DETAILED ACTION
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claim(s) 1 and 5-7 are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Pavlov et al. (US 20060064099).
Regarding claims 1, 5 and 9, Pavlov et al. discloses insertion of a single piece cervical joint distraction device in the form of a screw 1 having a single piece structure with a proximal portion integrally formed with a tapered distal portion (Fig. 2a) placed into interfacet space (Fig. 5) (paras [0011]-[0047]).
Pavlov et al. disclose the use of an access tool in the form of a trocar (Fig. 3 and para [0055]).
Pavlov et al. also disclose a delivery tool in the form of a screwdriver 21 that has an elongated tubular body detachably coupled to a recess in the head of screw 1 and is detached from the device once the device is delivered or inserted into the facet joint (Fig. 5 and paras [0022] and [0057])
Regarding the functional recitation “cervical joint distraction device,” implant 10a can be inserted into any facet joint at any level of the spine depending on a patient’s condition (Fig. 4 shows a facet joint).
Regarding claims 6 and 7, Pavlov et al. disclose the implant to have a tapered body so that a distal end portion has a smaller or different profile than a proximal end portion of the implant (Fig. 2a and para [0047]).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 4 and 9 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Pavlov et al. (US 20060064099) in view of Blain et al. (US 20050177240 A1).
Pavlov et al. disclose all elements of the claimed invention except for an access tool in the form of an introducer needle.
Blain et al. disclose a minimally invasive approach to the cervical spine and teach the equivalence of a trocar or needle to access the spinal facet joint that is to be treated wherein an introducer is placed over the needle followed by preparation of the articular surfaces using endoscopic instruments (para [0109]).
It would have been obvious to one of ordinary skill in the art to have utilized an access tool such as an introducer needle instead of trocar wherein so doing amounts to simple substitution of one known element for another, as taught by Blain et al., to guide insertion of the aiming wire or an introducer for a minimally invasive approach to the cervical spine.
Response to Arguments
Applicant's arguments have been fully considered but are not persuasive for the following reasons. Regarding the rejections under 35 USC 102(e) over Pavlov et al., screw 1 is interpreted to be the facet joint distraction device. The transitional phrase “comprising” does not preclude the presence of other elements, such as an anti-rotation element.
Allowable Subject Matter
Claim 3 is 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
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.
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April 3, 2026
/Anu Ramana/Primary Examiner, Art Unit 3775