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 drawings seem to have errors in that the reference lines and characters are not lined up properly with the screw. All the drawings need to be addressed and corrected.
Claim Objections
Claims 2-13 are objected to because of the following informalities:
Claims 2-13 each have the preamble “A bioabsorbable screw” and since the screw has already been established, it should say “The bioabsorbable screw.”
Claim 3 appears to be an unfinished sentence. It doesn’t say what the internal geometry is doing. It seems that “extending” should be changed to –extends—to make a complete sentence.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 4-5 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only and/or cannot depend from any other multiple dependent claim. See MPEP § 608.01(n). Accordingly, the claims have not been further treated on the merits.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim 10 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, 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.
Claim 10 states that the screw may be made of a non-bioabsorbable polymer, but the preamble requires the screw to be bioabsorbable, so this creates a contradiction and it is unclear on the characteristics of the claimed screw.
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) 1-5 and 8-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Contiliano et al. (US 2003/0125744; “Contiliano”).
Claim 1, Contiliano discloses a bioabsorbable screw (abstract; Figs. 1-5) able to compress two fracture fragments together (Figs. 1-4; paragraph [0002]), the screw comprising a body (Fig. 1; 12) having a threaded outer section (14), and an axial longitudinal opening (16) extending therethrough (Fig. 4), the opening comprising (i) a square internal geometry (paragraph [0019]) at an internal position within the screw corresponding to the threaded outer section (Fig. 5), the square internal geometry extending between 20% to 100% of the length of the threaded outer section of the screw (Fig. 5); and (ii) a circular internal geometry (Figs. 1-5; paragraph [0019]; 22, 122) for the remaining length of the screw (Figs. 1-5).
Claim 2, Contiliano discloses a 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 (Figs. 1-5; 16, 116; paragraphs [0018]-[0019]).
Claim 3, Contiliano discloses a 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 (Figs. 1-5; paragraph [0018]).
Claim 4, Contiliano discloses a bioabsorbable screw according to claim 1, wherein the screw has a circular opening (Figs. 1-5; 22, 122) distal from the threaded outer section (the section could be the proximal section of threads), to allow an elongated cylindrical part of the inserter/driver to extend about 0.2 mm from the circular opening of the screw (Fig. 5; note how the driver 110 extends right up next to the opening 122 or could be moved slightly away from that opening, also a smaller driver head could be inserted into the device so that it looks like Applicant’s Fig. 3).
Claim 5, Contiliano discloses a bioabsorbable screw according to claim 1, wherein the length of the screw is between 14 mm and 50 mm (paragraph [0028]).
Claim 8, Contiliano discloses a bioabsorbable screw according to claim 1, wherein the screw comprises a bioabsorbable polymer (paragraphs [0010] and [0017]).
Claim 9, Contiliano discloses a bioabsorbable screw according to claim 1, wherein the screw consists substantially of a bioabsorbable polymer (paragraphs [0010] and [0017]).
Claim 10, Contiliano discloses a bioabsorbable screw according to claim 8, wherein the bioabsorbable polymer is selected from poly(L-lactide) acid (PLLA), poly(D-lactide) acid (PDLA), polylactic acid (PLA), or a non-bioabsorbable polymer such as polyether ether ketone, or a combination of any two or more thereof (paragraphs [0024]-[0026]).
Claim 11, Contiliano discloses a bioabsorbable screw according to claim 8, wherein the screw comprises a bioabsorbable polymer and a bioactive filler (paragraph [0026]; such as hydroxyapatite).
Claim 12, Contiliano discloses a bioabsorbable screw according to claim 11, 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]).
Claim 13, Contiliano discloses a bioabsorbable screw according to claim 1, wherein the screw is a lag screw (Figs 1-5; 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) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Contiliano et al. (US 2003/0125744; “Contiliano”).
Claim 6, Contiliano discloses a bioabsorbable screw according to claim 1, wherein the screw is 7mm in diameter.
Contiliano does not disclose wherein the outer diameter of the shaft portion is between 3 mm and 7 mm.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the diameter and/or the length of the screw since it has been held that where the general conditions of a claim are disclosed in the prior art (i.e. a screw of nearly the same dimensions paragraph [0028] was used in the prior art and it is well known to modify the sizes of implants/screws to fit the patient and or surgical site), discovering the optimum or workable ranges involves only routine skill in the art. Furthermore since such a modification would have involved a mere change in the size of a component, which is typically recognized as being within the level of ordinary skill in the art.
Claim 7, Contiliano discloses a bioabsorbable screw according to claim 1.
However, it is not mentioned in the written description what the exact inner diameter is, even though based on the relationship that the screw is 7mm and looking at Fig. 5, the bore 116 would seem to be roughly in that range.
Therefore It would have been obvious to one having ordinary skill in the art at the time the invention was made to make the inner diameter of the shaft portion is between 2 mm and 6 mm, since it has been held that where the general conditions of a claim are disclosed in the prior art (i.e. a screw of nearly the same dimensions paragraph [0028] was used in the prior art and it is well known to modify the sizes of implants/screws to fit the patient and or surgical site), discovering the optimum or workable ranges involves only routine skill in the art. Furthermore since such a modification would have involved a mere change in the size of a component, which is typically recognized as being within the level of ordinary skill in the art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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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