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 Group I claims 1-14 in the reply filed on 05/27/2026 is acknowledged.
Claims 15-32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method and system, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/27/2026.
Claim Objections
Claims 2 and 7 are objected to because of the following informalities:
Claim 2 line 2 “bottom support” is suggested to read “a bottom support” for better claim structure.
Claim 2 line 2 “constructed an arranged” is suggested to read “constructed and arranged” for better grammar.
Claim 7 line 2 “the rate” is suggested to read “the predetermined rate” for better antecedent basis.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-4 and 10-12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 line 1 recites “a slot” and is unclear if this is the same as any one of the “slots” recited in claim 1, or if this is another slot. For the purposes of examination, the Office will interpret “a slot” to mean any one of the “slots” that were previously introduced in claim 1.
Claim 3 line 2 recites “and slots” and is unclear if this is the same as the “slots” recited in claim 1, or if these are other slots. For the purposes of examination, the Office will interpret the slots in claim 3 to be different than the slots in claim 1. Claim 4 is rejected due to its dependency on claim 3.
Claims 10 and 12 recite the limitations "the first chamber half" and “the second chamber half” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. It is unclear if Applicant meant to recite the first coupler half and the second coupler half as previously introduced in claim 1, or if Applicant meant to also claim that the chamber can be divided along the longitudinal plane to define a first chamber half and a second chamber half. For the purposes of examination, the Office will interpret the claim to mean the former. Claims 11-12 are also rejected due to their dependency on claim 10.
Claim 10 line 2 recites “and slots” and is unclear if this is the same as the “slots” recited in claim 1, or if these are other slots. For the purposes of examination, the Office will interpret the slots in claim 10 to be different than the slots in claim 1. Claims 11-12 are rejected due to their dependency on claim 10.
Claim Rejections - 35 USC § 103
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 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.
Claims 1-5, 10-12, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (US PGPub 2014/0163587) in view of Agarwal et al. (US PGPub 2019/0038290), hereinafter known as “Yang” and “Agarwal,” respectively.
With regards to claim 1, Yang discloses (Figures 1-4) a system for repairing a damaged peripheral nerve (paragraphs 14-15) comprising:
a coupler 100 defining a first coupler half 110 and a second coupler half 120 divided along a longitudinal plane (figure 1) having an inner lumen 111 that is sized and arranged to receive each side of the peripheral nerve 150 at a transected location thereof, the coupler 100 including slots 112 for receiving sutures 140 that anchor each side in an abutting orientation (figure 2; paragraphs 17 and 19).
Yang is silent to a chamber adapted to surround a portion of the coupler so as to bathe the transected location in a therapeutic agent.
However, in a similar field of endeavor of nerve repair, Agarwal teaches (Figures 2A-2B) a chamber 222 adapted to surround a portion of the coupler 220 so as to bathe the transected location in a therapeutic agent (Abstract; paragraphs 30 and 48-51).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Yang to include a chamber adapted to surround a portion of the coupler so as to bathe the transected location in a therapeutic agent as taught by Agarwal for the purpose of facilitating nerve regeneration (Abstract of Agarwal).
With regards to claim 2, Yang further discloses wherein the coupler 100 includes a slot 112 (see 112(b) rejection above) and bottom support 1111 located centrally along the longitudinal plane constructed an arranged to facilitate transection of the peripheral nerve 150, the bottom support 1111 being arranged to maintain the coupler 100 free of flexure (functional limitation; paragraphs 15-18 and 25 – bottom support 1111 holds the peripheral nerve 150 and therefore is capable of facilitating transection of the peripheral nerve 150, as well as maintaining the coupler 100 free of flexure since the cover 110 can be made of biodegradable or compatible material).
With regards to claim 3, Yang further discloses wherein the first coupler half 110 and the second coupler half 120 each include interengaging, friction fit tabs 116/117 and slots 126/127 for removably securing one to the other (paragraph 25).
With regards to claim 4, Yang further discloses wherein the first coupler half 110 and the second coupler half 120 are substantially identical in size and shape (figures 1-2).
With regards to claim 5, Yang further discloses wherein the coupler 100 is constructed from at least one resorbable materials (paragraphs 18 and 21 – biodegradable polyester such as PGA).
With regards to claim 10, Yang further discloses wherein the first coupler half 110 and the second coupler half 120 (see 112(b) rejection above) each include interengaging, friction fit tabs 116/117 and slots 126/127 for removably securing one to the other (paragraph 25).
With regards to claim 11, the combination discloses the system as claimed in claim 10. The combination is silent to further comprising a lid adapted to nest within inner walls of the chamber and surround the coupler.
However, Agarwal further teaches (Figures 2A-2B) a lid 212a/212b adapted to nest within inner walls 206 of the chamber 222 and surround the coupler 220 (paragraphs 43-44 – outlets 212a/212b are formed on the outer surface 206 of the coupler 220, and as a result formed within the inner walls of the chamber 222).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Yang/Agarwal to include a lid adapted to nest within inner walls of the chamber and surround the coupler as taught by Agarwal for the purpose of allowing the agent to diffuse from the reservoirs into the interior lumen of the coupler (paragraph 43 of Agarwal).
With regards to claim 12, Yang further discloses wherein the first coupler half 110 and the second coupler half 120 (see 112(b) rejection above) are substantially identical in size and shape (figures 1-2).
With regards to claim 14, as rejected above, it would be obvious to modify the system of Yang to include the chamber as taught by Agarwal. Agarwal further discloses wherein the chamber 222 defines an internal surface that is, at least in part, a cylinder (figure 2B). Thus, when incorporating the chamber of Agarwal, the claimed limitation is considered obvious.
Claims 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Yang in view of Agarwal, and further in view of Bittner (US PGPub 2019/0090872).
With regards to claims 6-7, the combination discloses the system as claimed in claim 1. The combination is silent to further comprising, an external source of the therapeutic agent that flows to the chamber at a predetermined rate (claim 6); and further comprising, a flow controller that meters the rate (claim 7).
However, in a similar field of endeavor of nerve repair, Bittner teaches (Figure 1) an external source 56 of the therapeutic agent that flows to the chamber at a predetermined rate (paragraphs 30 and 54 – pharmaceutical agent; low pressure controller or high pressure controller); and further comprising, a flow controller that meters the rate (paragraph 54 – low pressure controller or high pressure controller).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Yang/Agarwal to include an external source of the therapeutic agent that flows to the chamber at a predetermined rate and a flow controller that meters the rate as taught by Bittner for the purpose of coordinating the actions of the external source and so that the pharmaceutical agents can contact the nerve segments for a specified contact period (paragraph 54 of Bittner).
With regards to claims 8-9, the combination discloses the system as claimed in claim 1. The combination is silent wherein the therapeutic agent is a fusogen (claim 8); and wherein the fusogen comprises at least one of PEG, chitosan, dextran sulfate, n-nonyl bromide, calcium, sodium nitrate, and H-a-7 (claim 9).
However, in a similar field of endeavor of nerve repair, Bittner teaches wherein the therapeutic agent is a fusogen (Abstract; paragraphs 51, 53, and 55-59); and wherein the fusogen comprises at least one of PEG (Abstract; paragraph 51).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Yang/Agarwal to include wherein the therapeutic agent is fusogen as taught by Bittner for the purpose of advantageously improving recovery time and nerve function (paragraph 51 of Bittner).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Yang in view of Agarwal, and further in view of Yao (US PGPub 2019/0290283).
With regards to claim 13, the combination discloses the system as claimed in claim 1. The combination is silent to further comprising, electrodes that apply predetermined electrical signals to the peripheral nerve.
However, in a similar field of endeavor of nerve repair, Yao teaches electrodes that apply predetermined electrical signals to the peripheral nerve (paragraph 34).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Yang/Agarwal to include electrodes that apply predetermined electrical signals to the peripheral nerve as taught by Yao for the purpose of acting as a therapeutic regimen for promoting unidirectional cell migration and axonal growth through a neural conduit (paragraph 34 of Yao).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMMED S ADAM whose telephone number is (571)272-8981. The examiner can normally be reached 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, Jackie Ho can be reached at 571-272-4696. 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.
/MOHAMMED S ADAM/Examiner, Art Unit 3771 06/11/2026
Prosecution Insights