DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/21/2026 has been entered.
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 10-18 are pending (claim set as filed on 05/05/2026).
Applicant’s election of the product claims is again acknowledged. Method claims 1-2, 5-7, and 15-16 stand withdrawn.
Therefore, only product claims 8, 10-14, and 17-18 are under examination.
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.
Withdrawal of Rejections
The response and amendments filed on 05/05/2026 are acknowledged. Any previously
applied minor objections and/or minor rejections, not explicitly restated herein for brevity, have been withdrawn necessitated by Applicant’s formal corrections and/or amendments.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 essential claim rejections are detailed below in the Examiner’s response to arguments section.
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 §103, Obviousness
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, 10-14, and 17-18 are rejected under 35 U.S.C. 103 as being obvious over Fujii (US 2019/0127672 A1 - cited in the IDS filed on 04/28/2023) in view of Forgacs (US 2011/0313542 A1 – previously cited).
Fujii’s general disclosure relates to a neuron cultivation device, a neuron cultivating method, cultivated neurons, an analysis and an identification of proteins in axon bundles, and usages of cultivated neurons (see ¶ [0001]). In particular, Fujii teaches the development of bundles of axons (see abstract).
Fujii discloses “A neuron comprises a cell body and an axon with an axon terminal, as shown in FIG. 2. And, as shown in FIG. 1, axons of motoneurons are bundled in a body system, and axon terminals conjugate with plural skeletal muscle cells. Thus, it is desirable to generate a mass of cell bodies or a cell body spheroid with axons in a bundle in such a state that the cell bodies, axons and axon terminals are spatially isolated each other, as shown in FIG. 2 (c), through in vitro cultivation” (see ¶ [0055]). Fujii teaches “a device for cultivating neuron with axon, the device comprising: a cultivation plate; and a plurality of modules arranged in the cultivation plate, each of the modules including at least one of first chambers receivable of cell bodies of neurons, at least one of second chambers, and at least one of channels receivable of a bundle of axon extended from the cell bodies, the channels connecting the first chambers and the second chambers, wherein bottom ends of the first chambers, the second chambers and the channels axe closed and top ends of the first chambers and the second chambers are open” (see ¶ [0007], [0055], & Figures 3-6). Fujii teaches the width of the channel 13 is preferably 100-150 μm and the height is preferably 100-200 μm, though these measurements are not limited to these figures but can be arranged if necessary (see ¶ [0010], [0060]).
Applicant’s device (see Fig. 1) Prior art device (see Fig. 3)
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Fujii teaches by cultivating beforehand a desired sort of motoneuron integrated with an axon bundle, it is possible to accomplish a transplant of the axon bundles of motoneuron (see ¶ [0079], [0113]).
Regarding the amended claim’s limitation of “graft does not contain any cell bodies”, Fujii teaches the axon bundle is isolated from the cell bodies, “so that the bundle was confirmed as highly pure collection of axons” (see ¶ [0066], [0074]).
However, Fujii does not teach: a medically acceptable hollow tubular structure or a tissue adhesive.
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]).
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], [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]). Forgacs teaches “Another approach has been introduced as an alternative for repair of extensive nerve injuries, which relies on guiding the re-growth by entubulating the section ends using natural or artificial conduits. Entubulation techniques can bridge short nerve defects without the morbidities associated with harvesting of autologous nerve grafts, but the outcomes of the repairs differ with different conduit materials. Materials for entubulation may be synthetic or natural (e.g., collagen), or allogenic (i.e., an allograft; e.g., using decellularized human cadaveric nerve)” (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]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention of use or employ the entubulation structure (i.e., medically acceptable hollow tubular structure) and cell paste (i.e., tissue adhesive) such as taught by Forgacs for the axon bundles of Fujii. The ordinary artisan would have been motivated to do so is because Forgacs teaches an engineered structure that is suitable for graft implantation of axon bundles called a nerve fascicle. Thus, Forgacs structure allows for the encasing or entubulation to protect and bind the axon bundles together for graft transplantation. The ordinary artisan would have had a reasonable expectation of success is because both of the references in the same field of endeavor directed to nerve grafts.
Conclusion
No claims were allowed.
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: 7-3 pm (EST).
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/NGHI V NGUYEN/Primary Examiner, Art Unit 1653
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