DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114 was filed in this application after a decision by the Patent Trial and Appeal Board, but before the filing of a Notice of Appeal to the Court of Appeals for the Federal Circuit or the commencement of a civil action. Since this application is eligible for continued examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on August 22, 2025 has been entered.
Claims 1-6, 8 and 10-15 are pending. Claim 11-15 is withdrawn. Claims 7 and 9 are canceled. A complete action on the merits of claims 1-6, 8 and 10 is as follows.
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 . 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 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.
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 of this title, 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-6 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Corbett, III et al. (hereinafter ‘Corbett’, U.S. Pat. No. 5,515,848), in view of Ek et al. (U.S. PGPub. No. 2015/0151109), and further in view of Sauer et al. (hereinafter ‘Sauer’, U.S. Pat. No. 5,431,666).
In regards to independent claim 1, Corbett discloses a neuro-monitoring dilating probe (microelectrode for placement to stimulate neurons and detect electrical neural activity) that is a combined guide pin, dilator and neuro-monitoring probe all in one instrument, the neuro-monitoring probe (a microelectrode 40 in Figs. 1-5) comprising:
a proximal end (proximal region of the conductor body 42);
an opposing distal end (distal region of the conductor body 42);
an elongated shaft spanning between the proximal and distal ends (conductor body 42),
wherein the distal end terminates in a conductive exposed tip (distal end comprising an exposed tip 54 for forming an active electrode site as best shown in Figs. 4-5) and
wherein the distal end defines a tapered section that transitions from the elongated shaft to the conductive exposed tip (conical shaped distal region 48).
However, Corbett does not disclose wherein a distal-most portion of the conductive exposed tip is spherical.
Ek teaches microelectrode comprising a distal electrode tip having a sharp or blunt or even spherical tip ([0016]). Ek further teaches that the electrode with a sharp tip is advantageous if the electrode is intended for recording neural activities while an electrode with blunt tip or spherical tip reduces erosion of the electrode tip during stimulation ([0047]). Given that Corbett discloses that the electrode is configured for both recording and stimulating (Corbett, col. 1, ln. 18-22), it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to select either a sharp tip to enhance recording of neural activities or a blunt or spherical-shaped tip to improve corrosion resistance during stimulation as doing so involves routine skilled in the art ([0047]).
However, Corbett/Ek combination does not disclose wherein the proximal end defines a notch into a longitudinal surface thereof.
Sauer teaches providing a medical device comprising an elongate body (tubular member 30 in Fig. 1-2A) having a pair of notches (locking channels 80 & 72 in Fig. 2A) along a longitudinal axis of the elongate body to cooperated with a locking assembly of a handle assembly to provide a detachable engagement between the elongate body and the handle assembly (col. 6, ln. 64-col. 7, ln. 5). Given that Corbett/Ek combination is silent as to a handle assembly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the proximal end of the elongate shaft of Corbett/Ek combination and incorporate notches at the proximal portion as taught by Sauer so that the elongate shaft is configured to be releasably coupled to a locking assembly of a handle assembly. Providing a handle assembly, whether fixedly or releasably attached, is well-known in the art and a predictable result of providing comfort to a clinician during handling of the probe would ensue (col. 6, ln. 64-col. 7, ln. 5).
In regards to claim 2-5, the elongate shaft and the tapered section of Corbett inherently provides for the claimed structural features (see Fig. 1 and 5).
In regards to claim 6, Corbett further discloses that the elongated shaft and the tapered section of the distal end are coated with a biocompatible electrically-insulating coating (the dielectric material for coating the body 42 includes polyimides, epoxies, enamel, or polymer of para-chloroxylylene such as Parylene, col. 6, ln. 28-38).
In regards to claim 10, Corbett further discloses wherein the proximal end defines an electrical connector (proximal end of the probe 44 of Fig. 1 is configured to be connected to an electric equipment).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Corbett, Ek and Sauer as applied to claim 1 above, and further in view of Wilson (U.S. PGPub. No. 2018/0193042).
In regards to claim 8, Corbett/Ek/Sauer combination discloses the invention substantially as claimed in claim 1 and discussed above.
Corbett/Ek/Sauer combination further discloses wherein the entire length of the probe is about three inches or 76.2 mm (col. 6, ln. 20-24) except for the specific length of the tapered section having a longitudinal length of 10 – 20 mm.
Wilson teaches a tapered section of a neural insertion device having a distal taper length of about 10 mm to about 30 mm ([0151]: length 346 in Fig. 7A-7C). Given that Corbett is silent as to the taper length, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the tapered section length of Corbett to arrive at the claimed length as also taught by Wilson, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Furthermore, modification of the distal taper length and the overall length of a medical device to advance into a target anatomical area depending upon the clinical needs and/or mechanical properties of the medical device during advancement into the target anatomical area involves routine skilled in the art.
Response to Arguments
Applicant’s Remarks filed on August 22, 2025 is acknowledged.
Rejection of claims 1-6 and 8-10 under 35 U.S.C. 112(a) is withdrawn in light of PTAB Decision on June 20, 2025.
Rejection of claims 1-6 and 10 under 35 U.S.C. 103 as being unpatentable over Corbett (U.S. Pat. No. 5,515,858) in view of Ek (U.S. PGPub. No. 2015/0151109) is withdrawn in view of the newly incorporated claim 9. Upon further consideration, a new ground of rejection is made in view of Sauer et al. (U.S. Pat. No. 5,431,666).
Rejection of claim 8 under 35 U.S.C. 103 as being unpatentable over Corbett in view of Ek and further in view of Wilson (U.S. PGPub. No. 2018/0193042) is withdrawn and a new ground of rejection in view of Sauer is made above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EUNHWA KIM whose telephone number is (571)270-1265. The examiner can normally be reached 9AM-5:30PM.
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/EUN HWA KIM/Primary Examiner, Art Unit 3794 9/2/2025