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 .
The amendment filed on November 7, 2025 has been received and considered. By this amendment, claim 9 is amended, claims 1-4, 6, 7, and 11 are cancelled, claims 20-29 are added, and claims 8-10 and 12-29 are now pending in the application.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 11/7/2025, 4/28/2026, and 6/5/2026 has/have been acknowledged and is/are being considered by the Examiner.
Claim Interpretation
Claims are to be given their broadest reasonable interpretation (“BRI’’) consistent with the Specification during examination. See In re Montgomery, 677 F.3d 1375, 1379 (Fed. Cir. 2012). As applicant is aware, an Examiner is not required to make an express on-the-record interpretation of claim construction or BRI to establish a prima facie case of anticipation. As explained in In re Jung, 637 F.3d 1356, 1362 (Fed. Cir. 2011):
As this court has repeatedly noted, “the prima facie case is merely a procedural device that enables an appropriate shift of the burden of production.” Hyatt v. Dudas, 492 F.3d 1365, 1369 (Fed. Cir. 2007) (citing In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992)). See also In re Piasecki, 745 F.2d 1468, 1472 (Fed. Cir. 1984). The Patent and Trademark Office (“PTO”) satisfies its initial burden of production by “adequately explain[ing] the shortcomings it perceives so that the applicant is properly notified and able to respond.” Hyatt, 492 F.3d at 1370. In other words, the PTO carries its procedural burden of establishing a prima facie case when its rejection satisfies 35 U.S.C. § 132, in “notify[ing] the applicant ... [by] stating the reasons for [its] rejection, or objection or requirement, together with such information and references as may be useful in judging of the propriety of continuing the prosecution of [the] application.” 35 U.S.C. § 132. That section “is violated when a rejection is so uninformative that it prevents the applicant from recognizing and seeking to counter the grounds for rejection.” Chester v. Miller, 906 F.2d 1574, 1578 (Fed. Cir. 1990).
Although the BRI standard is the proper claim construction standard, this does not mean the Examiner must make on-the-record claim constructions for each claim term when applying this standard to establish a prima facie case of anticipation. In fact, Jung refused “to impose a heightened burden on examiners beyond the notice requirement of § 132,” stating:
There has never been a requirement for an examiner to make an on-the-record claim construction of every term in every rejected claim and to explain every possible difference between the prior art and the claimed invention in order to make out a prima facie rejection. This court declines to create such a burdensome and unnecessary requirement.
Jung, 637 F.3d at 1363 (emphasis added). To the contrary, the court explained, all that is required of the office to meet its prima facie burden of production is to set forth the statutory basis of the rejection and the reference or references relied upon in a sufficiently articulate and informative manner as to meet the notice requirement of § 132. Id. In Jung, the court determined that the Examiner had put applicant on notice, stating “the [Examiner’s] specific column and line cites to the prior art reference would have put any reasonable applicant on notice of the examiner’s rejection.” Id. at 1362. Once the notice requirement has been met, the burden shifts to the applicant to rebut the prima facie case, requiring the applicant to provide specific reasons why the prior art teachings do not correspond to the claim elements. See Packard, 751 F.3d at 1312; Jung, 637 F.3d at 1364; 35 U.S.C. § 132.
MPEP § 2111 describes that the BRI standard is applicable for pending claims during patent examination. In re Smith International, Inc. addressed the issue of “[t]he correct inquiry in giving a claim term its broadest reasonable interpretation in light of the specification,” that is, how to apply this claim construction standard. 871 F.3d 1375 (Fed. Cir. 2017). As long as the Examiner sets forth the statutory basis of the rejection and the reference or references relied upon in a sufficiently articulate and informative manner by providing specific column and line cites to the prior art reference, the Examiner has met the prima facie burden of production.
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.
Claims 8, 16, 19, 25, 28, and 29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2017/213978 A1 to the Mayo Foundation for Medical Education and Research (hereinafter MAYO’978).
Regarding claim 8, MAYO’978 discloses a method of treating a tinnitus condition of a patient (e.g., title; abstract), the method comprising: drilling a recess in a cochlear promontory bone of the patient, wherein said drilling comprises creating the recess in the cochlear promontory bone without completely breaking through the cochlear promontory bone (e.g., page 3, lines 3-6); implanting an implantable system for delivering electrical pulse stimuli within the patient, wherein said implanting includes intraosseously placing an electrode within the recess (e.g., page 3, lines 6-10), wherein the implantable system is a tinnitus treatment system (e.g., title; page 3, lines 3-4).
Regarding claim 16, MAYO’978 discloses wherein the electrode is connected to a distal end of a lead that comprises a shape-memory material configured to change shape in response to being heated (e.g., page 4, lines 4-16).
Regarding claim 19, MAYO’978 discloses wherein the lead also comprises a portion of the elongate electrical conductor that is uninsulated (e.g., page 8, lines 23-31).
Regarding claim 25, MAYO’978 discloses delivering, via the electrode, electrical pulse stimuli, generated by the implantable system, to the cochlear promontory bone of the patient (“In some cases, for treating tinnitus, the target electrode location may be the bony cochlea, otic capsule, and/or promontory (e.g., endosteally and/or intraosseously).”, page 7, lines 18-20, and “electrode device 600 can deliver electrical stimuli endosteally and/or intraosseously (e.g., to the promontory) to treat tinnitus.”, page 11, lines 26-28).
Regarding claim 28, MAYO’978 discloses obtaining a microdrill 500; and drilling the recess using the microdrill (“FIG. 5 depicts a drill device 500 that can be used with a rotary driver instrument. Drill device 500 includes a shank 510, a depth limiter 520, and a working portion 530. Working portion 530 includes cutting edges that can remove tissue such as bone tissue to create a hole (e.g., such as a blind hole or through hole) in the target tissue layer (e.g., anywhere on the promontory including near or at the oval window, near or at the round window, etc.).”, page 10, lines 19-24).
Regarding claim 29, MAYO ‘978 discloses obtaining data indicative of an actual thickness of the promontory (“in some cases a patient can undergo a pre-operative imaging procedure, such as a computerized tomography (CT) scan, to determine the patient's anatomical features such as, but not limited to, promontory thickness.”, page 11, lines 3-5), wherein the action of drilling the recess includes drilling the recess to a depth based on the obtained data (“a set of drill devices 500 with depth limiter 520 at differing positions can be provided so that a particular drill device 500 can be used for a particular patient to make a hole of the proper depth for the particular patient's anatomy.”, page 10, lines 31-33).
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.
Claims 9 and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over MAYO’978 in view of Hendricks et al. (US 2011/0301677 A1, hereinafter Hendricks ‘677) and Taft et al. (US 2012/0197344 A1, hereinafter Taft’344).
Regarding claim 9, MAYO’978 discloses wherein the implanting includes applying an adhesive to anchor, to the patient's anatomy, a lead comprising an elongate electrical conductor of the implantable system, wherein at least a portion of the elongate electrical conductor is insulated (e.g., page 8, line 32 through page 9, line 6).
MAYO’978 discloses the invention substantially as claimed including use of adhesives such as bone cement to anchor the implantable lead elements to tissues such as bone or cartilage (e.g., page 9, lines 1-5), but does not expressly disclose wherein the lead includes a textured portion that is a molded portion of the insulation configured to enhance cohesion of the lead with the adhesive. In the same problem-solving area, Hendricks ‘677 teaches that it is known to include a textured portion that is a molded portion of the insulation 54 surrounding at least a portion of the elongate electrical conductor 26 (see Figure 2B and “The conductive polymer and/or the insulating sheath may be modified by exposure to oxidizing chemicals, acids, or a combination thereof to impart one or more of the following properties: wettability, permeability, porosity, adhesion, or texture. In addition or in alternative, the conductive polymer and/or the insulating sheath may be modified by exposure to a silane, a self-assembled monolayer, or a combination thereof to impart one or more of the following surface properties: wettability, permeability, porosity, adhesion, or texture.”, paragraph [0016]). Furthermore, in the same problem-solving area, Taft’344 teaches that it is known to use textures on the surface of an implant in order to augment the bond between the implant and bone via an adhesive such as cement to create a stronger bond and lead to a more successful procedural outcome (e.g., paragraph [0108]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method as taught by MAYO’978 with a textured portion that is a molded portion of the insulation, as taught by Hendricks‘677 and Taft’344, since such a modification would provide the predictable results of improving the cohesion bond between the lead and the bony recess in the cochlear promontory.
Regarding claim 12, MAYO’978 discloses wherein the electrode is at the distal end of the lead and an insulated portion of the electrode is insulated by an outer insulative layer (e.g. Figs. 2-4; page 8, lines 23-31).
Regarding claim 13, MAYO’978 discloses wherein the insulated portion of the electrode includes a proximal portion of the electrode and a distal portion of the electrode is uninsulated (e.g., as shown the electrodes are distal of the insulated proximal conductor portion of the electrode structures to meet the claim).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over MAYO’978.
Regarding claim 18, MAYO’978 discloses the invention substantially as claimed, but does not expressly disclose wherein the shape-memory material comprises Nitinol. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method as taught by MAYO’978, with nitinol since it has been the most ubiquitously well-known and utilized shape-memory alloy in the medical device industry for decades due to its shape-memory properties as well as superior biocompatibility.
Alternatively, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the method as taught by MAYO’978 with nitinol, because Applicant has not disclosed that nitinol provides an advantage, is used for a particular purpose, or solves a stated problem. The instant disclosure only briefly mentions Nitinol as one example of a shape memory material (paragraph [0046]: “ in some embodiments the portion of the electrical conductor 141 extending between the distal end of the primary insulative layer 143 and the electrode 150 can comprise or consist of a shape-memory material (e.g., Nitinol, etc.)”). One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with shape-memory distal member as taught by MAYO’978, because it provides a means for providing a curved shape and since it appears to be an arbitrary design consideration which fails to patentably distinguish over MAYO’978.Therefore, it would have been an obvious matter of design choice to modify MAYO’978 to obtain the invention as specified in the claim(s).
Allowable Subject Matter
Claims 10, 14, 15, 17, 20-24, 26, and 27 are 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.
Response to Arguments
Applicant's arguments filed November 7, 2025 have been fully considered but they are not persuasive. Regarding the previous rejection of claim 8 as being anticipated by MAYO’978, Applicant provides a re-stating of the office action’s rejection of claim 8, a re-stating of the reference from page 3, lines 3-6 cited by the office action, argues that there is no express or inherent disclosure of the claim in MAYO’978, and rewrites a portion of the claim without the word “promontory”. Applicant's arguments do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections. If Applicant’s argument is that MAYO’978 fails to disclose “wherein said drilling comprises creating the recess in the cochlear promontory bone” (the conclusion the Examiner arrives at due to Applicant’s re-writing of a portion of claim 8 without the word “promontory”), this is not found persuasive because MAYO’978 explicitly discloses in the portion provided by the Applicant that a hole is drilled in a cochlear bone of the patient without penetrating through the cochlear bode and the implanting comprises intraosseously placing electrodes within the hole. To provide additional explanation and elaboration in response to Applicant’s argument, while not changing the rejection, the Examiner respectfully submits that MAYO’978 discloses that the intraosseous placement of electrodes is within the promontory (page 1, lines 10-12) and the drilling is based on promontory thickness (page 10, lines 28-29) and, therefore, the disclosure of MAYO’978 of drilling a hole in a cochlear bone and placement of the electrode intraosseously is directed to this drilling and placement with respect to the promontory. For at least the reasons stated above, the rejection stands.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAMMIE K MARLEN whose telephone number is (571)272-1986. The examiner can normally be reached Monday through Friday from 8 am until 4 pm.
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, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796
