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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 27, 2026 has been entered. By this amendment, claims 1, 14, 19, 22, and 23 are amended, claim 24 is added, and claims 1-11, 14-16, and 18-23 are now pending in the application.
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 22-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Neisz et al. (U.S. 2012/0197371), herein Neisz. Regarding claim 22, Neisz discloses a neuromodulation device having: a movable arm (each side of the cuffs shown in Figures 3, 4, 13A-D, and 14A-B) formed of an elastomeric material (“the cuff 100 comprises a sheet of an elastomeric material”, paragraph [0077]), the movable arm configured to transition between an open configuration and a closed configuration (“The cuff tubular body can include a tubular body wall having a longitudinal slit therethrough allowing the cuff tubular body to open to expose the cuff tubular body interior,”, paragraph [0025]), the movable arm being biased towards the closed configuration (“in which the cuff tubular body is biased to urge the tubular body to close the slit.”, paragraph [0025]), the movable arm at least in part defining a chamber (central area between curved members shown in Figures 3, 4, 13A-D, and 14A-B) and a channel (central area between curved members shown in Figures 3, 4, 13A-D, and 14A-B), wherein the movable arm is configured such that a force applied by a nerve to the movable arm causes the arm to deform and/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 (“The hinge portion is configured to yield before the force of the cuff on the nerve exceeds about 20, 25, or 30 mm Hg, in various embodiments.”, paragraph [0024], where the description of the hinge portion being configured to yield is considered a disclosure of “a force applied by a nerve to the movable arm causes the arm to deform and/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” because it describes the force of the nerve on the movable arm causing the hinge to yield to prevent damage to the nerve caused by the nerve cuff).
Regarding claim 23, it is respectfully submitted that the recitation “the force applied by the nerve to the movable arm, which causes the arm to deform and/or move to enlarge the channel and permit atraumatic passage of the nerve through the channel, 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. Furthermore, it is respectfully submitted that the disclosure of “The hinge portion is configured to yield before the force of the cuff on the nerve exceeds about 20, 25, or 30 mm Hg, in various embodiments” is a disclosure of force below a traumatic threshold.
Regarding claim 24, Neisz discloses that the channel is configured to open and/or deform in response to the force applied by the nerve to the movable arm (“The hinge portion is configured to yield before the force of the cuff on the nerve exceeds about 20, 25, or 30 mm Hg, in various embodiments.”, paragraph [0024]).
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 Neisz (U.S. 2012/0197371). Regarding claim 19, Neisz discloses a neuromodulation device having: a movable arm (each side of the cuffs shown in Figures 3, 4, 13A-D, and 14A-B) formed of an elastomeric material (“the cuff 100 comprises a sheet of an elastomeric material”, paragraph [0077]), the movable arm configured to transition between an open configuration and a closed configuration (“The cuff tubular body can include a tubular body wall having a longitudinal slit therethrough allowing the cuff tubular body to open to expose the cuff tubular body interior,”, paragraph [0025]), the movable arm being biased towards the closed configuration (“in which the cuff tubular body is biased to urge the tubular body to close the slit.”, paragraph [0025]), the movable arm at least in part defining a chamber (central area between curved members shown in Figures 3, 4, 13A-D, and 14A-B) and a channel (central area between curved members shown in Figures 3, 4, 13A-D, and 14A-B), the chamber having an electrode 150/152/154 (“The assembly further comprises electrodes 150, which in some embodiments can be anodes 152 or cathodes 154.”, paragraph [0064]), the channel providing less than 6.7 kPa of pressure to a nerve, the movable arm further configured to provide less than 4 kPa of pressure to the nerve as the nerve is positioned in the chamber (“The degree of resistance is observed as a pressure exerted by the cuff on the object, for example a nerve, and the design of the cuff is such that this resistance will range from about 2 mm to about 30 mm Hg, when the cuff is installed.”, paragraph [0082], where 2 mm to about 30 mm Hg corresponds to 0.267 to about 4 kPa). However, while Neisz discloses that the apparatus would be appropriate for a wider range of nerve sizes (“Some embodiments of the present invention provide a cuff electrode which can be used to stimulate a wider range of nerve sizes, when compared to many other cuff electrodes.”, paragraph [0021]) because the nerve cuff can “gently adjust to the nerve size” (see paragraph [0022]), it fails to disclose the channel having a gap of less than 1 mm or the movable arm configured to allow passage of nerves through the channel for nerves having diameters of between 1 mm and 3 mm. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize the device of Neisz on nerves having diameters of between 1 mm and 3 mm, as it is disclosed as being used on a wider range of nerve sizes, and since it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device, and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). Furthermore, it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 20, Neisz discloses that the movable arm is configured to press against the nerve in the chamber (“the cuff portion is configured to provide a compressive force effective to maintain contact between the electrodes and the nerve”, paragraph [0023]). It is respectfully submitted that the recitation “to deform the nerve, 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’s arguments with respect to claims 19, 20, and 22-24 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Mrva et al. (U.S. 2006/0030919).
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, 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796
Prosecution Insights