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 .
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 1, 2 and 6 are rejected under 35 U.S.C. 102(a)(1) and (2) as being anticipated by Fisher et al. (US 9,603,538, hereinafter “Fisher”).
In regards to claim 1, Fisher discloses a system for holding at least one peripheral nerve, said system comprising:
a support surface (Fig. 1A, side facing outward from the figure for contacting a nerve, see also Fig. 12),
wherein the support surface is operational for holding the peripheral nerve (col. 1, lines 34-37, “for delivering electrical stimulation to peripheral nerves,” col. 17, line 30, “median, radial, and ulnar nerves”);
a first fastener receptacle positioned on the proximal end of the support surface (one of elements 68, see annotated Fig. 1A below, col. 9, lines 1-3, “the opening or channel 68 is configured to receive an attachment mechanism 34, such as a clip, suture, clasp, O-ring, or the like”);
a second fastener receptacle positioned on the distal end of the support surface (another of the elements 68, see annotated Fig. 1A below);
a third fastener receptacle positioned on a first side of the support surface (another of the elements 68, see annotated Fig. 1A below); and
a fourth fastener receptacle positioned on a second side of the support surface (another of the elements 68, see annotated Fig. 1A below),
wherein the first and the second side are on opposite sides of one another (see annotated Fig. 1A below), and
wherein each fastener receptacle is operational to receive at least one fastener (col. 9, lines 1-3).
PNG
media_image1.png
466
812
media_image1.png
Greyscale
Annotated Fig. 1A
In regards to claim 2, the support surface comprises a flat surface (Fig. 1A, before application to the nerve).
In regards to claim 6, the system further comprises a base area positioned below the support surface, wherein the base area is operational to stabilize the system on a surface (Fig. 1A, side facing away from the view of the figure that is capable of being placed on a surface, such as a table).
Claims 1-3 and 6 are rejected under 35 U.S.C. 102(a)(1) and (2) as being anticipated by Winograd et al. (US 2014/0107590, hereinafter “Winograd”).
In regards to claim 1, Winograd discloses a system for holding at least one peripheral nerve (Fig. 1, nerve 10/12, par. 0029), said system comprising:
a support surface (Fig. 1, inner surface of 52/54),
wherein the support surface is operational for holding the peripheral nerve (Fig. 1);
a first fastener receptacle positioned on the proximal end of the support surface (one of elements 216, see annotated Fig. 8 below, par. 0042, “Each hole 216 receives one of the tapering posts 214”);
a second fastener receptacle positioned on the distal end of the support surface (another of the elements 216, see annotated Fig. 8 below);
a third fastener receptacle positioned on a first side of the support surface (another of the elements 216, see annotated Fig. 8 below); and
a fourth fastener receptacle positioned on a second side of the support surface (another of the elements 216, see annotated Fig. 8 below),
wherein the first and the second side are on opposite sides of one another (see annotated Fig. 8 below), and
wherein each fastener receptacle is operational to receive at least one fastener (par. 0042).
PNG
media_image2.png
536
792
media_image2.png
Greyscale
Annotated Fig. 8
In regards to claim 3, wherein the system further comprises:
a first angled surface positioned on the proximal end of the support surface and behind
the first fastener receptacle; and
a second angled surface positioned on the distal end of the support surface and behind the second fastener receptacle (see annotated Fig. 8 above; angled with respect to the arbitrary proximal/distal axis).
In regards to claim 6, the system further comprises a base area positioned below the support surface, wherein the base area is operational to stabilize the system on a surface (Fig. 6, outer surface of the device is capable of being placed on a surface, such as a table).
Allowable Subject Matter
Claims 4 and 5 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 8/13/2026 have been fully considered but they are not persuasive in part and persuasive in part.
In regards to the rejection of claim 1 in view of Fisher, Applicant argued that
“[t]here is no language in Fisher or in the description of Figure 1A of Fisher that discloses a first fastener receptacle positioned on the proximal end of the support surface; a second fastener receptacle positioned on the distal end of the support surface; a third fastener receptacle positioned on a first side of the support surface; and a fourth fastener receptacle positioned on a second side of the support surface, where the first and the second side are on opposite sides of one another.
Instead, Fisher simply discloses that each of the distal end portions also includes at least one opening or channel (see element 68 of Fisher) that extends between the inner and outer surfaces of the elastic collar. That is, Fisher's openings 68 are situated exclusively on the terminal distal end portions 58 at the extreme perimeter edges of the elastic collar. Fisher's openings 68 are edge-located suture holes used to fasten the cuff closed after it wraps around a nerve. Fisher contains no disclosure or teaching of fastener receptacles positioned on the proximal end, the distal end, the first side, and the second side of the support surface, where the first and second sides are on opposite sides of one another.”
However, the examiner would like to note the extreme breadth of the geometrical object defined by the language of claim 1. No sort of frame of reference is defined for the system. In other words, the examiner’s position is that a reasonable reading of claim 1’s recitations of “proximal,” “distal,” “first side,” and “second side” are based solely on the chosen orientation of the device, with the “proximal end” being more proximal than the “distal end” and the “first side” being on an opposite side from the “second side.” Referring to Fig. 1A, reproduced and annotated above show channels 68, with two of the channels on the left side, two on the right side, two located distally, and two located proximally. There is no sort of mutual exclusivity set forth in the claim that the first (proximal) and second (distal) receptacles are not also located toward a first or second side of the system, nor that the third (first side) and fourth (second side) receptacles are not located at a proximal or distal position. With no frame of reference set forth in the claim, the examiner maintains that Fisher discloses all of the limitations of claim 1, as the system is currently recited as dependent wholly on the orientation that a viewer chooses, with Fisher meeting these limitations in Figure 1A.
In regards to claim 2 in view of Fisher, Applicant argued that Fisher fails to disclose that the channels 68 of Fisher are “slots” because “[a] hole/opening is structurally distinct from a slot (which denotes an elongated or open-ended channel/notch designed to receive and retain a sliding fastener, as shown in elements 21', 21", 23', 23", 29', 29", 31', 31" of Applicant's specification). Equating round suture holes with "slots" unreasonably expands the plain meaning of the term.” The examiner agrees, and the rejection of claim 4 in view of Fisher is withdrawn.
In regards to claim 5 in view of Fisher, Applicant argued that
“[t]here is no language in Fisher or in the description of Figures 5A, 11 and 12 of Fisher that discloses an aperture, wherein the aperture is positioned below the support surface, where the aperture spans the width of the support surface, and where the aperture is operational to receive a cord for lifting the system.
Instead, Fisher discloses that element 60 is a solid, flexible single-layer hinge/bendable sheet section of the cuff body itself. See, e.g., column 8, lines 7-29 of Fisher. Hence, element 60 is not an "aperture" (an opening, hole, or pass-through gap through a body). Furthermore, Fisher simply discusses that first and second free ends 30 and 32 can be joined together via an attachment mechanism 34, such as a clip or suture to securely wrap the elastic collar around an internal body tissue. The Examiner has not explained how such a discussion of a clip or suture to securely wrap the elastic collar around an internal body tissue relates to an aperture operational to receive a cord for lifting the system.”
Applicant’s arguments are convincing and the rejection of claim 5 in view of Fisher is withdrawn.
In regards to claim 6 in view of Fisher, Applicant argued that “[t]here is no language in Fisher or in the description of Figure 1A of Fisher that discloses a base area positioned below the support surface, where the base area is operational to stabilize the system on a surface.
Instead, Fisher simply discloses that the design of the implantable cuff allows the cuff to easily wrap into an elongated cross-section around a target body tissue. This lacks any dedicated, structural "base area" positioned below a support surface.” However, although Fisher does not discuss a “base” in the text of the disclosure, the examiner respectfully maintains that the “back side” of the system as depicted in Fig. 1A is fairly considered a “base” because it supports the other elements of the device, and is capable of stabilizing the system on a surface if it is set on said surface. If the “base” requires further structure or functionality, it is respectfully suggested to set forth those requirements in the claim limitations.
In regards to the rejection of claim 1 in view of Winograd, Applicant argued that the inner surfaces of 52 and 54 in Fig. 1 is not “operational for holding the peripheral nerve.” However, Figure 1 clearly depicts the inner surfaces of elements 52 and 54 holding peripheral nerve segments 10 and 12. It is unclear what functionality beyond containing the nerve segments would be required by “holding” the nerve, but such functionality does not appear in the claims. Applicant further argued that Winograd defines a proximal and distal direction running along the longitudinal axis of a nerve, and not as set forth in the annotated figure above. However, the claims do not. Similar to the discussion above in view of Fisher, there is no frame of reference set forth in the claim, so a similar reasoning is applied to Winograd. Applicant further argued that the connection elements of Winograd receive pins, and not a fastener such as a suture, vessel loop, or silicone strap. However, such requirements are not recited in the claim. The examiner respectfully maintains that the receptacles (such as element 228) receive pins 226, which are fairly considered “fasteners” because they fasten the two portions 52 and 54 together.
In regards to claim 2 in view of Winograd, Applicant argued that the inner surface of the cylinder tube is not flat, but instead curved. The examiner agrees and withdraws this rejection.
In regards to claim 3, Applicant argued that A 2D circular end-face curvature on a single plane cannot disclose a first angled surface positioned on the proximal end of the support surface and behind the first fastener receptacle and a second angled surface positioned on the distal end of the support surface and behind the second fastener receptacle. However, the examiner respectfully maintains the previous rejection due to the extreme breadth of this claim that merely requires a first surface on the proximal end of the support surface, behind the first receptacle and angled with respect to anything whatsoever (and a similar surface on the distal end). As set forth in the annotated figure above, the surfaces noted (as well as many others) meet the actual claim limitations set forth in claim 3.
In regards to claim 4 in view of Winograd, similar to the Fisher reference, Applicant’s comments with regards to the scope of a “slot” are convincing and the rejection is withdrawn.
In regards to claim 6 in view of Winograd, the examiner takes a similar position as with Fisher above. Although Winograd does not discuss a “base” in the text of the disclosure, the examiner respectfully maintains that the surface of the system set forth above is fairly considered a “base” because it supports the other elements of the device, and is capable of stabilizing the system on a surface if it is set on said surface. If the “base” requires further structure or functionality, it is respectfully suggested to set forth those requirements in the claim limitations.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Raspopovic et al. (US 2019/0217083) is another example of a nerve support structure.
THIS ACTION IS MADE FINAL. 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 MICHAEL W KAHELIN whose telephone number is (571)272-8688. The examiner can normally be reached M-F, 8-5.
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.
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.
/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792
Prosecution Insights