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 in the reply filed on 09/25/2025 is acknowledged. Claims 1-21 are pending.
Claims 17-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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 12-16 are 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 12 recites that the guide tool stem receiving section of the pedicle screw receives the guide tool stem of an adjacent guide tool. This recitation creates confusion as the “guide tool stem” is previously recited in claim 1. When looking to Fig. 2 of the present application, the guide tool stem receiving section )24) of pedicle screw 22 receives the guide tool stem 80. This system does not disclose or mention that element 24 also receives a second guide tool stem of an adjacent guide tool as recited in claim 12. Reference should be made back to the stem first recited in claim 1.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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, 3, 5 and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Krishna et al. (U.S. 2006/0265074 A1).
Concerning claim 1, Krishna et al. disclose a spinal anchoring element system comprising a guide tool (see below) for aligning a screw-path forming instrument for use in forming a screw-path in a vertebra for the subsequent installation of a pedicle screw, the guide tool comprising a guide tool stem (see below) and a screw-path forming instrument receiving section (see below), the guide tool stem and the screw-path forming instrument receiving section being immovable relative to one another.
[AltContent: arrow][AltContent: textbox (Channel)][AltContent: arrow][AltContent: textbox (Stem)][AltContent: arrow][AltContent: textbox (Screw Path forming Instrument Receiving section)][AltContent: textbox (Guide Tool)]
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Concerning claim 3, wherein the screw-path forming instrument receiving section comprises a channel (see above) open at opposite axial ends, the channel having a bore, wherein the bore has a longitudinal axis.
Concerning claim 5, wherein the guide tool stem is arranged to fit, in use, into a guide tool stem receiving section (see Fig. 44a, element 106) of an adjacent pedicle screw.
Concerning claim 12, as best understood, further comprising a pedicle screw (see Fig. 48a, element 124), the pedicle screw comprising a guide tool stem receiving section (122) for receiving, in use, the guide tool stem (114) of an adjacent guide tool.
Claim(s) 1, 3, 4 and 6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lindner (U.S. 2010/0331897 A1).
Concerning claim 1, Lindner discloses a spinal anchoring element system comprising a guide tool (see below) for aligning a screw-path forming instrument for use in forming a screw-path in a vertebra for the subsequent installation of a pedicle screw, the guide tool comprising a guide tool stem (see below) and a screw-path forming instrument receiving section (see below), the guide tool stem and the screw-path forming instrument receiving section being immovable relative to one another.
[AltContent: arrow][AltContent: connector][AltContent: connector][AltContent: arrow][AltContent: connector][AltContent: connector][AltContent: textbox (Cylindrical Wall)][AltContent: textbox (Slot)][AltContent: textbox (Channel)][AltContent: textbox (Screw-path forming instrument receiving section)][AltContent: textbox (Guide Tool stem)][AltContent: textbox (Guide Tool)]
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Concerning claim 3, wherein the screw-path forming instrument receiving section comprises a channel (see above) open at opposite axial ends, the channel having a bore, wherein the bore has a longitudinal axis.
Concerning claim 4, wherein the channel is defined by a cylindrical wall (see above), the wall including a slot (see above) allowing, in use, a guide wire to be inserted into the channel.
Concerning claim 6, further comprising a screw-path forming instrument (see Fig. 4, element 176) for use in forming a screw-path in a vertebra for the subsequent installation of a pedicle screw, wherein the screw-path forming instrument includes a guide tool mating section (116) for aligning the screw-path forming instrument in relation to the guide tool.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krishna et al. (U.S. 2006/0265074 A1).
Krishna et al. disclose the invention substantially as described above, specifically noting that the guide tool can be formed from any suitable material, e.g., ceramic, carbide. However, Krishna et al. do not explicitly disclose that the guide tool comprises substantially radiolucent material.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to form Krishna’s guide tool from radiolucent material since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. Forming spinal implants or tools from radiolucent materials, i.e., PEEK is beneficial because it allows doctors to get a clearer view of the surrounding tissues and spinal structure.
Allowable Subject Matter
Claims 7-11 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLEN HAMMOND whose telephone number is (571)270-3819. The examiner can normally be reached Monday-Friday 8 - 4 PM .
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo C. Robert, at 571 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ELLEN C HAMMOND/Primary Examiner, Art Unit 3773