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 .
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, 2, 4, 5, 6, 8, 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Miller et al. (U.S. Publication No. 2011/0054537).
Miller et al. discloses an awl-tap-dilator tool (100) used in a single step surgical technique, comprising: an elongated shaft (106) having a beveled tip (142) at a distal end (Figure 6), a drill-tap section (122) adjacent to the beveled tip (Figure 7), and a dilator section (102, the thickness increases along the length of 102 and thus can be considered a dilator section) adjacent to the drill-tap section; wherein said beveled tip is used for piercing a bone (paragraph 55) and locate an appropriate trajectory under fluoroscopy (Paragraph 59); wherein said drill-tap section is used for drilling and tapping the bone in order to form a bone opening (paragraph 50); and wherein said dilator section surrounds the elongated shaft, has a larger diameter than the elongated shaft and is used for dilating tissue around and above the bone opening (Figure 1).
Regarding claim 2, said elongated shaft further comprises a handle (138) at the proximal end of the elongated shaft and wherein said handle is used for inserting and rotating the beveled tip and drill-tap section (paragraph 55).
Regarding claim 4, said dilator section comprises markings (130) on an outer surface that are used for determining length of an implant.
Regarding claim 5, the awl-tap-dilator tool further comprising a tissue protector cannula (200) that surrounds the dilator section (the element 200 is capable of being a tissue protector cannula).
Regarding claim 6 said tissue protector cannula comprises teeth (202) at a distal end, and wherein said teeth are used for impacting the tissue protector into the bone around said bone opening (paragraph 61).
Regarding claim 8, said dilator section comprises injection molded plastic (paragraph 59, PEEK is a plastic, and it is noted that “injection molded” in this sense is a product by process. The final product is shown and thus the manner in which it is formed is given little patentable weight).
Regarding claim 9, said elongated shaft, said beveled tip, and said drill-tap section comprise stainless steel (paragraph 59).
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) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miller et al. (U.S. Publication No. 2011/0054537) in view of Assell et al. (U.S. Publication No. 2007/0066977).
Miller et al. discloses the claimed invention except for said handle comprises an arrow that functions as a directional marking indicating the beveled tip's orientation. Assell et al. teaches system for providing a protected path to a procedure site. The device has a beveled element 1188 and a handle for maintaining rotational orientation of the bevel. The handle 1051 has an arrow indicating the rotational alignment (Paragraph 138). It would have been obvious to one skilled in the art to construct the device of Miller et al. with a handle that comprises an arrow that functions as a directional marking indicating the beveled tip's orientation in view of Assell et al. to indicated the rotational alignment between two elements where one element is not visible to the eye.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miller et al. (U.S. Publication No. 2011/0054537) in view of Morgenstern Lopez (U.S. Publication No. 2014/0257296).
Miller et al. discloses the claimed invention and furthermore, regarding claims 5, Miller further discloses (in alternate to claim 5 above) the awl-tap-dilator tool further comprising a tissue protector cannula (322, although called a dilator, it can also function as a protector cannula) that surrounds the dilator section (102) (paragraph 70). The depth markings 130 on the cannula show that the depth of tip 120 past the cannula 322 (paragraph 70, Figure 19B shows that the proximal end aligns with the depth markings). Miller et al. fails to disclose the tissue protector cannula having a window at a proximal end for aligning with one of the markings of the dilator section.
Morgenstern Lopez teaches a cannula device with a gauge 440 with a transparent window through with an indicator can be seen. It would have been obvious to one skilled in the art to construct the device of Miller et al. with a window on a window at a proximal end for aligning with one of the markings of the dilator section in view of Morgenstern Lopez. The window provides an obvious substitution for gauging the depth of the dilator section in relation to the tissue protector.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miller et al. (U.S. Publication No. 2011/0054537).
Miller discloses the claimed invention except for the teeth of the tissue protector cannula comprise stainless steel and said tissue protector cannula comprises injection molded plastic. It would have been obvious to one skilled in the art to construct the device of Miller et al. with stainless steel teeth on the cannula and plastic for the body since Miller et al. discloses all the materials and combing them would have only taken routine skill in the art.
Allowable Subject Matter
Claims 12-20 are allowed.
Claim 11 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.
The following is a statement of reasons for the indication of allowable subject matter: The prior art alone or in combination fails to disclose the awl dilator tool in combination with the claimed impacting component and/or the implant inserter tool. The method associated therewith is also not disclosed
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW YANG whose telephone number is (571)272-3472. The examiner can normally be reached 9:00 - 9:00 M-F.
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/ANDREW YANG/Primary Examiner, Art Unit 3775
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