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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 20 November 2025 has been entered.
Response to Amendment
This Office Action is responsive to the amendment filed on 20 November 2025. Claims 1, 10, and 18 have been amended. Claims 1-18 currently stand pending in the application.
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 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” (see rejections under 35 U.S.C. 112 below).
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.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-18 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
As to claims 1, 10, and 18, the limitation “a body portion having a cylindrical section” is not supported by the specification as originally filed. The specification does not recite that the body portion has “a cylindrical section.” Rather, the specification recites “a substantially cylindrical body portion” (emphasis added).
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 and 10-18 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 cylindrical section (60; shown in FIG. 1 as 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.
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); and 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).
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).
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.
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 cylindrical section (60; shown in FIG. 1 as 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 cylindrical section (60; shown in FIG. 1 as 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 and 10-18 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRACY L KAMIKAWA whose telephone number is (571)270-7276. The examiner can normally be reached M-F 10:00-6:30 PM.
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/TRACY L KAMIKAWA/Examiner, Art Unit 3775