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 .
Response to Amendment
This Action is in response to the Amendment filed September 03, 2025.
In response to the Amendment, the 112 rejection as being incomplete for omitting essential elements is withdrawn, but the claims remain rejected under 35 USC 112(b) as set forth below.
Claims 7, 9, 12, and 22 are amended.
Claim 8 is canceled.
Claims 7, 9-15, and 19-22 are pending.
Response to Arguments
Applicant's arguments filed September 3, 2025 have been fully considered but they are not persuasive.
In response to Applicant’s argument that Smith fails to disclose, teach or suggest a guide tube positioned in the second lumen of a dilator tube, the Examiner disagrees. The requirements of claim 7 are a guide tube having a first lumen and a first configuration, which Applicant acknowledges in the paragraph spanning pages 14-15 of the 09/032025 Remarks, wherein a second configuration comprises a dilator tube having a second lumen, where the guide tube is capable of being positioned in the second lumen and a guidewire is positioned in the first lumen of the guide tube. Smith discloses that one set of dilators may be used to create the access corridor to the 5-1 disc where the first set of dilators are designed to be impacted through the iliac bone (e.g., column 5, lines 43-54 and column 6, lines 4-31: while two different dilator sets are described, two sets are not required for impaction and nerve monitoring). That is, the needle and the cannula 34 are positioned within one of the dilators. The needle is no longer present in the guide tube in a second configuration.
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Smith expressly states that the “inner stylet 32 may be unlocked and removed from the cannula 34 which remains in place in the pilot hole. A K-wire may then be passed through the cannula 34 and into the pilot hole” (e.g., column 5, lines 51-54). Since Applicant admits that Smith discloses a dilator set, where each dilater is a tube with an opening/lumen, an inner dilator tube of Smith can be the guide tube, while an outer dilator tube can be the dilator tube. That is one of ordinary skill in the art would have recognized viewing Fig. 8 that Smith discloses a system having a guide tube having a first lumen; and a dilator tube having a second lumen where the guide tube is positioned in the second lumen and a guidewire positioned in the first lumen.
Since the claim is a system or apparatus claim, the determination of patentability is based on the product itself (see MPEP 2113). A cannula is a tube and a dilator is a tube, Smith discloses that a tube can receive a needle to create a hole, and a tube that can receive another tube and a guidewire. Since the needle is removed from the guide tube/cannula and a K-wire or similar guide is advanced into the iliac bone via the guide tube/cannula (column 5, lines 51-54), Smith discloses the first configuration and the second configuration of the claim.
Claim Rejections - 35 USC § 112
Claims 7, 9-15 and 19-22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 7, “a needle having an awl tip” (line 7) is inferentially included and it is unclear if the applicant is positively reciting or functionally reciting the element. If the element is being functionally recited, it is suggested to use functional terms such as “adapted to be” or “for”. If the element is being positively recited, it is suggested to first state the system includes the element before it is used in a connection in the claim.
Thus, the scope of claim 7 is indefinite as it is unclear what the metes and bounds of the claim are. Claim 7 is interpreted as a system comprising a guide tube having a first lumen and a first configuration which is adapted/capable of creating a hole in the pars interarticularis for receiving an electrode. The preamble of claim 7 in considered an intended use as only a hole for receiving an electrode is recited that refers back to the preamble.
Claim 9 refers to “an insertion tool, having a third lumen, attached to the permanent anchoring device” (line 2). Thus, its recitation breathes life into the preamble reference to “implanting a permanent anchoring device for securing an electrode” (claim 1, lines 1-2). Claim 1, lines 2-3, also recites that the electrode includes a stylet channel; but, claim 9, line 4, recites “a fourth lumen of the permanent anchoring device”. Does the fourth lumen have a relationship with the stylet channel? The third configuration appears to be for inserting a lead with electrode contacts using a stylet/guidewire where the lead has a permanent anchor.
Claim 12, similar to claim 7, does not positively recite a needle having an awl tip as part of the system, but one of the many configurations of the system. However, unlike, the other configurations, the claim does not positively state that the first configuration comprises a needle … . Likewise, the recitations of the third configuration is confusing as it appears that the fourth lumen and the guidewire may be the same as the stylet channel and the stylet of the preamble in claim 1. Thus, the scope of claim 12 is indefinite.
Claims 10-11 and 13-15 and 19-22 are rejected because they depend from an indefinite claim.
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, 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.
Claims 7 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication No. 2010/0241179 to Gielen et al. (hereinafter referred to as “Gielen”) in view of US Patent No. 8,790,406 to Smith.
Regarding Claim 7, Gielen discloses a system for implanting an anchoring device for securing an electrode (see title: techniques for positioning therapy delivery elements within a spinal cord; electrodes 326; and par. 75) into a pars interarticularis, over a dorsal root ganglion (see ganglion 6; par. 64 and Fig. 36B), the electrode including a stylet channel (see channel holding stylet 521, par. 76 and Fig. 27B) and a set of distal annular electrode contacts separated by a set of distal annular insulating bands (see par. 75 and Fig. 24), and configured to stimulate the dorsal root ganglion (see par. 64). Gielen discloses creating space for the lead via laminotomy or by percutaneous needle (see par. 50) and states that the needle may be replaced with a sheath components (see par. 76). Gielen differs from the claimed system in that it does not expressly disclose the first and second configurations.
However, Smith, in a related art: systems and methods for performing spine surgery teaches a system for implanting an anchoring device for securing an electrode (see electrode 56; Fig. 9) comprising a guide tube (see cannula 34) having a first lumen (see Fig. 7); and; a first configuration wherein a needle (see inner stylet 32), having an awl tip (see tip 38), is positioned in the first lumen, and is adapted to create a hole in the pars interarticularis for receiving the electrode (see col. 5, lines 43-54) wherein a second configuration comprises: a dilator tube (see dilator 40), having a second lumen (see Fig. 8); the guide tube positioned in the second lumen; and a guidewire (see K-wire 46) positioned in the first lumen in place of the needle (see column 5, lines 51-54). It would have been obvious to one of ordinary skill in the art at the time of the invention to use Smith's system to create the pilot hole of Gielen in a first configuration and to have a second configuration comprising a dilator tube, having a second lumen where the guide tube is positioned in the second lumen and the guidewire is positioned in the first lumen. because Smith teaches it provides direct access the target nerves without damaging nerves and blood vessels along the way (see col. 4, line 60-col. 5, line 2).
With respect to Claim 9, Smith further teaches wherein a third configuration comprises: an insertion tool (see dilator 42), having a third lumen, attached to the anchoring device and positioned in the second lumen (see Fig. 8), in place of the guide tube; and the guidewire is capable of being positioned in a fourth lumen of the anchoring device (see col. 5, lines 55-col. 6, line 3). With regard to attaching a permanent anchoring device, it is the Examiner’s position that one of the dilators of Smith is capable of being attached to a permanent anchoring device of Gielen’s system in order to insert/implant the same in the patient (Gielen par. 76: internal stylet 521 is inserted with in lead 533 with its electrodes and anchoring device (e.g., par. 64).
As to Claim 10, Gielen discloses a drill (see par. 61), but does not elaborate on which lumen it is placed in. The examiner considers structurally if there are four lumens present, the prior art reads on the claims. The intended use must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Gielen et al. (PG Pub. 2010/0241179) in view of Smith (US Patent 8790406), and further in view of Kim et al. (PG Pub. 2006/0052856).
Gielen does not disclose a mechanical stop. Kim discloses a similar DRG stimulator comprising a mechanical stop (see securing ring annulus 922), at a proximal end of the insertion tool, for limiting the depth of the hole (see par. 127). It would have been obvious to one of ordinary skill in the art at the time of the invention to use such a stop because Kim teaches it prevents an electrode intended to be positioned within a DRG from piercing through a DRG (see par. 141).
Allowable Subject Matter
Claim 12 would be allowable if rewritten or amended to overcome the rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Claims 13-15 and 19-22 would be allowable if rewritten to overcome the rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include 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.
US Patent Application Publication No. 2015/0080906 to Fjorback et al. is directed to an implantable medical device where the permanent anchor device is part of the lead that has contact electrodes.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE M VOORHEES whose telephone number is (571)270-3846. The examiner can normally be reached Monday-Friday 8:30 AM to 4:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at 571 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CATHERINE M VOORHEES/Primary Examiner, Art Unit 3792
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