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 .
Response to Amendment
This Office Action is responsive to the amendment filed on 18 May 2026. Claims 1, 10, and 18 have been amended and claims 19-22 are newly added. Claims 1-22 currently stand pending in the application.
The amendments to the claims are sufficient to overcome the rejections under 35 U.S.C. 112(a) listed in the previous action, which are correspondingly withdrawn.
Response to Arguments
Applicant's arguments with respect to the rejections under 35 U.S.C. 103 have been fully considered but they are not persuasive. Applicant contends that Eisermann (US 6,423,067) discloses a shank portion that varies in diameter and is thus not cylindrical. Examiner respectfully submits that Eisermann discloses that shank portion 70 varies in diameter, and that shank portion 70 is between proximal end 30 and distal end 60, i.e. proximal end 30, distal end 60, and shank portion 70 are distinct and separate, as shown in FIG. 1. Distal end 60 is shown in FIG. 1 as being substantially cylindrical, and is not included in the “variable diameter shank portion 70.” Eisermann’s shaft, particularly distal end 60, is also as cylindrical as the instant application, which recites “a substantially cylindrical body portion.”
Applicant further contends that neither Eisermann nor Erickson (US 7,998,180) teach that the predefined radiographic identifier indicates that the bone screw has reverse thread. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
As to Terrill (US 2015/0250514), Applicant contends that there is no indication that the predefined radiographic identifier indicates that the bone screw has reverse thread. Instead, the implants of Terrill are described as colored, coded, or otherwise marked to make it easier for the surgeon to identify the type and size of the implant. Applicant contends that the phrase “otherwise marked” cannot be interpreted to denote any sort of marker, but rather markers that a person of ordinary skill in the art, reading the reference, would at once envisage. Applicant further contends that Terrill does not teach radiographic markers. Examiner respectfully submits that, as to Terrill, a person of skill in the art, reading the reference, would ‘at once envisage’ a radiographic marker as a type of mark, at least because it is called a “marker” and because it is referenced by Terrill in the immediately preceding sentence as a type of marker that the screw could include (Terrill, par. [0027]). Terrill does not recite that the ‘otherwise marked’ could not include radiographic markers, and makes no remarks critical of use of radiographic markers as identifying markers, as required to demonstrate a teaching away. Obviousness does not require that the motivation be the best option, only that it be a suitable option from which the prior art did not teach away.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention in view of Erickson (US 7,998,180) to comprise Eisermann’s (US 6,423,067) screw of a radiolucent material with a predefined radiographic identifier comprising beads of increased radiographic density embedded in the body portion so that the surgical site can be better viewed while the radiographic identifiers with increased radiographic density still allow identification of the screws to ensure they are properly placed. The radiographic identifiers allow the reverse thread bone screw of Eisermann to be identifiable in situ by x-ray. As taught by Terrill, marking an implant to indicate the type of implant, i.e. a reverse threaded bone screw, makes it easier for the surgeon to identify the correct screw to use (and since the screw includes a radiographic identifier as modified in view of Erickson, this identifier can be predefined or determined in advance as associated with the reverse thread bone screw, as could any type of marker provided on the screw be associated with its distinguishing features), and from the disclosures of both Terrill and Erickson, a person of ordinary skill would ‘at once envisage’ a radiographic marker as a type of marker that is applicable in the surgical art.
The teaching by Terrill that any of a variety of types of marks would be used to identify the implant to make it easier for the surgeon by reducing time and potential error, is applicable to Eisermann/Erickson because it would have been obvious to indicate to the surgeon that the screw is reverse threaded in order to ensure that the reverse threaded screw is appropriate for the implantation site and that the correct implantation procedure is followed (e.g. correct rotational force applied), and since modification in view of Erickson already provided the screw with a radiographic identifier, so that utilizing that radiographic identifier to also indicate features about the screw by defining the relationship before the surgery (i.e. screws with this particular radiographic identifier have reverse thread) would have been obvious.
Drawings
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 predefined radiographic identifier is located adjacent to a base of the reverse thread, distal to the conical front end (claim 22) must be shown or the feature(s) canceled from the claim(s). FIGS. 3-4 of the instant application, which show a conical front end 325/425 and a carbide band 327/427 which may be attached to the inner core adjacent to a base of the reverse thread (par. [0040] of the publication), does not show the carbide band/radiographic identifier distal to the conical front end; distal to the front end would be distal to the body of the screw. 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 21 and 22 are objected to because of the following informalities: improper antecedence. Appropriate correction is required. The following amendments are suggested:
Claim 21 / line 4: “fully inserted into the drive coupling.”
Claim 22 / line 2: “a base of the reverse angle threads,”
Claim Rejections - 35 USC § 112
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 19-22 are rejected under 35 U.S.C. 112(b) 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.
As to claims 19-21, the limitation “the unique drive coupling” renders the claims indefinite because it lacks proper antecedent basis in the claims. Claim 1 recites a drive coupling but not a unique drive coupling. For examination purposes, the limitation will be interpreted as the drive coupling.
As to claim 22, the limitation “distal to the conical front end” renders the claims indefinite because it lacks proper antecedent basis in the claims. Claim 1 recites distal and proximal ends of the body portion, but not a front end, nor a conical front end. For examination purposes, the limitation will be interpreted as deleted.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-7, 10-18, and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. US 6,423,067 to Eisermann, in view of U.S. Patent No. US 7,998,180 to Erickson et al. (hereinafter, “Erickson”) and U.S. Patent Application Publication No. US 2015/0250514 to Terrill et al. (hereinafter, “Terrill”).
As to claim 1, Eisermann discloses a reverse thread bone screw comprising a body portion having a substantially cylindrical section (60; shown in FIG. 1 as substantially cylindrical, and not included in the “variable diameter” shank portion 70, col. 4 / lines 14-16) along a longitudinal axis with reverse angle threads (left-handed threads) formed around a distal end of the body portion (col. 2 / lines 29-31), FIG. 1, and a drive coupling (42 and 44) (col. 4 / lines 18-20, col. 6 / lines 12-27 and 45-67) formed in a proximal end of the body portion, FIGs. 1 and 4B.
As to claim 2, Eisermann discloses the reverse thread bone screw of claim 1, wherein the reverse thread bone screw is a reverse thread hip lag screw (interpreted as language of intended use; the reverse thread lag screw, col. 1 / lines 20-32, is fully capable of being used in a hip or any bone with a fracture).
As to claim 3, Eisermann discloses the reverse thread bone screw of claim 2, wherein the drive coupling is configured to accept a reciprocally-shaped driving tool (100; the tool is reciprocally, or inversely related, to the shape of the driving mechanism because they are negatives of each other) (col. 5 / line 47 – col. 6 / line 27), FIGs. 4A-5.
As to claim 4, Eisermann discloses the reverse thread bone screw of claim 2, wherein the reciprocally-shaped driving tool is configured to drive and remove the reverse thread hip lag screw in directions opposite to those of a non-reverse thread hip lag screw (since driving and removing a screw with left-handed threads would occur in directions opposite to the driving and removing of a screw with right-handed threads; since Eisermann discloses the threads may be left-handed, the disclosed tool must be compatible to and usable with a left-handed thread screw, and therefore would drive and remove the left-handed screw in the required directions; the thread 44 of the drive coupling would be in a compatible direction for the tool to engage the screw with the left-handed external threads).
As to claim 5, Eisermann discloses the reverse thread bone screw of claim 4, wherein the drive coupling formed in the proximal end of the body portion is not compatible with screw driving tools for non-reverse threaded screws (where compatible means existing without conflict; the drive coupling would conflict with standard tools for non-reverse threaded screws like a flat head screwdriver particularly if the sizing of the standard tool is too large or the standard tool edges would conflict with the driving mechanism).
As to claim 7, Eisermann discloses the reverse thread bone screw of claim 2, wherein the reverse angle threads are formed around a fixed length of the distal end of the body portion, FIG. 1.
As to claim 20, Eisermann discloses the reverse thread bone screw of claim 1, wherein the unique drive coupling includes an elongated hexagonal-shaped configuration (portion 42 of the drive coupling is hexagonal in cross-section, col. 5 / lines 12-15, and elongated along a longitudinal axis), FIGS. 1-2.
As to claim 21, Eisermann discloses the reverse thread bone screw of claim 1, wherein the unique drive coupling includes at least two different depth levels (different depths of 42 and 44), wherein each level has a different configuration (42 and 44 have different configurations of hexagonal and threaded, col. 6 / lines 45-65) configured to prevent advancement or removal unless a driving tool is fully inserted into the coupling (interpreted as language of intended use; the configurations of the drive coupling are fully capable of preventing advancement or removal unless a driving tool is fully inserted into the coupling to engage both levels for complete seating and engagement of the tool in the coupling).
Although Eisermann discloses that the screw may be comprised of radiopaque and radiolucent materials to create a marker readily observed during imaging (col. 6 / line 66 – col. 7 / line 8), Eisermann is silent as to a predefined radiographic identifier adhered to or embedded in the body portion, such that the reverse thread bone screw is identifiable in situ by x-ray (claim 1); wherein the predefined radiographic identifier comprises a carbide ring connected at a base of the reverse angle threads; or one or more beads of increased radiographic density connected to the body portion (claim 6); and wherein the predefined radiographic identifier is located adjacent to a base of the reverse thread, distal to the conical front end (claim 22).
Erickson teaches a radiolucent bone screw (col. 4 / line 62-63), in the same field of endeavor of surgical screws, comprising a predefined radiographic identifier (44, the identifier is predefined because it is defined in advance, during manufacture), FIG. 5, embedded in a body portion of the screw (along the longitudinal axis) (col. 4 / line 66 – col. 5 / line 15), such that the bone screw is identifiable in situ by x-ray (col. 1 / lines 21-44; col. 3 / line 66 – col. 4 / line 2; col. 6 / lines 4-16), wherein the predefined radiographic identifier comprises one or more beads of increased radiographic density connected to the body portion, FIG. 5, so that the radiolucent bone screw minimizes interference with the radiograph so that the surgical site can be better viewed while the radiographic identifiers with increased radiographic density still allow identification of the screws to ensure they are properly placed (col. 6 / lines 4-16). Erickson teaches wherein the predefined radiographic identifier is located adjacent to a base of the thread (the radiographic identifier is adjacent to or nearby the base of the thread, and it is closer to the base of the thread than the crest of the thread), distal to the conical front end (the distal radiographic identifier 44 is distal to a conical portion of the front end of the screw).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to comprise Eisermann’s bone screw of a radiolucent material with a predefined radiographic identifier comprising beads of increased radiographic density embedded in the body portion, as taught by Erickson, so that the surgical site can be better viewed while the radiographic identifiers with increased radiographic density still allow identification of the screws to ensure they are properly placed. The radiographic identifiers allow the reverse thread bone screw of Eisermann to be identifiable in situ by x-ray, where the term identifiable means distinguishable – the bone screw of Eisermann is identifiable or distinguishable in situ by x-ray because the radiographic identifiers are visible by x-ray and the presence of the bone screw, with reverse threads as disclosed by Eisermann and known by the practitioner to have radiographic identifiers therein, can therefore be seen on the image and distinguished from its surroundings. As taught by Erickson, the beads of increased radiographic density may be embedded at ends of the body portion to allow the surgeon to observe the length of the screw and determine when the screw is properly seated. The distal bead of increased radiographic density is adjacent to the base of the reverse thread in Eisermann because, as taught by Erickson, it is adjacent to or nearby the base of the thread, and it is closer to the base of the thread than the crest of the thread. The distal bead of increased radiographic density is distal to a conical portion of the front end of the head of the screw.
Eisermann is silent as to the predefined radiographic identifier indicating that the bone screw has reverse thread.
Terrill teaches a bone screw includes a radiographic identifier and that the implant is marked to indicate the type of the screw to make it easier for the surgeon to identify the correct screw to use (par. [0027]).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the radiographic identifier, incorporated in Eisermann’s screw in view of Erickson, indicate that the bone screw has reverse thread, since Terrill teaches that marking an implant to indicate the type of implant, i.e. a reverse threaded bone screw, makes it easier for the surgeon to identify the correct screw to use. Since the screw includes a radiographic identifier as modified above, this identifier can be predefined or determined in advance as associated with the reverse thread bone screw. For example, the surgeon would be informed that the screws with the radiographic identifier are those with reverse thread while other screws do not have such an identifier and/or are made of different materials, or the particular location of the identifier on the screw would indicate that that screw has reverse thread. As above, the reverse thread bone screw disclosed in Eisermann is identifiable in situ by x-ray due to the modification above to include radiographic identifiers which are visible and therefore identifiable by x-ray; because the radiographic identifier indicates that the bone screw has reverse thread due to the modification in view of Terrill (or at least that the bone screw that is identified by visible radiographic identifier has reverse thread), the fact that the bone screw has reverse thread would also be identifiable in situ by x-ray.
As to claim 10, Eisermann discloses a reverse thread screw comprising a body portion having a substantially cylindrical section (60; shown in FIG. 1 as substantially cylindrical, and not included in the “variable diameter” shank portion 70, col. 4 / lines 14-16) along a longitudinal axis with reverse angle threads (left-handed threads) formed around a distal end of the body portion (col. 2 / lines 29-31), FIG. 1, and the reverse angle threads extending a length of the body portion to terminate adjacent to a proximal end of the body portion (where the screw comprises a threaded distal end and an unthreaded proximal end, where the ends comprise portions of the screw length, the threads extend the length of the body portion, along the distal end, to terminate adjacent to the unthreaded proximal end), and a drive coupling (42 and 44) (col. 4 / lines 18-20, col. 6 / lines 12-27 and 45-67) formed in the proximal end of the body portion, FIGs. 1 and 4B.
As to claim 11, Eisermann discloses the reverse thread screw of claim 10, wherein the drive coupling is configured to accept a reciprocally-shaped driving tool (100; the tool is reciprocally, or inversely related, to the shape of the drive coupling because they are negatives of each other) (col. 5 / line 47 – col. 6 / line 27), FIGs. 4A-5.
As to claim 12, Eisermann discloses the reverse thread screw of claim 10, wherein the reciprocally-shaped driving tool is configured to drive and remove the reverse thread screw in directions opposite to a non-reverse thread screw (since driving and removing a screw with left-handed threads would occur in directions opposite to the driving and removing of a screw with right-handed threads; since Eisermann discloses the threads may be left-handed, the disclosed tool must be compatible to and usable with a left-handed thread screw, and therefore would drive and remove the left-handed screw in the required directions; the thread 44 of the drive coupling would be in a compatible direction for the tool to engage the screw with the left-handed external threads).
As to claim 13, Eisermann discloses the reverse thread screw of claim 10, wherein the drive coupling formed in the proximal end of the body portion is not compatible with screw driving tools for non-reverse threaded screws (where compatible means existing without conflict; the unique drive coupling would conflict with standard tools for non-reverse threaded screws like a flat head screwdriver particularly if the sizing of the standard tool is too large or the standard tool edges would conflict with the drive coupling).
Although Eisermann discloses that the screw may be comprised of radiopaque and radiolucent materials to create a marker readily observed during imaging (col. 6 / line 66 – col. 7 / line 8), Eisermann is silent as to a predefined radiographic identifier adhered to or embedded in the body portion such that the reverse thread screw is identifiable in situ by x-ray (claim 10); wherein the predefined radiographic identifier comprises a carbide ring connected circumferentially around and to the body portion; or one or more beads of increased radiographic density connected to the body portion (claim 14); and wherein the one or more beads of increased radiographic density are arranged longitudinally along the body portion (claim 16).
Erickson teaches a radiolucent bone screw (col. 4 / line 62-63), in the same field of endeavor of surgical screws, comprising a predefined radiographic identifier (44, the identifier is predefined because it is defined in advance, during manufacture), FIG. 5, embedded in a body portion of the screw (along the longitudinal axis) (col. 4 / line 66 – col. 5 / line 15), such that the screw is identifiable in situ by x-ray (col. 1 / lines 21-44; col. 3 / line 66 – col. 4 / line 2; col. 6 / lines 4-16), wherein the predefined radiographic identifier comprises one or more beads of increased radiographic density connected to the body portion and arranged longitudinally along the body portion, FIG. 5, so that the radiolucent bone screw minimizes interference with the radiograph so that the surgical site can be better viewed while the radiographic identifiers with increased radiographic density still allow identification of the screws to ensure they are properly placed (col. 6 / lines 4-16).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to comprise Eisermann’s screw of a radiolucent material with a predefined radiographic identifier comprising beads of increased radiographic density embedded in the body portion and arranged longitudinally along the body portion, as taught by Erickson, so that the surgical site can be better viewed while the radiographic identifiers with increased radiographic density still allow identification of the screws to ensure they are properly placed. The radiographic identifiers allow the reverse thread screw of Eisermann to be identifiable in situ by x-ray, where the term identifiable means distinguishable – the screw of Eisermann is identifiable or distinguishable in situ by x-ray because the radiographic identifiers are visible by x-ray and the presence of the screw, with reverse threads as disclosed by Eisermann and known by the practitioner to have radiographic identifiers therein, can therefore be seen on the image and distinguished from its surroundings. As taught by Erickson, the beads of increased radiographic density may be embedded at ends of the body portion and arranged longitudinally to allow the surgeon to observe the length of the screw and determine when the screw is properly seated. Because Eisermann in view of Erickson teach that the predefined radiographic identifier comprises the one or more beads of increased radiographic density, and because the limitations in claim 14 are presented in the alternative, the limitations of claim 15, further defining the carbide ring presented in the alternative in claim 14, are considered unpatentable over Eisermann in view of Erickson.
Eisermann is silent as to the predefined radiographic identifier indicating that the screw has reverse thread.
Terrill teaches a bone screw includes a radiographic identifier and that the implant is marked to indicate the type of the screw to make it easier for the surgeon to identify the correct screw to use (par. [0027]).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the radiographic identifier, incorporated in Eisermann’s screw in view of Erickson, indicate that the bone screw has reverse thread, since Terrill teaches that marking an implant to indicate the type of implant, i.e. a reverse threaded bone screw, makes it easier for the surgeon to identify the correct screw to use. Since the screw includes a radiographic identifier as modified above, this identifier can be predefined or determined in advance as associated with the reverse thread bone screw. For example, the surgeon would be informed that the screws with the radiographic identifier are those with reverse thread while other screws do not have such an identifier and/or are made of different materials, or the particular location of the identifier on the screw would indicate that that screw has reverse thread. As above, the reverse thread screw disclosed in Eisermann is identifiable in situ by x-ray due to the modification above to include radiographic identifiers which are visible and therefore identifiable by x-ray; because the radiographic identifier indicates that the screw has reverse thread due to the modification in view of Terrill (or at least that the screw that is identified by visible radiographic identifier has reverse thread), the fact that the screw has reverse thread would also be identifiable in situ by x-ray.
As to claim 17, Eisermann in view of Erickson and Terrill (“Eisermann/Erickson/Terrill”) disclose the one or more beads of increased radiographic density but are silent as to the one or more beads of increased radiographic density arranged circumferentially around the body portion.
Erickson teaches that the bone screw may have an area of increased radiographic density arranged circumferentially around the body portion to properly observe when the screw is fully seated (col. 6 / lines 9-27), FIG. 8A, and that the radiographic identifiers can have a variety of shapes and be bonded to or molded or embedded into the screw (col. 4 / lines 10-19).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to adhere or embed the beads of increased radiographic density circumferentially around the body portion of Eisermann’s screw, since as taught by Erickson, depending on the application it would be useful to be able to view the circumference of the screw to observe when the screw is properly seated.
As to claim 18, Eisermann discloses a reverse thread screw kit comprising a reverse thread screw comprising a body portion having a substantially cylindrical section (60; shown in FIG. 1 as substantially cylindrical, and not included in the “variable diameter” shank portion 70, col. 4 / lines 14-16) along a longitudinal axis with reverse angle threads (left-handed threads) formed around a distal end of the body portion (col. 2 / lines 29-31), FIG. 1, and the reverse angle threads extending a length of the body portion to terminate adjacent to a proximal end of the body portion (where the screw comprises a threaded distal end and an unthreaded proximal end, where the ends comprise portions of the screw length, the threads extend the length of the body portion, along the distal end, to terminate adjacent to the unthreaded proximal end), and a drive coupling (42 and 44; where unique means unlike anything else; the drive coupling is unlike a slotted drive coupling or any coupling without both a polygonal cavity and internal threads) (col. 4 / lines 18-20, col. 6 / lines 12-27 and 45-67) formed in the proximal end of the body portion, FIGs. 1 and 4B; and a reverse thread drive mechanism (100) reciprocally configured to engage the drive coupling of the reverse thread screw (the mechanism tool is reciprocally, or inversely related, to the shape of the drive coupling because they are negatives of each other) (col. 5 / line 47 – col. 6 / line 27), FIGs. 4A-5.
Although Eisermann discloses that the screw may be comprised of radiopaque and radiolucent materials to create a marker readily observed during imaging (col. 6 / line 66 – col. 7 / line 8), Eisermann is silent as to a predefined radiographic identifier adhered to or embedded in the body portion such that the reverse thread bone screw is identifiable in situ by x-ray (claim 18).
Erickson teaches a radiolucent bone screw (col. 4 / line 62-63), in the same field of endeavor of surgical screws, comprising a predefined radiographic identifier (44, the identifier is predefined because it is defined in advance, during manufacture), FIG. 5, embedded in a body portion of the screw (along the longitudinal axis) (col. 4 / line 66 – col. 5 / line 15), such that the bone screw is identifiable in situ by x-ray (col. 1 / lines 21-44; col. 3 / line 66 – col. 4 / line 2; col. 6 / lines 4-16), wherein the predefined radiographic identifier comprises one or more beads of increased radiographic density connected to the body portion and arranged longitudinally along the body portion, FIG. 5, so that the radiolucent bone screw minimizes interference with the radiograph so that the surgical site can be better viewed while the radiographic identifiers with increased radiographic density still allow identification of the screws to ensure they are properly placed (col. 6 / lines 4-16).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to comprise Eisermann’s bone screw of a radiolucent material with a predefined radiographic identifier comprising beads of increased radiographic density embedded in the body portion and arranged longitudinally along the body portion, as taught by Erickson, so that the surgical site can be better viewed while the radiographic identifiers with increased radiographic density still allow identification of the screws to ensure they are properly placed. The radiographic identifiers allow the reverse thread bone screw of Eisermann to be identifiable in situ by x-ray, where the term identifiable means distinguishable – the bone screw of Eisermann is identifiable or distinguishable in situ by x-ray because the radiographic identifiers are visible by x-ray and the presence of the bone screw, with reverse threads as disclosed by Eisermann and known by the practitioner to have radiographic identifiers therein, can therefore be seen on the image and distinguished from its surroundings. As taught by Erickson, the beads of increased radiographic density may be embedded at ends of the body portion and arranged longitudinally to allow the surgeon to observe the length of the screw and determine when the screw is properly seated.
Eisermann is silent as to the predefined radiographic identifier indicating that the bone screw has reverse thread.
Terrill teaches a bone screw includes a radiographic identifier and that the implant is marked to indicate the type of the screw to make it easier for the surgeon to identify the correct screw to use (par. [0027]).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the radiographic identifier, incorporated in Eisermann’s screw in view of Erickson, indicate that the bone screw has reverse thread, since Terrill teaches that marking an implant to indicate the type of implant, i.e. a reverse threaded bone screw, makes it easier for the surgeon to identify the correct screw to use. Since the screw includes a radiographic identifier as modified above, this identifier can be predefined or determined in advance as associated with the reverse thread bone screw. For example, the surgeon would be informed that the screws with the radiographic identifier are those with reverse thread while other screws do not have such an identifier and/or are made of different materials, or the particular location of the identifier on the screw would indicate that that screw has reverse thread. As above, the reverse thread bone screw disclosed in Eisermann is identifiable in situ by x-ray due to the modification above to include radiographic identifiers which are visible and therefore identifiable by x-ray; because the radiographic identifier indicates that the bone screw has reverse thread due to the modification in view of Terrill (or at least that the bone screw that is identified by visible radiographic identifier has reverse thread), the fact that the bone screw has reverse thread would also be identifiable in situ by x-ray.
Although Eisermann discloses that a bone screw hole is tapped before insertion of the bone screw (col. 1 / lines 54-59), Eisermann is silent as to including in the kit a reverse thread tap configured to provide reciprocally configured threads to engage the reverse angle threads of the reverse thread screw.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include in the kit the tap for tapping the bone hole before insertion of the bone screw, since it is well known in the surgical art to include all of the instruments required for a procedure in one kit to reduce surgical time and error and so that all of the required and compatible instruments are readily available in the surgical suite. This would also reduce shipping and storage costs by keeping all of the instruments together. The tap for tapping the bone hole to receive the left-handed screw of Eisermann would be a reverse thread tap to provide compatible threads to those of the reverse thread screw so that the tapped threads would engage the screw threads.
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Eisermann in view of Erickson and Terrill (hereinafter, “Eisermann/Erickson/Terrill”), as applied to claims 1-7, 10-18, and 20-22 above, and further in view of U.S. Patent No. US 5,743,914 to Skiba.
Eisermann/Erickson/Terrill disclose the claimed invention except for wherein the fixed length of the distal end of the body portion is less than 1 inch (claim 8); and wherein the fixed length of the distal end of the body portion is less than 1/2 inch (claim 9).
Skiba teaches a lag screw, in the same field of endeavor of lag screws, that has a length of 0.25 to 8.0 inches (col. 6 / lines 34-38).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the bone screw of Eisermann/Erickson/Terrill 0.25 inches long to accommodate a fracture of a small bone, since Skiba teaches that this is the lower end of the range of possible lengths for lag screws with threaded distal ends. Then, since the fixed length of the distal end is the threaded portion of the screw in Eisermann/Erickson/Terrill which extends a fraction of the length of the screw, this fixed length would be the fraction of the length of the screw, and therefore a fraction of or less than 0.25 inches, which meets the claimed limitations of less than 1 inch and less than 1/2 inch.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Eisermann in view of Erickson and Terrill (hereinafter, “Eisermann/Erickson/Terrill”), as applied to claims 1-7, 10-18, and 20-22 above, and further in view of U.S. Patent Application Publication No. US 2006/0229133 to Lin.
Eisermann/Erickson/Terrill disclose the claimed invention except for wherein the unique drive coupling includes a 3/4 circle-shaped configuration.
Lin teaches that the shape of a drive coupling (4) may include an arc-shaped groove (40) with a 3/4 circle-shaped configuration (par. [0026]), FIG. 8, to match with a wide variety of shapes of screw driver bit.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide the portion (Eisermann, 42) of the drive coupling in Eisermann/Erickson/Terrill as a square with arc-shaped grooves at its corners with a 3/4 circle-shaped configuration, as taught by Lin, since this would match with a wide variety of shapes of screw driver bit, therefore providing flexibility to the system so that it can be used with a complementary screw driver that is available, and since Eisermann contemplates that the drive coupling can take the shape of any polygon or irregular shape (col. 6 / lines 55-59) which would allow for the configuration as taught in Lin.
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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/TRACY L KAMIKAWA/Examiner, Art Unit 3775
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