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
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) 1-2, 11-13, 16-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Scheiner (US 2021/0228234).
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Regarding claims 1, 12, 16, Scheiner discloses the same invention as claimed (Figures 8A-D shown above for example), including a system comprising: a needle configured to percutaneously insert into skin and form a path for inserting a lead (Figure 8C: sheath meets limitations of needle as recited), the needle comprising: a pointed distal end for percutaneously inserting the needle for placement near a hypoglossal nerve of a patient (Paragraphs 139, 143); and an elongated body comprising an inner lumen (Figure 8C), wherein the elongated body defines one or more openings connecting an outer surface of the elongated body to the inner lumen (Figure 8C: perforations 188; however, claim language is broad enough that the open ends of sheath also read on such recited openings); and the lead configured to be disposed within the inner lumen of the elongated body (Figure 8D), the lead comprising: a shaft; and one or more electrodes disposed on the shaft (Figure 8A), configured to be placed near the hypoglossal nerve and configured to stimulate the hypoglossal nerve for treating obstructive sleep apnea (OSA) (Paragraph 144), wherein locations of the one or more electrodes on the shaft at least partially correspond to the one or more openings of the needle (Figure 8D; Paragraph 144; however, claim language is broad enough that any electrode exiting an open end of sheath would also read on such locational correspondence).
Regarding claims 2, 13, Scheiner discloses placement near the hypoglossal nerve and proximate to protrusor muscles as recited (abstract).
Regarding claim 11, Scheiner discloses a trocar as recited (Figure 8A: needle meets limitations of trocar as recited).
Further regarding claim 16 and regarding claim 17, Scheiner discloses advancing the lead as recited (Figure 10).
Regarding claims 18-19, Scheiner discloses expanding fixation members as recited (Paragraph 49).
Regarding claim 20, Scheiner discloses advancing a trocar as recited (Figure 8A: needle meets limitations of trocar as recited).
Allowable Subject Matter
Claim 3-10, 14-15 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Schugt (US 2021/0228865) shows a sheath covering fixation members.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eugene T Wu whose telephone number is (571)270-5053. The examiner can normally be reached M-F 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Niketa Patel can be reached at 571-272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Eugene T Wu/Primary Examiner, Art Unit 3796
