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 Status
Claims 1-15 are pending.
Claims 4-15 are withdrawn.
Claims 1-3 are under examination.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 19th, March, 2026 has been entered.
Withdrawn Claim Objections
The objection to claim 2 due to informalities as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
Withdrawn Claim Rejections - 35 USC § 112(a)
The rejection of claims 1-3 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement due to the presence of new matter as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
New Claim Rejections - 35 USC § 112(a)
Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In the amendment filed on 19th, March, 2026, claim 1 was amended to recite the following new limitations which appear to be new matter for the reasons set forth below. By nature of their dependency on claim 1, claims 2-3 are also rejected.
A review of the originally filed specification by the Examiner did NOT find any specific basis for the recited limitations. The disclosure (including the specification, claims and sequence listing) as originally filed, does not contain a specific recitation of the limitations.
The amendments which appear to be new matter and the closest support for these amendments is reviewed below.
“wherein each of the plurality of radial compartments extends in a longitudinal direction of the liver organoid” (instant claim 1)
The closest support for this limitation is “the mixed bio-ink was discharged in the form of long fibers in a cell culture solution” (para. [0080]), “discharge in the form of long fibers in the cell culture” (para. [0084, 0086]), and “the liver organoid may be used by pulling longitudinal direction in the form of a fiber” (para. [0061]). There is also related disclosure in Figures 2(a)-2(d) and Figure Legend at para. [0024] which is copied below for reference and discloses a specific longitudinal organoid shape.
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This support is insufficient because it does not support the full breadth of plurality of radial compartments that extend in the longitudinal direction which encompasses variety and breadth of distinct shapes that are not disclosed, suggested, or contemplated by Applicant’s disclosure. The general disclosure of method steps that involve some pulling of fibers as well as the disclosure of a single specific organoid shape does not provides support for the full breadth of distinct organoid shapes that include a “plurality of radial compartments” that “extends in a longitudinal direction.”
Applicant has not provided the location of support for these amendments. When filing an amendment an applicant should show support in the original disclosure for new or amended claims. See MPEP §§ 714.02 and 2163.06 ("Applicant should ... specifically point out the support for any amendments made to the disclosure.") The claim is a new or amended claim, the support for the limitation is not apparent, and applicant has not pointed out where the limitation is supported (see MPEP 2163 (I), and therefore the limitation appears to be new matter.
As noted by MPEP 608.04(a), new matter includes not only the addition of wholly unsupported subject matter, but may also include adding specific percentages or compounds after a broader original disclosure, or even the omission of a step from a method. In the instant case one skilled in the art would NOT consider the limitations above to be explicitly, implicitly, or inherently supported by Applicant’s disclosure.
Hence, there is insufficient written descriptions support for the instantly claimed limitation of and Applicant has not shown possession of the invention.
Withdrawn Claim Rejections - 35 USC § 112 (b)
The rejection of claim 3 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
Withdrawn Claim Rejections - 35 USC § 112 (d)
The rejection of claim 3 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
Claim Rejections - 35 USC § 103
The rejection of claims 1-3 under 35 U.S.C. 103 as being unpatentable over Lee et al. (Adv Mater. 2012 Oct 9;24(39):5339-44. Epub 2012 Aug 24.; henceforth “Lee”) in view of Shepard et al. (US-20140274802-A1; henceforth “Shepard”) as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
Conclusion
No claim is allowable.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIANA N EBBINGHAUS whose telephone number is (703)756-4548. The examiner can normally be reached M-F 9:30 AM to 5:30 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Paras can be reached at (571) 272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIANA N EBBINGHAUS/Examiner, Art Unit 1632
/PETER PARAS JR/Supervisory Patent Examiner, Art Unit 1632
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