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 Restriction/Election
The Applicant filed Amendments to the Claims and Remarks on June 29, 2026 in response to the Examiner’s Requirement for Restriction/Election, mailed June 9, 2026.
Amendments to the Claims
At this time, claims 1-9 are pending. Claim 7 has been amended. No claims have been added or cancelled. The Applicant asserts that no new matter is added. Claim 1 is in independent form. (Remarks, pg. 4-9)
Applicant’s Election of Species
The Applicant elected “Species B, Fig. 5” further stating that “at least claims 1, 5-7 and 9 correspond to the elected species…” (Remarks, pg. 5)
Applicant’s Arguments for Traversal
The Applicant made the following arguments for traversal (labeled by the Examiner as Points I-VII):
“…the skin electrode recited in the first half of claim 7 is not mutually exclusive to the other Species, as it can be used with Species A-C.” (Remarks, pg. 7)
“…amended claim 7 corresponds to the elected Species B, and should be examined.” (Remarks, pg. 7)
“…catheter 50 is not mutually exclusive to other claims and species, such as Species B, but can be a part of the other species and claimed with them. Therefore, Species F should be eliminated. Since catheter 50 can be used with Species B, Applicant submits that claim 10 also corresponds to Species B, and should be examined.” (Remarks, pg. 7)
“…the control device of claim 5 is not a claimable feature that is mutually exclusive of the other species, but rather, can be claimed with any of them. As a result, Species G should be eliminated. Since control device 30 can be used with Species B, Applicant submits that claim 5 also corresponds to Species B, and should be examined.” (Remarks, pg. 7-8)
“…[Species H] is improper for the same reason that Species G is improper.” (Remarks, pg. 8)
“…claim 6 also corresponds to Species B, and should be examined.” (Remarks, pg. 8)
“Since Species G and H are improper, Applicant submits that the Sub-Species are also improper and rendered moot. ” (Remarks, pg. 8)
In finality, the Applicant states that they elect “Species B with traverse and [submit] that at least claims 1, 5-7 and 9 correspond to Species B.” (Remarks, pg. 8)
Applicant’s arguments with respect to Points I-VII have been fully considered and are persuasive.
However, Claims 5 and 6 are dependent on claim 4, which is drawn to a nonelected species (Species C), and therefore are not examined in this office action.
Claims 2-6 and 8 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on June 29, 2026.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 7, and 9 rejected under 35 U.S.C. 102(a)(2) as being anticipated by Nieuwoudt et al. (WO 2022/182377).
Regarding independent claim 1, Nieuwoudt discloses an injectable electrode with helical wire structure and methods for minimally invasive anchoring and removal. Nieuwoudt further discloses a medical arrangement for electrical neurostimulation, the medical arrangement comprising:
an insertion aid (dispenser 10 in Figs. 13-A to 14-B, 18-A to 18-C, 37-A to 37-E, and 43 to 45-E) with an insertion shaft ((059): “…“dispenser” means any one of a needle, cannula, catheter, tube, insert.”) that is longitudinally extended and has a proximal shaft end, a distal shaft end and a lumen longitudinally extended between the proximal shaft end and the distal shaft end (See annotated Figs. 37-A to 37-E.); and
a stimulator (helical wire structure 1; See annotated Fig. 1.) with a stimulator shaft that is longitudinally extended and has a distal stimulator end (bunching anchor 8) with at least one stimulation electrode which is configured to deliver electric current pulses ((148): “…the helical wire structure may be used to transfer energy to or from the target tissue inside the body to another location within the body…”), and which has an electrical conductor ((167): “…the helical wire structure comprises multiple stranded wires, are made of an inert conductor such as platinum or gold, and may be partially coated with inert materials such as Parylene C, Fluorinated polymers, or Silicones to form “lead” regions.”), a distal end of the electrical conductor forming the at least one stimulation electrode or is connected to the at least one stimulation electrode ((151): “…the helical wire structure may be used to supply electrical stimulation or blocking energy to neural tissue…”; See annotated Figs. 37-B to 37-E.);
wherein the medical arrangement is transferable between a first configuration and a second configuration (See annotated Figs. 37-A to 37-E.),
wherein, in the first configuration, the stimulator shaft is inserted into the lumen via the proximal shaft end of the insertion shaft and the distal stimulator end protrudes beyond the distal shaft end (See Fig. 37-A.), and
wherein, in the second configuration, the stimulator shaft is proximally pulled out of the lumen of the insertion shaft and the insertion aid and the stimulator are separated from one another (See Fig. 37-E.).
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Regarding claim 7, Nieuwoudt discloses at least one counter electrode (TENS unit 32 in Fig. 11), the at least one counter electrode being designed as a skin electrode for application to a patient's skin ((073): “Fig. 11 is a conceptual diagram of the helical wire structure electrode 1 as implanted with a bunching anchor 8 at a tissue target such as a nerve, with a second bunching anchor 8 in the subcutaneous region, which is able to receive transcutaneous transmission of electrical current from a TENS unit 32 on the skin surface.”).
Regarding claim 9, Nieuwoudt discloses a catheter configured to deliver a local anaesthetic, wherein the medical arrangement is transferable into a third configuration in which the catheter, instead of the stimulator shaft, is inserted into the lumen of the insertion aid ((066): “When the guidewire 2 is removed from the electrode, there is a hollow core 5 surrounded by the inner diameter 17 of the helix 1 which allows for liquid, gel or gas delivery/transport through the helical structure while still inside the dispenser 10”; (104): “…the delivery of liquids (saline, lidocaine, steroid, bone cement, tissue glue)… The insertion may include pushing a liquid (or liquids) quasi-simultaneously via the same dispenser that is used to inject the helical wire structure.”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Lichtenstein et al. (US 2018/0153467); and
Hochman et al. (US 2018/0296792).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY G SCHLUETER whose telephone number is (703)756-4601. The examiner can normally be reached M-F 9:00am-5:30pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl Layno can be reached at (571) 272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.G.S./Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
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