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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 21, 23, 24, and 26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 21 has been amended to recite “wherein in use, the facet access body is received by the guide tube, thereby anchoring the guide tube into position to access the cervical spine.” Such a recitation constitutes new matter as the disclosure does not state that the guide tube is anchored into position. The specification states that guide tube 90 (the claimed guide tube) slides over guide tool 20 (the claimed facet access body) and is docked or stabilized at the spine (see para. 0040). “Docking” or “stabilizing” do not necessarily correlate to “anchoring” as recited in claim 21. In order to overcome this rejection, the Examiner suggests amending claim 21 to recite “wherein in use, the facet access body is received by the guide tube, thereby stabilizing the position of the guide tube to provide access to the cervical spine.” Note that “stabilizing” in the suggested amendment can be replaced with “docking” if so desired. Claims 23, 24, and 26 are rejected because they depend from claim 21.
Claims 27, 29-31, and 33 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 27 has been amended to recite “wherein the guide tube is configured to receive the facet access tool via at least one of the at least two lumens thereby anchoring the guide tube into position to access the facet joint.” Such a recitation constitutes new matter as the disclosure does not state that the guide tube is anchored into position. The specification states that guide tube 90 (the claimed guide tube) slides over guide tool 20 (the claimed facet access body) and is docked or stabilized at the spine (see para. 0040). “Docking” or “stabilizing” do not necessarily correlate to “anchoring” as recited in claim 27. In order to overcome this rejection, the Examiner suggests amending claim 27 to recite “wherein the guide tube is configured to receive the facet access tool via at least one of the at least two lumens thereby stabilizing the position of the guide tube to provide access to the facet joint.” Note that “stabilizing” in the suggested amendment can be replaced with “docking” if so desired. Claims 29-31 and 33 are rejected because they depend from claim 27.
Claims 34-38 and 40 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 34 has been amended to recite “wherein the facet access tool comprises a distal end portion extending from the first or second lumen of the guide tube thereby anchoring the guide tube into position to access the facet joint.” Such a recitation constitutes new matter as the disclosure does not state that the guide tube is anchored into position. The specification states that guide tube 90 (the claimed guide tube) slides over guide tool 20 (the claimed facet access body) and is docked or stabilized at the spine (see para. 0040). “Docking” or “stabilizing” do not necessarily correlate to “anchoring” as recited in claim 34. In order to overcome this rejection, the Examiner suggests amending claim 34 to recite “wherein the facet access tool comprises a distal end portion extending from the first or second lumen of the guide tube thereby stabilizing the position of the guide tube to provide access to the facet joint.” Note that “stabilizing” in the suggested amendment can be replaced with “docking” if so desired. Claims 35-38 and 40 are rejected because they depend from claim 34.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 34-38 and 40 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 34 has been amended to recite “wherein the facet access tool comprises a distal end portion extending from the first or second lumen of the guide tube thereby anchoring the guide tube into position to access the facet joint.” Such a recitation includes a human within the scope and is therefore unpatentable. In order to overcome this rejection, the Examiner suggests amending claim 34 to recite “wherein the facet access tool comprises a distal end portion extending from the first or second lumen of the guide tube thereby anchoring the guide tube into position to access the facet joint, when in use.” Claims 35-38 and 40 are rejected because they depend from claim 34.
Allowable Subject Matter
Claims 21, 23, 24, 26, 27, 29-31, 33-38, and 40 would be allowable if amended as suggested to overcome the 35 U.S.C. 112 and 35 U.S.C. 101 rejections set forth above.
Conclusion
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 JULIANNA N HARVEY whose telephone number is (571)270-3815. The examiner can normally be reached Mon.-Fri. 8:00am-5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached 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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/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773
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