.
Regarding claim 22, Paolino discloses an orthopedic fixation device (110) (figures 1A-1F) for use in fracture fixation (¶83) comprising a bone plate body (110) that has a plurality of screw openings (elements 120) therethrough (¶86, ¶87), at least one of the screw openings (120) includes a lead thread plate (121) and at least one bottom thread (see figure 1B below) located below the lead thread plate (121), the lead thread plate (121) includes a plurality of lead recesses (elements 123) (figures 1A-1F), each of the lead recesses (elements 123) is spaced from one another by a wide portion (122), a top surface of the lead thread plate (121) is positioned parallel to a top surface (111) of the bone plate body (110) (figures 1A-1F).
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Yet, Paolino lacks the lead thread plate and the at least one bottom thread do not form a continuous thread.
However, Lopez teaches a lead thread plate (63) and the at least one bottom thread (46) do not form a continuous thread (¶49, figures 3A and 3B).
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 Paolino’s orthopedic fixation device with the lead thread plate and the at least one bottom thread do not form a continuous thread as taught by Lopez, since such a modification would provide an alternative variable angle hole.
Regarding claims 24, 26, 32, the modified Paolino’s orthopedic fixation device disclose all the features/elements as claimed but lacks a detailed description on wherein a minimum width of one or more of the lead recesses is less than a maximum width of the bottom threads located below the lead thread plate, wherein a maximum width of one or more of the wide portions of the lead thread plate is greater than a maximum width of the bottom threads located below the lead thread plate, wherein a maximum cross-sectional area of the top surface of the lead thread plate is greater than a maximum cross-sectional area of the at least one bottom thread under the lead thread plate.
However, Paolino teaches persons skilled in the art may make various changes (e.g. threads and/or indents, ¶101). Furthermore, the prior art discovering an optimum value 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 Paolino’s orthopedic fixation device with wherein a minimum width of one or more of the lead recesses is less than a maximum width of the bottom threads located below the lead thread plate, wherein a maximum width of one or more of the wide portions of the lead thread plate is greater than a maximum width of the bottom threads located below the lead thread plate, wherein a maximum cross-sectional area of the top surface of the lead thread plate is greater than a maximum cross-sectional area of the at least one bottom thread under the lead thread plate, since such a modification is considered optimization of the size of the prior art.
Regarding claim 28, the modified Paolino’s orthopedic fixation device has wherein the lead recesses (elements 123 of Paolino) are spaced symmetrically from one another about the screw opening (120 of Paolino) (figure 1D of Paolino), and the wide portions (elements 122 of Paolino) are spaced symmetrically from one another about the screw opening (120 of Paolino) (figure 1D of Paolino).
Regarding claim 30, the modified Paolino’s orthopedic fixation device has wherein the top surface of the lead thread plate (121 of Paolino) is recessed from the top surface (111 of Paolino) of the bone plate body (figure 1B of Paolino), a recess wall (see figure 1B of Paolino above) extends upwardly from the top surface of the lead thread plate (121 of Paolino) to the top surface (111 of Paolino) of the bone plate body (figure 1B of Paolino).
Regarding claim 40, the modified Paolino’s orthopedic fixation device has further includes a fastener arrangement (figure 2 of Paolino) that is configured to (i.e. capable of) be secured to one of said screw openings (120 of Paolino), said fastener arrangement (figure 2 of Paolino) includes a head portion (231 of Paolino) and a body portion (237 of Paolino) that is connected to the bottom of the head portion (231 of Paolino) and extends downwardly from the head portion (231 of Paolino), the head portion includes head threading (233 of Paolino) on an outer surface of at least a portion of the head portion (figure 2 of Paolino), the body portion (237 of Paolino) includes body threading (238 of Paolino) on an outer surface of at least a portion of the body portion (237 of Paolino), one or more of a) a pitch of said body threading is different from a pitch of said head threading, b) a thread length of said body threading (238 of Paolino) is different from a thread length of the head threading (233 of Paolino), c) a thread angle of said body threading is different from a thread angle of said head threading, d) a root depth of said body threading is different from a root depth of said head threading, and/or e) a lead of said body threading is different from a lead of said head threading.
Claim(s) 23, 25, 27, 29, 31, 33-35, 44, 46, 48, and 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Paolino (US 2014/0277180) in view of Lopez (US 2018/0064477) and further in view of Austin et al. (US 2008/0300637), herein referred to as Austin.
Regarding claim 23, the modified Paolino’s orthopedic fixation device disclose all the features/elements as claimed but lacks a detailed description on wherein the bone plate body is planar along a longitudinal axis of bone plate body, the bone plate body has a curved profile at each end of the bone plate body and a curved profile about a central longitudinal axis of the bone plate body.
However, Austin teaches wherein a bone plate body (12) is planar along a longitudinal axis of bone plate body (figure 3), the bone plate body (12) has a curved profile (figure 3) at each end of the bone plate body (12) (figure 3) and a curved profile (figure 3) about a central longitudinal axis of the bone plate body (figure 3).
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 orthopedic fixation device with the bone plate body is planar along a longitudinal axis of bone plate body, the bone plate body has a curved profile at each end of the bone plate body and a curved profile about a central longitudinal axis of the bone plate body as taught by Austin, since such a modification would match the contour of the bone for which bone is to be treated (¶3).
Regarding claim 25, 27, 33, the modified Paolino’s orthopedic fixation device disclose all the features/elements as claimed but lacks a detailed description on wherein a minimum width of one or more of the lead recesses is less than a maximum width of the bottom threads located below the lead thread plate, wherein a maximum width of one or more of the wide portions of the lead thread plate is greater than a maximum width of the bottom threads located below the lead thread plate, wherein a maximum cross-sectional area of the top surface of the lead thread plate is greater than a maximum cross-sectional area of the at least one bottom thread under the lead thread plate.
However, Paolino teaches persons skilled in the art may make various changes (e.g. threads and/or indents, ¶101). Furthermore, the prior art discovering an optimum value 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 Paolino’s orthopedic fixation device with wherein a minimum width of one or more of the lead recesses is less than a maximum width of the bottom threads located below the lead thread plate, wherein a maximum width of one or more of the wide portions of the lead thread plate is greater than a maximum width of the bottom threads located below the lead thread plate, wherein a maximum cross-sectional area of the top surface of the lead thread plate is greater than a maximum cross-sectional area of the at least one bottom thread under the lead thread plate, since such a modification is considered optimization of the size of the prior art.
Regarding claim 29, the modified Paolino’s orthopedic fixation device has wherein the lead recesses (elements 123 of Paolino) are spaced symmetrically from one another about the screw opening (120 of Paolino) (figure 1D of Paolino), and the wide portions (elements 122 of Paolino) are spaced symmetrically from one another about the screw opening (120 of Paolino) (figure 1D of Paolino).
Regarding claim 31, the modified Paolino’s orthopedic fixation device has wherein the top surface of the lead thread plate (121 of Paolino) is recessed from the top surface (111 of Paolino) of the bone plate body (figure 1B of Paolino), a recess wall (see figure 1B of Paolino above) extends upwardly from the top surface of the lead thread plate (121 of Paolino) to the top surface (111 of Paolino) of the bone plate body (see figure 1B of Paolino above).
Regarding claims 34, 35, the modified Paolino’s orthopedic fixation device disclose all the features/elements as claimed but lacks wherein the bone plate body includes multiple arcuate regions on each side of the bone plate body such that a width of the bone plate body varies along a longitudinal length of the bone plate body, a location of the screw openings in the bone plate body represents a larger width of the bone plate body than regions of the bone plate body that are absent the screw openings or any other open through the bone plate body.
However, Austin teaches a bone plate body (1100) includes multiple arcuate regions (figure 86) on each side of the bone plate body (1100) such that a width of the bone plate body (1100) varies along a longitudinal length of the bone plate body (1100) (figure 86), a location of the screw openings (elements 1120) in the bone plate body (1100) represents a larger width of the bone plate body (1100) (figure 86) than regions of the bone plate body (1100) that are absent the screw openings or any other open through the bone plate body (figure 86).
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 Paolino’s orthopedic fixation device with wherein the bone plate body includes multiple arcuate regions on each side of the bone plate body such that a width of the bone plate body varies along a longitudinal length of the bone plate body, a location of the screw openings in the bone plate body represents a larger width of the bone plate body than regions of the bone plate body that are absent the screw openings or any other open through the bone plate body as taught by Austin, since such a modification would provide an alternative plate shape, wherein Paolino clearly contemplates various changes in the shape may be made (¶101).
Regarding claim 44, Paolino discloses an orthopedic fixation device (110) (figures 1A-1F) for use in fracture fixation (¶83) comprising a bone plate body (110) that has a plurality of screw openings (elements 120) therethrough (¶86, ¶87), at least one of the screw openings (120) includes a lead thread plate (121) and at least one bottom thread (figures 1A-1F) located below the lead thread plate (121), the lead thread plate (121) includes a plurality of lead recesses (elements 123) (figures 1A-1F), each of the lead recesses (elements 123) is spaced from one another by a wide portion (122), a top surface of the lead thread plate (121) is positioned parallel to a top surface (111) of the bone plate body (110) (figures 1A-1F), the top surface of the lead thread plate (121) is recessed from the top surface (111) of said bone plate body (110) (see figure 1B above), a recess wall (see figure 1B above) extends upwardly from the top surface of the lead thread plate (121) to the top surface (111) of the bone plate body (see figure 1B above).
Yet, Paolino lacks the lead thread plate and the at least one bottom thread do not form a continuous thread.
However, Lopez teaches a lead thread plate (63) and the at least one bottom thread (46) do not form a continuous thread (¶49, figures 3A and 3B).
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 Paolino’s orthopedic fixation device with the lead thread plate and the at least one bottom thread do not form a continuous thread as taught by Lopez, since such a modification would provide an alternative variable angle hole.
The modified Paolino’s orthopedic fixation device further lacks the bone plate body is planar along a longitudinal axis of the bone plate body, the bone plate body has a curved profile along a lateral axis of the bone plate body, the bone plate body has a curved profile at each end of the bone plate body.
However, Austin teaches wherein a bone plate body (12) is planar along a longitudinal axis of bone plate body (figure 3), the bone plate body (12) has a curved profile (figure 3) at each end of the bone plate body (12) (figure 3) and a curved profile (figure 3) about a central longitudinal axis of the bone plate body (figure 3).
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 Paolino’s orthopedic fixation device with the bone plate body is planar along a longitudinal axis of bone plate body, the bone plate body has a curved profile at each end of the bone plate body and a curved profile about a central longitudinal axis of the bone plate body as taught by Austin, since such a modification would match the contour of the bone for which bone is to be treated (¶3).
Regarding claim 46, the modified Paolino’s orthopedic fixation device discloses all the features/elements as claimed but lacks a detailed description on wherein a minimum width of one or more of the lead recesses is less than a maximum width of the bottom threads located below the lead thread plate, a maximum width of one or more of the wide portions of the lead thread plate is greater than a maximum width of the bottom threads located below the lead thread plate, the lead recesses are spaced symmetrically about the screw opening from one another, the wide portions are spaced symmetrically about the screw opening from one another, a maximum cross-sectional area of the top surface of the lead thread plate is greater than a maximum cross-sectional area the bottom threads under the lead thread plate.
However, Paolino teaches persons skilled in the art may make various changes (e.g. threads and/or indents, ¶101). Furthermore, the prior art discovering an optimum value 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 Paolino’s orthopedic fixation device with wherein a minimum width of one or more of the lead recesses is less than a maximum width of the bottom threads located below the lead thread plate, a maximum width of one or more of the wide portions of the lead thread plate is greater than a maximum width of the bottom threads located below the lead thread plate, the lead recesses are spaced symmetrically about the screw opening from one another, the wide portions are spaced symmetrically about the screw opening from one another, a maximum cross-sectional area of the top surface of the lead thread plate is greater than a maximum cross-sectional area the bottom threads under the lead thread plate, since such a modification is considered optimization of the size of the prior art.
Regarding claims 48, the modified Paolino’s orthopedic fixation device disclose all the features/elements as claimed but lacks wherein the bone plate body includes multiple arcuate regions on each side of the bone plate body such that a width of the bone plate body varies along a longitudinal length of the bone plate body, a location of the screw openings in the bone plate body represents a larger width of the bone plate body than regions of the bone plate body that are absent the screw openings or any other open through the bone plate body.
However, Austin teaches a bone plate body (1100) includes multiple arcuate regions (figure 86) on each side of the bone plate body (1100) such that a width of the bone plate body (1100) varies along a longitudinal length of the bone plate body (1100) (figure 86), a location of the screw openings (elements 1120) in the bone plate body (1100) represents a larger width of the bone plate body (1100) (figure 86) than regions of the bone plate body (1100) that are absent the screw openings or any other open through the bone plate body (figure 86).
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 Paolino’s orthopedic fixation device with wherein the bone plate body includes multiple arcuate regions on each side of the bone plate body such that a width of the bone plate body varies along a longitudinal length of the bone plate body, a location of the screw openings in the bone plate body represents a larger width of the bone plate body than regions of the bone plate body that are absent the screw openings or any other open through the bone plate body as taught by Austin, since such a modification would provide an alternative plate shape, wherein Paolino clearly contemplates various changes in the shape may be made (¶101).
Regarding claim 50, the modified Paolino’s orthopedic fixation device has further includes a fastener arrangement (figure 2 of Paolino) that is configured to (i.e. capable of) be secured to one of said screw openings (120 of Paolino), said fastener arrangement (figure 2 of Paolino) includes a head portion (231 of Paolino) and a body portion (237 of Paolino) that is connected to the bottom of the head portion (231 of Paolino) and extends downwardly from the head portion (231 of Paolino), the head portion includes head threading (233 of Paolino) on an outer surface of at least a portion of the head portion (figure 2 of Paolino), the body portion (237 of Paolino) includes body threading (238 of Paolino) on an outer surface of at least a portion of the body portion (237 of Paolino), one or more of a) a pitch of said body threading is different from a pitch of said head threading, b) a thread length of said body threading (238 of Paolino) is different from a thread length of the head threading (233 of Paolino), c) a thread angle of said body threading is different from a thread angle of said head threading, d) a root depth of said body threading is different from a root depth of said head threading, and/or e) a lead of said body threading is different from a lead of said head threading.
Claim(s) 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Paolino and Lopez as applied to claim 22 above, and further in view of Roth (US 2019/0117827).
Regarding claim 36, the modified Paolino’s orthopedic fixation device disclose all the features/elements as claimed but lacks wherein the bone plate body is at least partially formed of a refractory alloy or a metal alloy that includes at least 15 awt.% rhenium.
However, Roth teaches wherein a medical device (e.g. bone plate body, ¶8) is at least partially formed of a refractory alloy or a metal alloy that includes at least 15 awt.% rhenium (¶9).
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 Paolino’s orthopedic fixation device with wherein the bone plate body is at least partially formed of a refractory alloy or a metal alloy that includes at least 15 awt.% rhenium as taught by Roth, since such a novel alloy improves one or more properties (e.g., strength, durability, hardness, biostability, bendability, coefficient of friction, radial strength, flexibility, tensile strength, tensile elongation, longitudinal lengthening, stress-strain properties, improved recoil properties, radiopacity, heat sensitivity, biocompatibility, improved fatigue life, crack resistance, crack propagation resistance, etc.) of such medical device (¶6).
Claim(s) 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Paolino, Lopez, Austin as applied to claims above, and further in view of Roth (US 2019/0117827).
Regarding claim 37, the modified Paolino’s orthopedic fixation device disclose all the features/elements as claimed but lacks wherein the bone plate body is at least partially formed of a refractory alloy or a metal alloy that includes at least 15 awt.% rhenium.
However, Roth teaches wherein a medical device (e.g. bone plate body, ¶8) is at least partially formed of a refractory alloy or a metal alloy that includes at least 15 awt.% rhenium (¶9).
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 Paolino’s orthopedic fixation device with wherein the bone plate body is at least partially formed of a refractory alloy or a metal alloy that includes at least 15 awt.% rhenium as taught by Roth, since such a novel alloy improves one or more properties (e.g., strength, durability, hardness, biostability, bendability, coefficient of friction, radial strength, flexibility, tensile strength, tensile elongation, longitudinal lengthening, stress-strain properties, improved recoil properties, radiopacity, heat sensitivity, biocompatibility, improved fatigue life, crack resistance, crack propagation resistance, etc.) of such medical device (¶6).
Claim(s) 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Paolino and Lopez as applied to claim 22 above, and further in view of Kay et al. (US 2014/0296921), herein referred to as Kay.
Regarding claim 38, the modified Paolino’s orthopedic fixation device disclose all the features/elements as claimed including wherein the bone plate body (110 of Paolino) includes a non-threaded screw opening (¶87 of Paolino), the non-threaded screw opening is absent a lead thread plate and threading (¶87 of Paolino). Yet, the modified Paolino’s orthopedic fixation device lacks the non-threaded screw opening is positioned between two screw openings, the non-threaded screw opening includes a sloped surface that slopes downwardly from the top surface of the bone plate body, the sloped surface does not fully encircle the non-threaded screw opening.
However, Kay teaches a non-threaded screw opening (14) is positioned between two screw openings (elements 24) (figure 1), the non-threaded screw opening (14) includes a sloped surface (figures 1 and 2) that slopes downwardly from a top surface of a bone plate body (10) (figures 1 and 2), the sloped surface (figures 1 and 2) does not fully encircle the non-threaded screw opening (14) (¶64).
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 Paolino’s orthopedic fixation device having a non-threaded screw opening with the non-threaded screw opening is positioned between two screw openings, the non-threaded screw opening includes a sloped surface that slopes downwardly from the top surface of the bone plate body, the sloped surface does not fully encircle the non-threaded screw opening as taught by Kay, since such a modification would provide the option for compression (¶64).
Claim(s) 39 and 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Paolino, Lopez, Austin, Roth as applied to claims above, and further in view of Kay (US 2014/0296921).
Regarding claim 39, the modified Paolino’s orthopedic fixation device disclose all the features/elements as claimed including wherein the bone plate body (110 of Paolino) includes a non-threaded screw opening (¶87 of Paolino), the non-threaded screw opening is absent a lead thread plate and threading (¶87 of Paolino). Yet, the modified Paolino’s orthopedic fixation device lacks the non-threaded screw opening is positioned between two screw openings, the non-threaded screw opening includes a sloped surface that slopes downwardly from the top surface of the bone plate body, the sloped surface does not fully encircle the non-threaded screw opening.
However, Kay teaches a non-threaded screw opening (14) is positioned between two screw openings (elements 24) (figure 1), the non-threaded screw opening (14) includes a sloped surface (figures 1 and 2) that slopes downwardly from a top surface of a bone plate body (10) (figures 1 and 2), the sloped surface (figures 1 and 2) does not fully encircle the non-threaded screw opening (14) (¶64).
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 Paolino’s orthopedic fixation device having a non-threaded screw opening with the non-threaded screw opening is positioned between two screw openings, the non-threaded screw opening includes a sloped surface that slopes downwardly from the top surface of the bone plate body, the sloped surface does not fully encircle the non-threaded screw opening as taught by Kay, since such a modification would provide the option for compression (¶64).
Regarding claim 41, the modified Paolino’s orthopedic fixation device has further includes a fastener arrangement (figure 2 of Paolino) that is configured to (i.e. capable of) be secured to one of said screw openings (120 of Paolino), said fastener arrangement (figure 2 of Paolino) includes a head portion (231 of Paolino) and a body portion (237 of Paolino) that is connected to the bottom of the head portion (231 of Paolino) and extends downwardly from the head portion (231 of Paolino), the head portion includes head threading (233 of Paolino) on an outer surface of at least a portion of the head portion (figure 2 of Paolino), the body portion (237 of Paolino) includes body threading (238 of Paolino) on an outer surface of at least a portion of the body portion (237 of Paolino), one or more of a) a pitch of said body threading is different from a pitch of said head threading, b) a thread length of said body threading (238 of Paolino) is different from a thread length of the head threading (233 of Paolino), c) a thread angle of said body threading is different from a thread angle of said head threading, d) a root depth of said body threading is different from a root depth of said head threading, and/or e) a lead of said body threading is different from a lead of said head threading.
Claim(s) 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Paolino and Lopez as applied to claims 22 and 40 above, and further in view of Elsbury (US 2011/0015681).
Regarding claim 42, the modified Paolino’s orthopedic fixation device disclose all the features/elements as claimed but lacks wherein the head portion of the fastener arrangement includes a tapered portion that forms a tapered profile of the head portion along a central axis of the head portion, the head threading is at least partially located on the tapered portion, the tapered portion constitutes 20-100% of a longitudinal length of the head portion, an angle of taper of the tapered portion is constant along 60-100% of the tapered portion, the head threading on the tapered portion has a tapered profile.
However, Elsbury teaches a head portion (42) of a fastener arrangement (figure 10) includes a tapered portion (figure 10) that forms a tapered profile of the head portion (42) along a central axis of the head portion (figure 10), the head threading is at least partially located on the tapered portion (figure 10), the tapered portion constitutes 20-100% of a longitudinal length of the head portion (42) (figure 10), an angle of taper of the tapered portion is constant along 60-100% of the tapered portion (figure 10), the head threading on the tapered portion has a tapered profile (figure 10).
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 Paolino’s orthopedic fixation device having a fastener arrangement with the head portion of the fastener arrangement includes a tapered portion that forms a tapered profile of the head portion along a central axis of the head portion, the head threading is at least partially located on the tapered portion, the tapered portion constitutes 20-100% of a longitudinal length of the head portion, an angle of taper of the tapered portion is constant along 60-100% of the tapered portion, the head threading on the tapered portion has a tapered profile as taught by Elsbury, since such a modification would provide an alternative fastener.
Claim(s) 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Paolino, Lopez, Austin, Roth Kay, as applied to claims above, and further in view of Elsbury (US 2011/0015681).
Regarding claim 43, the modified Paolino’s orthopedic fixation device disclose all the features/elements as claimed but lacks wherein the head portion of the fastener arrangement includes a tapered portion that forms a tapered profile of the head portion along a central axis of the head portion, the head threading is at least partially located on the tapered portion, the tapered portion constitutes 20-100% of a longitudinal length of the head portion, an angle of taper of the tapered portion is constant along 60-100% of the tapered portion, the head threading on the tapered portion has a tapered profile.
However, Elsbury teaches a head portion (42) of a fastener arrangement (figure 10) includes a tapered portion (figure 10) that forms a tapered profile of the head portion (42) along a central axis of the head portion (figure 10), the head threading is at least partially located on the tapered portion (figure 10), the tapered portion constitutes 20-100% of a longitudinal length of the head portion (42) (figure 10), an angle of taper of the tapered portion is constant along 60-100% of the tapered portion (figure 10), the head threading on the tapered portion has a tapered profile (figure 10).
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 Paolino’s orthopedic fixation device having a fastener arrangement with the head portion of the fastener arrangement includes a tapered portion that forms a tapered profile of the head portion along a central axis of the head portion, the head threading is at least partially located on the tapered portion, the tapered portion constitutes 20-100% of a longitudinal length of the head portion, an angle of taper of the tapered portion is constant along 60-100% of the tapered portion, the head threading on the tapered portion has a tapered profile as taught by Elsbury, since such a modification would provide an alternative fastener.
Claim(s) 45, 47, 49, and 51 is/are rejected under 35 U.S.C. 103 as being unpatentable over Paolino, Lopez, Austin as applied to claim 44 above, and further in view of Kay (US 2014/0296921).
Regarding claim 45, the modified Paolino’s orthopedic fixation device disclose all the features/elements as claimed including wherein the bone plate body (110 of Paolino) includes a non-threaded screw opening (¶87 of Paolino), the non-threaded screw opening is absent a lead thread plate and threading (¶87 of Paolino). Yet, the modified Paolino’s orthopedic fixation device lacks the non-threaded screw opening is positioned between two screw openings, the non-threaded screw opening includes a sloped surface that slopes downwardly from the top surface of the bone plate body, the sloped surface does not fully encircle the non-threaded screw opening.
However, Kay teaches a non-threaded screw opening (14) is positioned between two screw openings (elements 24) (figure 1), the non-threaded screw opening (14) includes a sloped surface (figures 1 and 2) that slopes downwardly from a top surface of a bone plate body (10) (figures 1 and 2), the sloped surface (figures 1 and 2) does not fully encircle the non-threaded screw opening (14) (¶64).
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 Paolino’s orthopedic fixation device having a non-threaded screw opening with the non-threaded screw opening is positioned between two screw openings, the non-threaded screw opening includes a sloped surface that slopes downwardly from the top surface of the bone plate body, the sloped surface does not fully encircle the non-threaded screw opening as taught by Kay, since such a modification would provide the option for compression (¶64).
Regarding claim 47, the modified Paolino’s orthopedic fixation device discloses all the features/elements as claimed but lacks a detailed description on wherein a minimum width of one or more of the lead recesses is less than a maximum width of the bottom threads located below the lead thread plate, a maximum width of one or more of the wide portions of the lead thread plate is greater than a maximum width of the bottom threads located below the lead thread plate, the lead recesses are spaced symmetrically about the screw opening from one another, the wide portions are spaced symmetrically about the screw opening from one another, a maximum cross-sectional area of the top surface of the lead thread plate is greater than a maximum cross-sectional area the bottom threads under the lead thread plate.
However, Paolino teaches persons skilled in the art may make various changes (e.g. threads and/or indents, ¶101). Furthermore, the prior art discovering an optimum value 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 Paolino’s orthopedic fixation device with wherein a minimum width of one or more of the lead recesses is less than a maximum width of the bottom threads located below the lead thread plate, a maximum width of one or more of the wide portions of the lead thread plate is greater than a maximum width of the bottom threads located below the lead thread plate, the lead recesses are spaced symmetrically about the screw opening from one another, the wide portions are spaced symmetrically about the screw opening from one another, a maximum cross-sectional area of the top surface of the lead thread plate is greater than a maximum cross-sectional area the bottom threads under the lead thread plate, since such a modification is considered optimization of the size of the prior art.
Regarding claims 49, the modified Paolino’s orthopedic fixation device disclose all the features/elements as claimed but lacks wherein the bone plate body includes multiple arcuate regions on each side of the bone plate body such that a width of the bone plate body varies along a longitudinal length of the bone plate body, a location of the screw openings in the bone plate body represents a larger width of the bone plate body than regions of the bone plate body that are absent the screw openings or any other open through the bone plate body.
However, Austin teaches a bone plate body (1100) includes multiple arcuate regions (figure 86) on each side of the bone plate body (1100) such that a width of the bone plate body (1100) varies along a longitudinal length of the bone plate body (1100) (figure 86), a location of the screw openings (elements 1120) in the bone plate body (1100) represents a larger width of the bone plate body (1100) (figure 86) than regions of the bone plate body (1100) that are absent the screw openings or any other open through the bone plate body (figure 86).
Regarding claim 51, the modified Paolino’s orthopedic fixation device has further includes a fastener arrangement (figure 2 of Paolino) that is configured to (i.e. capable of) be secured to one of said screw openings (120 of Paolino), said fastener arrangement (figure 2 of Paolino) includes a head portion (231 of Paolino) and a body portion (237 of Paolino) that is connected to the bottom of the head portion (231 of Paolino) and extends downwardly from the head portion (231 of Paolino), the head portion includes head threading (233 of Paolino) on an outer surface of at least a portion of the head portion (figure 2 of Paolino), the body portion (237 of Paolino) includes body threading (238 of Paolino) on an outer surface of at least a portion of the body portion (237 of Paolino), one or more of a) a pitch of said body threading is different from a pitch of said head threading, b) a thread length of said body threading (238 of Paolino) is different from a thread length of the head threading (233 of Paolino), c) a thread angle of said body threading is different from a thread angle of said head threading, d) a root depth of said body threading is different from a root depth of said head threading, and/or e) a lead of said body threading is different from a lead of said head threading.
Claim(s) 52 is/are rejected under 35 U.S.C. 103 as being unpatentable over Paolino, Lopez, Austin, as applied to claims above, and further in view of Elsbury (US 2011/0015681).
Regarding claim 52, the modified Paolino’s orthopedic fixation device disclose all the features/elements as claimed but lacks wherein the head portion of the fastener arrangement includes a tapered portion that forms a tapered profile of the head portion along a central axis of the head portion, the head threading is at least partially located on the tapered portion, the tapered portion constitutes 20-100% of a longitudinal length of the head portion, an angle of taper of the tapered portion is constant along 60-100% of the tapered portion, the head threading on the tapered portion has a tapered profile.
However, Elsbury teaches a head portion (42) of a fastener arrangement (figure 10) includes a tapered portion (figure 10) that forms a tapered profile of the head portion (42) along a central axis of the head portion (figure 10), the head threading is at least partially located on the tapered portion (figure 10), the tapered portion constitutes 20-100% of a longitudinal length of the head portion (42) (figure 10), an angle of taper of the tapered portion is constant along 60-100% of the tapered portion (figure 10), the head threading on the tapered portion has a tapered profile (figure 10).
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 Paolino’s orthopedic fixation device having a fastener arrangement with the head portion of the fastener arrangement includes a tapered portion that forms a tapered profile of the head portion along a central axis of the head portion, the head threading is at least partially located on the tapered portion, the tapered portion constitutes 20-100% of a longitudinal length of the head portion, an angle of taper of the tapered portion is constant along 60-100% of the tapered portion, the head threading on the tapered portion has a tapered profile as taught by Elsbury, since such a modification would provide an alternative fastener.
Claim(s) 53 is/are rejected under 35 U.S.C. 103 as being unpatentable over Paolino, Lopez, Austin, Kay as applied to claims above, and further in view of Elsbury (US 2011/0015681).
Regarding claim 52, the modified Paolino’s orthopedic fixation device disclose all the features/elements as claimed but lacks wherein the head portion of the fastener arrangement includes a tapered portion that forms a tapered profile of the head portion along a central axis of the head portion, the head threading is at least partially located on the tapered portion, the tapered portion constitutes 20-100% of a longitudinal length of the head portion, an angle of taper of the tapered portion is constant along 60-100% of the tapered portion, the head threading on the tapered portion has a tapered profile.
However, Elsbury teaches a head portion (42) of a fastener arrangement (figure 10) includes a tapered portion (figure 10) that forms a tapered profile of the head portion (42) along a central axis of the head portion (figure 10), the head threading is at least partially located on the tapered portion (figure 10), the tapered portion constitutes 20-100% of a longitudinal length of the head portion (42) (figure 10), an angle of taper of the tapered portion is constant along 60-100% of the tapered portion (figure 10), the head threading on the tapered portion has a tapered profile (figure 10).
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 Paolino’s orthopedic fixation device having a fastener arrangement with the head portion of the fastener arrangement includes a tapered portion that forms a tapered profile of the head portion along a central axis of the head portion, the head threading is at least partially located on the tapered portion, the tapered portion constitutes 20-100% of a longitudinal length of the head portion, an angle of taper of the tapered portion is constant along 60-100% of the tapered portion, the head threading on the tapered portion has a tapered profile as taught by Elsbury, since such a modification would provide an alternative fastener.
Conclusion
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/SI MING KU/Primary Examiner, Art Unit 3775
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