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 .
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Applicant is reminded that their Abstract must be in narrative form and at least 50 words in length.
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because the currently filed drawings are not black and white line drawings. Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ampuero et al. (US 8,585,743).
Regarding claim 1, Ampuero et al. disclose a bone screw comprising a body (218) having a body proximal end (see figure below), a body distal end (see figure below), and a body length extending between the body proximal end and the body distal end (figure 2); a proximal portion (214) having a proximal portion proximal end (see figure below), a proximal portion external thread (216), and a proximal portion length extending from the proximal portion proximal end to the body proximal end (see figure below), the proximal portion length being less than the body length (figures 10, see figure below); a distal tip (see figure below) having a cutting surface (the thread at the distal tip is a cutting surface, as well as the point of the tip) and extending from the body distal end; and a head extension (220) disposed on the proximal portion and having a head extension internal thread (232) threaded with the proximal portion external thread form (figured 11-12). Regarding claim 3, Ampuero et al. disclose wherein the head extension proximal end has an interrupted dome (figures 11-12). Regarding claim 18, Ampuero et al. disclose the head extension is an interrupted dome (figures 11-12).
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Claims 1-2 and 6-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Khanna et al. (US 8,343,200).
Regarding claim 1, Khanna et al. disclose a bone screw comprising a body (14/310) having a body proximal end (see figure below), a body distal end (see figure below), and a body length extending between the body proximal end and the body distal end (figure 2); a proximal portion (see figure below) having a proximal portion proximal end (see figure below), a proximal portion external thread (38/30figure 14), and a proximal portion length extending from the proximal portion proximal end to the body proximal end (see figure below), the proximal portion length being less than the body length (figures 2/3, see figure below); a distal tip (see figure below) having a cutting surface (the thread at the distal tip is a cutting surface, as well as the point of the tip) and extending from the body distal end; and a head extension (12/304) disposed on the proximal portion and having a head extension internal thread (26/figure 14) threaded with the proximal portion external thread form (figure 3). Regarding claim 2, Khanna et al. disclose the head extension has a head extension proximal end (20); wherein the head extension and the proximal portion taper from the head extension proximal end to the body proximal end (column 5, lines 51-63). Regarding claim 6, Khanna et al. disclose the proximal portion has a proximal portion external diameter (external diameter of 28); wherein the body has a body external diameter (external root diameter of 32); wherein the distal tip has a distal tip external diameter (root diameter at the distal tip); and wherein the proximal portion external diameter is greater than the body external diameter and the distal tip external diameter (figure 2/3, see figure below). Regarding claim 7, Khanna et al. disclose the body and the distal tip are a uniform piece (figures 2-3, 14). Regarding claim 8, Khanna et al. disclose the head extension defines a head extension inner diameter (diameter of 26, column 6, lines 9-11); wherein the proximal portion defines a proximal portion outer diameter (diameter of 38, column 6, lines 21-29); and wherein the head extension inner diameter is greater than the proximal portion outer diameter (figure 3). Regarding claim 9, Khanna et al. disclose the distal tip defines a distal tip outer diameter (see figure below); and wherein the head extension inner diameter is greater than the distal tip outer diameter (figures 2/3, see figure below). Regarding claim 10, Khanna et al. disclose the body defines a body outer diameter (diameter of 38); and wherein the head extension inner diameter (diameter of 26) is greater than the body outer diameter (figure 3).
Regarding claim 11, Khanna et al. disclose the head extension includes a head extension external thread (28); and wherein the head extension external thread and the proximal portion external thread form are continuous (figure 3). Regarding claim 12, Khanna et al. disclose the proximal portion is tapered from the proximal portion proximal end to the body proximal end (column 5, lines 51-63). Regarding claim 13, Khanna et al. disclose the head extension abuts the proximal portion (figure 3). Regarding claim 14, Khanna et al. disclose the head extension is a separate component from the proximal portion (figure 2). Regarding claim 15, Khanna et al. disclose the head extension is configured to be loaded proximally onto the body (figures 9-10). Regarding claim 16, Khanna et al. disclose the head extension and the proximal portion are made from the same material (column 6, lines 37-40). Regarding claim 17, Khanna et al. disclose the head extension and the proximal portion are made from different materials (column 6, lines 37-49, as the specification only states that it is “most advantageously” made of the same material and does not preclude the bone screw being made of different materials and even lists a plurality of different metals and non-metal materials the screw can be made of).
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.
Claims 4-5 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Khanna et al. (US 8,343,200) in view of Blitz (US 2020/0085477).
Regarding claim 4, Khanna et al. disclose the claimed invention except for the proximal portion proximal end is beveled.
Blitz teaches the use of a beveled head/end (34, figures 1-4). The beveling of the head allows for positioning generally parallel to and flush with an exterior surface of the bone forming part of the anatomical target site when the head is implanted during use to thereby reduce or eliminate a degree to which the head will extend beyond the exterior surface of the bone when the bone screw is implanted at an angle relative to the bone structure (¶82).
Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to have constructed the proximal portion proximal end to be beveled as taught by Blitz as the beveling of the head allows for positioning generally parallel to and flush with an exterior surface of the bone forming part of the anatomical target site when the head is implanted during use to thereby reduce or eliminate a degree to which the head will extend beyond the exterior surface of the bone when the bone screw is implanted at an angle relative to the bone structure.
Regarding claim 5, Khanna et al. disclose the head extension has a head extension distal end (see figure below), but fails to expressly teach or disclose the head extension distal end is beveled.
Blitz teaches the use of a beveled head/end (34, figures 1-4). The beveling of the head allows for positioning generally parallel to and flush with an exterior surface of the bone forming part of the anatomical target site when the head is implanted during use to thereby reduce or eliminate a degree to which the head will extend beyond the exterior surface of the bone when the bone screw is implanted at an angle relative to the bone structure (¶82).
Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to have constructed the head extension distal end to be beveled as taught by Blitz as the beveling of the head allows for positioning generally parallel to and flush with an exterior surface of the bone forming part of the anatomical target site when the head is implanted during use to thereby reduce or eliminate a degree to which the head will extend beyond the exterior surface of the bone when the bone screw is implanted at an angle relative to the bone structure.
Regarding claim 19, Khanna et al. disclose a bone screw comprising a body (14/310) having a body proximal end (see figure below), a body distal end (see figure below), and a body length extending between the body proximal end and the body distal end (figure 2); a proximal portion (see figure below) having a proximal portion proximal end (see figure below), a proximal portion external thread (38/30figure 14), and a proximal portion length extending from the proximal portion proximal end to the body proximal end (see figure below), the proximal portion length being less than the body length (figures 2/3, see figure below); a distal tip (see figure below) having a cutting surface (the thread at the distal tip is a cutting surface, as well as the point of the tip) and extending from the body distal end; and a head extension (12/304) disposed on the proximal portion and having a head extension internal thread (26/figure 14) threaded with the proximal portion external thread form (figure 3); wherein the head extension and the proximal portion taper from the head extension proximal end to the body proximal end (column 5, lines 51-63). However, Khanna et al. fail to expressly teach or disclose the proximal portion proximal end is beveled.
Blitz teaches the use of a beveled head/end (34, figures 1-4). The beveling of the head allows for positioning generally parallel to and flush with an exterior surface of the bone forming part of the anatomical target site when the head is implanted during use to thereby reduce or eliminate a degree to which the head will extend beyond the exterior surface of the bone when the bone screw is implanted at an angle relative to the bone structure (¶82).
Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to have constructed the proximal portion proximal end to be beveled as taught by Blitz as the beveling of the head allows for positioning generally parallel to and flush with an exterior surface of the bone forming part of the anatomical target site when the head is implanted during use to thereby reduce or eliminate a degree to which the head will extend beyond the exterior surface of the bone when the bone screw is implanted at an angle relative to the bone structure.
Regarding claim 20, Khanna et al. disclose a bone screw comprising a body (14/310) having a body proximal end (see figure below), a body distal end (see figure below), and a body length extending between the body proximal end and the body distal end (figure 2); a proximal portion (see figure below) having a proximal portion proximal end (see figure below), a proximal portion external thread (38/30figure 14), and a proximal portion length extending from the proximal portion proximal end to the body proximal end (see figure below), the proximal portion length being less than the body length (figures 2/3, see figure below); a distal tip (see figure below) having a cutting surface (the thread at the distal tip is a cutting surface, as well as the point of the tip) and extending from the body distal end; and a head extension (12/304) disposed on the proximal portion and having a head extension internal thread (26/figure 14) threaded with the proximal portion external thread form (figure 3); wherein the head extension and the proximal portion taper from the head extension proximal end to the body proximal end (column 5, lines 51-63) and the head extension thread and the proximal portion external thread form are continuous (figure 3). However, Khanna et al. fail to expressly teach or disclose the proximal portion proximal end is beveled.
Blitz teaches the use of a beveled head/end (34, figures 1-4). The beveling of the head allows for positioning generally parallel to and flush with an exterior surface of the bone forming part of the anatomical target site when the head is implanted during use to thereby reduce or eliminate a degree to which the head will extend beyond the exterior surface of the bone when the bone screw is implanted at an angle relative to the bone structure (¶82).
Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to have constructed the proximal portion proximal end to be beveled as taught by Blitz as the beveling of the head allows for positioning generally parallel to and flush with an exterior surface of the bone forming part of the anatomical target site when the head is implanted during use to thereby reduce or eliminate a degree to which the head will extend beyond the exterior surface of the bone when the bone screw is implanted at an angle relative to the bone structure.
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW JAMES LAWSON whose telephone number is (571)270-7375. The examiner can normally be reached Mon - Fri 6:30-3:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anita Coupe can be reached at 571-270-3614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW J LAWSON/Primary Examiner, Art Unit 3619
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