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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-30 in the reply filed on 7/16/2026 is acknowledged.
Claims 31-36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/16/2026.
Claims 2-8 and 12-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim.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 7/16/2026.
Applicant's election with traverse of species A in the reply filed on 7/16/2026 is acknowledged. The traversal is on the ground(s) that Boggs does not teach a common technical feature between the species thus the invention would be allowable over Boggs. Specifically, Applicant argues Boggs fails to teach the claimed “housing portion” and “resiliently biased anti-migration member”. This is not found persuasive because there is no limitation in the claim identifying the structure of said components. As such, the housing portion can be seen as a proximal end of an implant as it would attach the implant as a whole into the remaining system, thereby functioning as a housing. Although the present invention does not require the same structure, since the structure is not claimed, it is subject to broadest reasonable interpretation of the examiner. Similarly, the “resiliently biased anti-migration member” is not provided with structure in the claim. The present disclosure includes various possibilities for the structure; however, the claim does not limit to any particular embodiment. In Figure 7A, the cited “resiliently biased anti-migration member” 138 is disclosed as a coil, which is consistent with the present specification, which states “[0014] In examples, the resiliently biased anti-migration member may comprise a coil, or a plurality of coils.”
The requirement is still deemed proper and is therefore made FINAL.
Claim Objections
Claim 9 is objected to because of the following informalities:
Claim 9, line 2: “wherein the or each resiliently biased anti-migration member comprises a fin” should read “wherein the resiliently biased anti-migration member comprises a fin”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 is/are rejected under 35 U.S.C. 102(A)(1) as being anticipated by Boggs et al (US 20180104481 A1).
Regarding claim 1, Boggs discloses a neural implant system (100) for percutaneous delivery of a neural implant in a patient's tissue, the neural implant system comprising:
a neural implant (130) having a housing portion (proximal end of 130) and an elongate electrode lead (134) (Figure 1; Paragraph 0166), and
a delivery device comprising:
a handle (Paragraph 0176; 0223),
a first needle (150) fixed to the handle and having a lumen (154) adapted to receive the housing portion of the neural implant (Figure 1; Paragraph 0162),
a second needle (102) having a higher gauge than the first needle (Figure 1; Paragraph 0163; 0237), the second needle comprising a retaining portion (S+104) partially surrounding the elongate electrode lead and an open side extending at least partially along the length of the second needle (Figure 9C; Paragraph 0165; 0218), wherein the second needle is retractably mounted to the housing and retractable to deploy the electrode lead in the patient's tissue (Paragraph 0169),
wherein the electrode lead comprises a resiliently biased anti-migration member (138) comprises aligned with the retaining portion of the second needle so as to be constrained before deployment (microlead 138 is anchored to the target tissue region thus functions as a resiliently biased anti-migration member and is shaped as a coil akin to the resiliently biased member disclosed in the present application [0014]) (Figure 7A, 9C; Paragraph 0189; 0218), and wherein the resiliently biased anti-migration member is configured to move into a deployed position after retraction of the second needle (Paragraph 0166; 0189).
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.
The factual inquiries 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boggs et al (US 20180104481 A1) in view of Barker et al. (US 20150297882 A1).
Regarding claims 9-11, Boggs discloses a neural implant system of claim 1 but fails to explicitly disclose wherein the resiliently biased anti-migration member comprises a fin; wherein the fin is foldable against the neural implant; and wherein the fin is shaped to be angled towards the skin of the user when implanted.
However, Barker is directed to a neural implant and teaches a lead (106); wherein a resiliently biased anti-migration member comprises a fin (351) (Figure 3A: Paragraph 0055); wherein the fin is foldable against the neural implant (Figure 3B; Paragraph 0059); and wherein the fin is shaped to be angled towards the skin of the user when implanted (the fin is shaped triangularly and functions to anchor the lead, thus is fully capable of being angled towards the skin of the user when implanted) (Paragraph 0055).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Boggs to change the anti-migration member such that the resiliently biased anti-migration member comprises a fin; wherein the fin is foldable against the neural implant; and wherein the fin is shaped to be angled towards the skin of the user when implanted, as taught by Barker, as both references and the claimed invention are directed to neural electrodes. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Boggs with the teachings of Barker by incorporating wherein the resiliently biased anti-migration member comprises a fin; wherein the fin is foldable against the neural implant; and wherein the fin is shaped to be angled towards the skin of the user when implanted in order to ensure the lead is evenly anchored from multiple points rather than just the one microlead of Boggs to provide a more secure attachment.
Claim(s) 24-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boggs as applied to claim 1 above, and further in view of Nagaoka et al. (US 20180243551 A1).
Regarding claim 24, Boggs discloses the neural implant system of claim 1, and further discloses wherein the second needle comprises an opening (110) extending longitudinally along one side of the second needle (Figure 5; Paragraph 0180), but fails to explicitly disclose wherein the resiliently biased anti-migration member comprises a resiliently biased tine disposed on the electrode lead, and wherein a width of the resiliently biased tine is greater than a width of the opening in the second needle.
However, Nagaoka is directed to a medical lead (400) and teaches a resiliently biased anti-migration member (454) comprises a resiliently biased tine disposed on the electrode lead (406) (Figure 4E; Paragraph 0060), and the combination would result in wherein a width of the resiliently biased tine is greater than a width of the opening in the second needle (the deployed tine 454 is pushed out of slot 458 and then expanded such that the width of the expanded configuration is wider than the slot, which would carry over in the slot of Boggs to prevent the resiliently biased member from receding back into the slot. See Annotated Figure 4E.).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Boggs such that wherein the resiliently biased anti-migration member comprises a resiliently biased tine disposed on the electrode lead, as taught by Nagaoka, as the references and the claimed invention are directed to medical lead devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Boggs with the teachings of Nagaoka by incorporating wherein the resiliently biased anti-migration member comprises a resiliently biased tine disposed on the electrode lead in order to ensure a more secure attachment while anchoring the lead (Nagaoka Paragraph 0064).
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Regarding claim 25, Nagaoka further teaches wherein the resiliently biased tine has a first end attached to the electrode lead and a second end that is a free end (Figure 4E), and wherein a width of the resiliently biased tine at the second end is greater than a width of the resiliently biased tine at the first end (Annotated Figure 4E).
Regarding claim 26, Nagaoka further teaches wherein the resiliently biased tine is curved (Figure 4E).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZEHRA JAFFRI whose telephone number is (571)272-7738. The examiner can normally be reached 8 AM-5:30 PM.
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/Z.J./Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771
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