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 .
Formal matters
1. The Art Unit location of your application in the USPTO has changed. To aid in correlating any papers for this application, all further correspondence regarding this application should be directed to Art Unit 1675.
Response to Amendment
2. Claim 69 has been amended, claim 55 canceled and claim 71 added as requested in the amendment filed on February 20, 2026. Following the amendment, claims 1, 4-6, 8, 11, 13-15, 18-19, 22-24, 26-42, 45, 47, 50, 52-54, 66-67 and 69-71 are pending in the instant application.
3. Claim 1, 4-6, 8, 11, 13-15, 18-19, 22-24, 26-28, 33-36, 38-41, 47, 50, 52, 54 and 66 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention(s), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 21, and September 24, 2025.
4. Claims 29-32, 37, 42, 45, 53, 67 and 69-71 are under examination in the instant office action.
5. Any objection or rejection of record, which is not expressly repeated in this action has been overcome by Applicant’s response and withdrawn.
6. Applicant’s arguments filed on February 20, 2026 have been fully considered but found to be not persuasive for reasons set forth below. New grounds of rejection necessitated by Applicant’s amendment are set forth below as well.
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.
7. New claim 71 is 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 71 is vague and indefinite for reasons that follow. The claim recites limitation “neurons are implanted […] and are formed via forced cell aggregation by centrifuging a population of neuronal bodies,” and it is not clear and cannot be determined from the claim or the specification as filed whether the centrifugation of the cells is an active step of the method. Amending the claim to recite meaningful steps that are part of the claimed invention would overcome this ground of rejection. Similarly, the limitation “the neurons in the extracellular matrix core are encased within a hydrogel biomaterial and grown in the hydrogel prior to transplantation” fails to specifically point out whether “encasing” and “growing” are part of the active protocol of the claimed method. Moreover, because the claim uses verbs in passive voice, the order of the creating and processing of the neurons suitable for implantation is not obvious. This renders the claim indefinite.
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.
8. Claim(s) 29-32, 37, 42, 45, 53, 67, 69 and 70 stand rejected under 35 U.S.C. 103 as being unpatentable over Smith et al., the ‘153 document in view of Huang et al., for reasons of record in Paper mailed on October 23, 2025.
Applicant traverses the rejection at pp. 7-12 of the Response. Specifically, Applicant submits that, “Smith discloses a method for maintaining the pro-regenerative capacity of a distal nerve segment. […] Smith does not disclose a method for maintaining the pro-regenerative capacity of a proximal nerve segment, as claimed. In contrast to Smith, Claim 29 is directed to a method for maintaining the health or motor neurons in the spinal cord and the pro-regenerative capacity of a proximal nerve segment subsequent to a nerve injury.” Applicant further argues that, “Smith fails to teach or suggest "transplanting [...] one or more neurons into a proximal site in the proximal nerve segment," as claimed. A person of ordinary skill in the art would understand that the proximal end of the nerve injury corresponds to a site at the distal end of the proximal nerve segment, which is distinguished from a proximal site in the proximal nerve segment. In other words, Smith's disclosed primary process comprising transplanting neurons at the proximal end of a nerve injury (i.e., distal end of the proximal nerve segment) during a primary procedure) is not equivalent to transplantation at a proximal site in the proximal nerve segment, as claimed.” Applicant’s arguments have been fully considered but found to be not persuasive for reasons that follow.
The essence of the argument appears to be what constitutes “a proximal site in the proximal nerve segment.” The cited art of record, Smith reference, at [0041] and within claims 16 and 47, teaches a primary procedure for nerve lesion repair, which is implantation of neurons at the proximal end of the nerve injury. The Examiner interpreted the site of implantation at the proximal end of the nerve stump as broadly any place within the proximal part of the injured nerve as opposed to implantation at the distal part. Moreover, even if to agree with Applicant’s interpretation of the prior art citation, the instant claim 69, by broadest reasonable interpretation and consistent with the specification as filed, encompasses transplanting neurons into a proximal site in the proximal nerve segment, base claim 29, “wherein the proximal site is less than 3 cm away from the site of injury,” claim 69. Thus, claims 29 and 69 effectively place the transplantation cite at the end of proximal end of the injured nerve.
Applicant further argues that, “Smith fails to teach or suggest "maintaining the health of motor neurons in the spinal cord and the pro-regenerative capacity of a proximal nerve segment subsequent to a nerve injury," as claimed.” While this has been fully considered, the argument is not persuasive because it relates to the preamble of claim 29 only. Claim 29 is limited to an active step of transplanting the neurons into the nerve segment. As fully explained earlier, this step is fully taught by Smith.
For reasons of record fully explained earlier and reasons above, the rejection is maintained.
Conclusion
9. No claim is allowed.
10. 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 OLGA N CHERNYSHEV whose telephone number is (571)272-0870. The examiner can normally be reached 9AM to 5:30PM, Monday to Friday.
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, Jeffrey Stucker can be reached at (571)272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLGA N CHERNYSHEV/Primary Examiner, Art Unit 1675
June 23, 2026
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