Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Examiner’s Note
New claim 99 recites the limitation “wherein the image sensor is advance into the sacroiliac joint without the use of joint-distending fluids or insufflation”. Although the specific examples of joint-distending fluids and insufflation are not recited in the Specification, the Specification does state that the method may be a fluidless method (paragraph [0016, 163]). This is considered to provide adequate support for new claim 99 because the Specification treats “fluidless” broadly and does not inherently or necessarily exclude joint-distending fluids or insufflation.
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 98, 101 and 102 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.
Claims 98, 101 and 102 recite the step of using the image sensor to confirm void formation between the sacrum and the lilium prior to implant insertion. This step was not found in the originally filed application. Instead, the sensor is disclosed in a step of more accurately placing the working channel and other surgical tools into the SI joint (see for example paragraph [0225]) and/or confirming the path of the working channel (paragraph [0022]). Therefore, the step of using the sensor to confirm void formation prior to implant insertion is considered new matter.
Response to Arguments
Applicants’ arguments regarding the interpretation under 112(f) are found persuasive because the phrase “bone piercing” implies a sharp or point structure.
Allowable Subject Matter
Claims 77, 80, 82, 84-88, 91-93, 96, 97, 99 and 100 are allowed.
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.
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/TESSA M MATTHEWS/Examiner, Art Unit 3773