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 .
Status of the Claims
Claims 1-2, 5-8, and 10-16 are pending (claim set as filed on 12/24/2025).
Election/Restriction
Amended claims 1-2, 5-7, and new claims 15-16 are directed to an invention(s) that is independent or distinct from the invention originally claimed for the following reasons: as noted on page 3 of the prior office action, the originally examined claims were drawn to a product which is analyzed primarily for its discrete physical structures or materials (MPEP 2103(I)(C)). Thus, the statutory class of invention was a product that was solely and originally presented, thereby, it is considered to be an election by original presentation (MPEP 821.03). In other words, Applicant may not shift the claims to a process(es) because the analysis between a product versus a method is vastly different. Note that “the general policy of the Office is that Applicants are not permitted to shift to claim another invention after an election is made and an office action on the merits is made on the elected invention” (MPEP 819).
Group I: process of making: claims 1-2 and 5
Group II: product: claims 8 and 10-14
Group III: process of using: claims 6-7 and 15-16
Inventions of Group I (claims 1-2 and 5) and Group II (claims 8 and 10-14) are related as process of making and product made. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP 806.05(f)). In the instant case, the product as claimed can be made by another and materially different process such as in vivo cultivation or three-dimensional printing tissue engineering (see the disclosure of Forgacs as cited below).
Inventions of Group II (claims 8 and 10-14) and Group III (claims 6-7 and 15-16) are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product (MPEP 806.05(h)). In the instant case, the process for using the product can be practiced with another materially different product such as a non-artificial nerve donor grafts including xenografts, allogeneic, or autologous grafts; or the product may be used for in vitro drug model studies.
Inventions of Group I (claims 1-2 and 5) and Group III (claims 6-7 and 15-16) are directed to related processes. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants (MPEP 806.05(j)). In the instant case, the inventions as claimed have a materially different design, mode of operation, function, or effect where Group I requires cell cultivation and Group III requires an implantation treatment methodology. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Since Applicant has received an action on the merits for the originally presented invention (i.e., the product claims), this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 1-2, 5-7, and 15-16 are withdrawn from consideration as being directed to a non-elected invention (i.e., the process of making or using) (see 37 CFR 1.142(b) and MPEP 821.03).
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, Applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should Applicant traverse on the ground that the inventions are not patentably distinct, Applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the Examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 of the other invention.
Priority
This application is a 371 of PCT/JP2021/039869 filed on 10/28/2021, which has a foreign application no.: JP 2020-181354 filed on 10/29/2020.
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on 12/24/2025 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the Examiner.
Withdrawal of Rejections
The response and amendments filed on 12/24/2025 are acknowledged. Any previously applied minor objections and/or minor rejections (i.e., formal matters), not explicitly restated herein for brevity, have been withdrawn necessitated by Applicant’s formality corrections and/or amendments. For the purposes of clarity of the record, the reasons for the Examiner’s withdrawal, and/or maintaining if applicable, of the substantive or essential claim rejections are detailed directly below and/or in the Examiner’s response to arguments section.
Briefly, the previously applied §101 claim rejection as being drawn to ineligible subject matter has been withdrawn necessitated by Applicant’s amendments to include non-naturally occurring structural limitations.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
New Grounds of Rejection Necessitated by Amendment
Claim Rejections - 35 USC §102, Anticipation
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 8 and 10-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Forgacs (US 2011/0313542 A1).
Forgacs’ general disclosure relates to the field of regenerative medicine and tissue engineering, and more particularly to the production of axon-guiding grafts and the use thereof for the repair of damaged nerves (see ¶ [0003]).
Regarding claim 8 pertaining to an artificial nerve graft, Forgacs discloses that “a nerve is an enclosed, cable-like bundle of axons” and “The axons are bundled together into groups called fascicles” (see ¶ [0004]). Forgacs teaches an engineered three-dimensional structure includes living cells cohered with each other. The structure is suitably a graft that facilitates restorative axon growth when the graft is implanted between the proximal and distal stubs of a severed nerve in a living organism (see abstract & ¶ [0006]-[0011], [0024]-[0025], [0113], & Figures 2 and 5). Forgacs teaches “the multicellular body can have various sizes and shapes … the length … is suitably at least about 2 centimeters” or more (see ¶ [0068]) and further teaches “one axon-guiding graft having an outer diameter of approximately 2.5 mm and a length of 3.5 cm” (see ¶ [0084], [0126], [0129]-[0134]).
Regarding claim 10 pertaining to the axon bundles, Forgacs teaches “the axon-guiding grafts can be constructed using a first type of hetero-cellular multicellular body which has a relatively higher percentage of Schwann cells, and a second type of hetero-cellular multicellular body which has a relatively lower percentage of Schwann cells” (see ¶ [0062]-[0063] and Figures 2 and 5 which would comprise at least 2 to 6 axon bundles).
Regarding claim 11 pertaining to the tissue adhesive, Forgacs teaches “the multicellular body suitably includes one or more extracellular matrix (ECM) components or one or more derivatives of one or more ECM components in addition to the plurality of cells. For example, the multicellular bodies may contain various ECM proteins (e.g., gelatin, fibrinogen, fibrin, collagen, fibronectin, laminin, elastin, and/or proteoglycans). The ECM components or derivatives of ECM components can be added to a cell paste used to form the multicellular body … The ECM components or derivatives of ECM components may promote cohesion of the cells in the multicellular body. For example, gelatin and/or fibrinogen can suitably be added to the cell paste which is used to form the multicellular body” (see ¶ [0065], [0072]-[0073], [0094]).
Regarding claims 12-13 pertaining to the medically acceptable hollow tubular structure, Forgacs teaches a collagen conduit or with a collagen conduit filled with an axon-guiding graft engineered (see ¶ [0044]). Materials for entubulation may be synthetic or natural (e.g., collagen) (see ¶ [0048]-[0049]).
Regarding claim 14, Forgacs teaches “an axon-guiding graft for restoring nerve function by promoting regenerative axon growth through the graft when the graft is implanted in a living organism” (see ¶ [0010]-[0013], [0047]-[0051], [0121]-[0128]).
Conclusion
Claims 8 and 10-14 are rejected.
Claims 1-2, 5-7, and 15-16 are withdrawn from consideration by original presentation.
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 extension fee 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 date of this final action.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NGHI V NGUYEN whose telephone number is (571)270-3055. The examiner can normally be reached Mon-Fri: 9 - 3 pm (EST).
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/NGHI V NGUYEN/Primary Examiner, Art Unit 1653