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 December 29, 2025 has been received and considered. By this amendment, claims 1, 2, 14, 15, and 19 are amended, claims 12, 13, and 17 are cancelled, claims 21-23 are added, and claims 1-11, 14-16, and 18-23 are now pending in the application.
Note: The Power of Attorney documents submitted on 1/14/2025 and 1/21/2025 were not accepted (see Notice Regarding Power of Attorney mailed on 1/21/2025 and 1/29/2025) and, thus, there is not an active power of attorney in this application and the Examiner was unable to contact Applicant’s representative in order to overcome the rejections submitted herewith.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on October 9, 2025 has/have been acknowledged and is/are being considered by the Examiner.
Claim Objections
Claim 14 objected to because of the following informalities: the phrase “the buffer lay” in lines 2-3 should instead read “the buffer layer”. Appropriate correction is required.
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.
(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 22 and 23 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Carmena (U.S. 2021/0308462, previously cited). Regarding claim 22, Carmena discloses a neuromodulation device 200 having: a movable arm 204/206 formed of an elastomeric material (“the one or more curved members or a portion of the one or more curved members are coated with an elastomeric coating or a non-elastomeric coating”, paragraph [0100]), the movable arm configured to transition between an open configuration and a closed configuration (“the first curved member 204 and the second curved member 206 can be flexed outwardly (thereby widening the gap 214) to allow the nerve 208 to be positioned within the space between the curved members, and the curved members can be released so that the curved members wrap around the nerve.”, paragraph [0094]), the movable arm being biased towards the closed configuration (“the first curved member 204 and the second curved member 206 can be flexed outwardly (thereby widening the gap 214) to allow the nerve 208 to be positioned within the space between the curved members, and the curved members can be released so that the curved members wrap around the nerve.”, paragraph [0094]), the movable arm at least in part defining a chamber (central area between curved members 204/206 through which nerve 208 extends) and a channel 214, wherein the movable arm is configured such that a force applied by a nerve to the movable arm causes the arm to deform or move to enlarge the channel and permit atraumatic passage of the nerve through the channel, and wherein the movable arm is further configured to impart atraumatic retention force to the nerve while the nerve is positioned in the chamber and stimulated by an electrode (“A separation 320 between the first portion 302a and the 302b is present along the curved member (which may be similarly present in other curved members of the device). The implantable device can be implanted by flexing the first portion and the second portion of the curved member outwardly, thereby expanding the size of the separation and allowing the nerve or other filamentous tissue to pass through the separation and fit within the cylindrical space formed by the curved members. The first portion and the second portion of the curved member can be released, which allows the curved member to wrap around the nerve or other filamentous tissue.”, paragraph [0111]).
Regarding claim 23, it is respectfully submitted that the recitation “the force applied by the nerve to the movable arm is below a traumatic threshold” further defines something, the force applied by the nerve, that is not positively recited as part of the claimed device and, therefore fails to further define the claimed invention over that of the prior art.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Carmena (U.S. 2021/0308462, previously cited) in view of Shepherd (U.S. 2022/0054825, previously cited). Regarding claim 19, Carmena discloses a neuromodulation device 200 having: a movable arm 204/206 formed of an elastomeric material (“the one or more curved members or a portion of the one or more curved members are coated with an elastomeric coating or a non-elastomeric coating”, paragraph [0100]), the movable arm configured to transition between an open configuration and a closed configuration (“the first curved member 204 and the second curved member 206 can be flexed outwardly (thereby widening the gap 214) to allow the nerve 208 to be positioned within the space between the curved members, and the curved members can be released so that the curved members wrap around the nerve.”, paragraph [0094]), the movable arm being biased towards the closed configuration (“the first curved member 204 and the second curved member 206 can be flexed outwardly (thereby widening the gap 214) to allow the nerve 208 to be positioned within the space between the curved members, and the curved members can be released so that the curved members wrap around the nerve.”, paragraph [0094]), the movable arm at least in part defining a chamber (central area between curved members 204/206 through which nerve 208 extends) and a channel 214, the channel having a gap of less than 1 mm, the movable arm configured to allow passage of nerves through the channel for nerves having diameters of between 1 mm and 3 mm (“The diameter of the cylindrical space formed by the curved members depends on the target nerve and/or filamentous tissue that the implantable device will engage. In some embodiments, the one or more curved members of the device form a cylindrical space with a diameter of about 50 μm to about 15 mm (for example, about 50 μm to about 100 μm, about 100 μm to about 250 μm, about 250 μm to about 500 μm, about 500 μm to about 1 mm, about 1 mm to about 1.5 mm, about 1.5 mm to about 2.5 mm, about 2.5 mm to about 5 mm, about 5 mm to about 10 mm, or about 10 mm to about 15 mm).”, paragraph [0097]). However, Carmena fails to disclose providing less than 6.7 kPa of pressure to the nerve, the movable arm further configured to impart less than 4 kPa of pressure to the nerve as it is stimulated by an electrode in the chamber. Shepherd in the field of nerve cuffs (see Abstract) teaches channel walls that apply less than 6.7 kPa of pressure to the nerve at any given point (“The loop A may be shaped and configured (e.g. by material selection) to apply a pressure to the peripheral nerve 200 to reshape the nerve over time, wherein the pressure applied to the nerve is under a predetermined limit, such as approximately 30 mm Hg (approx. 4 kPa) during reshaping.”, paragraph [0100]). 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 invention of Carmena to apply less than 6.7 kPa of pressure to the nerve at any given point, as taught by Shepherd, in order to facilitate reshaping of the nerve without causing irreparable damage.
Regarding claim 20, Carmen discloses that the movable arm is configured to press against the nerve in the chamber to deform the nerve (see Figure 2A). It is respectfully submitted that the recitation “but not to reduce a cross-sectional area of the nerve more than 10%” fails to further define the claimed invention over that of the prior art because it is directed to an intended result of the use of the device rather than further limiting a patentable aspect of the device.
Allowable Subject Matter
Claims 1-11, 14-16, 18, and 21 are allowed.
Response to Arguments
Applicant fails to present any arguments specific to the rejection of claims 19 and 20 as being unpatentable over Carmena in view of Shepherd and, as such, these rejections are considered to stand as set out above.
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.
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/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796