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 .
Election/Restrictions
Applicant’s election without traverse of Group I (device claims 1-13) in the reply filed on March 20, 2026 is acknowledged.
Drawings
The recently submitted drawings still have issues. Figs. 7 and 8 have lines that are not pointing to the proper spots along with the reference characters not lining up with their intended lines.
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.
Claim(s) 1-4, 8-9, and 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Muhling et al. (US 5169400; “Muhling”).
Claim 1, Muhling discloses a bioabsorbable screw (Fig. 8; abstract) able to compress two fracture fragments together (Fig. 8), the screw comprising a body (1) having a threaded outer section (3), and an axial longitudinal opening (5) extending therethrough (Fig. 8), the opening comprising (i) a square internal geometry (Fig. 2; col. 3, lines 20-25) at an internal position within the screw corresponding to the threaded outer section (Figs. 2 and 8), the square internal geometry extending between 20% to 100% of the length of the threaded outer section of the screw (Figs. 2 and 8); and (ii) a circular internal geometry (Fig. 8; 9) for the remaining length of the screw, wherein the length of the screw is comprised of a non-threaded shaft portion (4) which has a circular internal cross-section (9), and a threaded portion (3) which has a square internal cross-section (Fig. 2).
Claim 2, Muhling discloses the bioabsorbable screw according to claim 1, wherein when the screw is subjected to a rotational force, the force is applied only to the threaded section of the screw via the square internal geometry of the screw (col. 3, lines 25-50).
Claim 3, Muhling discloses the bioabsorbable screw according to claim 1, wherein the square internal geometry extends between 40% to 80% of the length of the threaded outer section of the screw (Fig. 8).
Claim 4, Muhling discloses the bioabsorbable screw according to claim 1, wherein the screw has a circular opening (Fig. 8; where 9 and 10 point) distal from the threaded outer section, to allow an elongated cylindrical part of the inserter/driver to extend about 0.2 mm from the circular opening of the screw (Figs. 1 and 7-8; it should be noted that the inserter is not positively recited, so the inserter could take on any shape so as long as the screw hole can allow for the function to occur).
Claim 8, Muhling discloses the bioabsorbable screw according to claim 1, wherein the screw comprises a bioabsorbable polymer (abstract, search “resorb”).
Claim 9, Muhling discloses a bioabsorbable screw according to claim 1, wherein the screw consists substantially of a bioabsorbable polymer (abstract, search “resorb”).
Claim 13, Muhling discloses the bioabsorbable screw according to claim 1, wherein the screw is a lag screw (Fig. 8; this screw meets many characteristics of a lag screw and can perform the function as acting as a lag screw).
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) 5-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Muhling et al. (US 5169400; “Muhling”).
Claim 5, Muhling discloses the bioabsorbable screw according to claim 1.
However, Muhling does not disclose the exact sizes of the screw.
It would have been an obvious matter of design choice to make the screw between 14mm and 50mm, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the screw to be of any particular size that will work for the particular scenario, since it has been held that where the general conditions of a claim are disclosed in the prior art (i.e. a screw designed to be used on a human bone), discovering the optimum or workable ranges (i.e. diameters and lengths of the screw) involves only routine skill in the art.
Claim 6, Muhling discloses the bioabsorbable screw according to claim 1.
However, Muhling does not disclose the exact sizes of portions of the screw.
It would have been an obvious matter of design choice to make the outer diameter of the shaft portion between 3mm and 7mm, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the screw to be of any particular size that will work for the particular scenario, since it has been held that where the general conditions of a claim are disclosed in the prior art (i.e. a screw designed to be used on a human bone), discovering the optimum or workable ranges (i.e. diameters and lengths of the screw) involves only routine skill in the art.
Claim 7, Muhling discloses the bioabsorbable screw according to claim 1.
However, Muhling does not disclose the exact sizes of the screw.
It would have been an obvious matter of design choice to make the inner diameter of the shaft portion to be between 2mm and 6mm, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the screw to be of any particular size that will work for the particular scenario, since it has been held that where the general conditions of a claim are disclosed in the prior art (i.e. a screw designed to be used on a human bone), discovering the optimum or workable ranges (i.e. diameters and lengths of the screw) involves only routine skill in the art.
Claim(s) 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Muhling et al. (US 5169400; “Muhling”), in view of Contiliano et al. (US 2003/0125744; “Contiliano”).
Claim 10, Muhling discloses the bioabsorbable screw according to claim 8.
However, Muhling does not disclose the type of plastic the screw is made of.
Contiliano teaches a screw wherein the bioabsorbable polymer is selected from poly(L-lactide) acid (PLLA), poly(D-lactide) acid (PDLA), polylactic acid (PLA), or a combination of any two or more thereof (paragraphs [0024]-[0026]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to make the screw of Muhling out of the material taught by Contiliano, since these are well-known materials to make a bone screw out of (paragraphs [0024]-[0026]).
Claim 11, Muhling discloses the bioabsorbable screw according to claim 8, wherein the screw comprises a bioabsorbable polymer (abstract)
However, Muhling does not disclose the screw comprising a bioactive filler.
Contiliano teaches a screw that comprises a bioactive filler (paragraph [0026]; such as hydroxyapatite).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to include a bioactive filler, as taught by Contiliano, to the screw of Muhling, in order to help reinforce the screw (paragraph [0026]). This material is also well-known in the art to help engagement between the bone and the screw.
Claim 12, Muhling in view of Contiliano discloses the bioabsorbable screw according to claim 11, Contiliano teaches wherein the bioactive filler is selected from hydroxyapatite, beta-tricalcium phosphate, or calcium sulfate, or a combination of any two or more thereof (paragraphs [0024]-[0026]).
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on the references in how they were applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Zade Coley whose telephone number is (571)270-1931. The examiner can normally be reached M-F (9-5) PT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached at (571)272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Zade Coley/Primary Examiner, Art Unit 3775
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