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
Claims 1-13 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/26/2025.
Applicant’s election without traverse of Group IV in the reply filed on 08/26/2025 is acknowledged.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 14 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bao et al. (“3D microniches reveal the importance of cell size and shape”, Nature Communications, 06 December 2017).
Regarding Claim 14, Bao teaches the following:
Encapsulating cells in 3D hydrogel microniches: prism shapes with controlled geometries of the bottom plane and precisely defined volumes (page 2, Results, para 1)(a microcontainer comprising walls composed of a hydrogel)
An MeHA hydrogel lid fully sealed the wells (page 2, Results, para 1)(a hydrogel lid wherein once cells and culturing medium are loaded in the microcontainer, the hydrogel walls and lid prevent the cells from escaping)
The key to the successful design or 3D microniches is the requirement to fully encapsulate single cells within a matrix material that allows both cell adhesion and permeability of nutrients and the key components of the cell culture medium could diffuse through the MeHA hydrogel (page 2, Results, para 1)(allow air and liquid exchange with the environment)
The microcontainer used for organoid culturing in the absence of any exogenous extracellular matrix is an intended use of the device. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim (see MPEP 2114). The device of Bao would be capable of organoid culturing in the absence of any exogenous extracellular matrix and therefore meets the claim. Further, Bao does teach the device to be used for organoid culture (page 2, para 1).
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Bao et al. (“3D microniches reveal the importance of cell size and shape”, Nature Communications, 06 December 2017) in view of Paganelli et al. (US20190284535A1).
Regarding Claim 15, Bao teaches all of the limitations of Claim 14 (see above). Bao does not teach the hydrogel to be agarose, gellan, anginate or a combination thereof.
Paganelli teaches encapsulating a liver organoid with a cross-linked polymer (Abstract) and the polymer forms a hydrogel around the liver organoid (para 31). Paganelli further teaches the polymer can include…hyaluronic acid… alginate, agarose… or a mixture of different polymers (para 32).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Bao and use an alginate or agarose hydrogel as taught by Paganelli. One would have been motivated to make this modification as Paganelli teaches it to be an effective hydrogel for the use in organoid culturing. See also MPEP 2144.06.
Regarding Claim 16, Bao in view of Paganelli teaches all of the limitations of Claim 15 (see above). Bao does not explicitly teach the microcontainer to have a diameter between about 100 µm and 150 µm.
Paganelli teaches the liver organoid to have a relative diameter of about 50 and 500 µm (para 43). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to size the microcontainer of Bao to fit the size of the liver organoid as taught by Paganelli. One would have been motivated to make this modification as it would allow the accommodation of the organoid and a change in size or shape has been held prima facie obvious. See MPEP 2144.04(IV)(A).
Claims 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Bao et al. (“3D microniches reveal the importance of cell size and shape”, Nature Communications, 06 December 2017) in view of Paganelli et al. (US20190284535A1) and further in view of Yanagawa et al. (US20160361466A1).
Regarding Claim 17, Bao in view of Paganelli teaches all of the limitations of Claim 16 (see above). Bao in view of Paganelli does not explicitly teach the depth between about 100 µm and 350 µm.
Yanagawa teaches a device to generate kidney organoids (Abstract). Yanagawa further teaches the cell chamber depth to vary between 50 and 400 µm and the dimensions and overall size will vary depending upon the expected size of the organoid (para 64). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to size the microcontainer of Bao in view of Paganelli to fit the size of the organoid and have a depth of 100 µm and 350 µm as taught by Yanagawa. One would have been motivated to make this modification as it would allow the accommodation of the organoid and a change in size or shape has been held prima facie obvious. See MPEP 2144.04(IV)(A).
Regarding Claim 18, Bao in view of Paganelli and further in view of Yanagawa teaches all of the limitations of Claim 17 (see above). Bao does not explicitly teach the diameter of about 100 µm and a depth of about 200 µm.
Paganelli teaches the liver organoid to have a relative diameter of about 50 and 500 µm (para 43) and ) Yanagawa teaches the cell chamber depth to vary between 50 and 400 µm and the dimensions and overall size will vary depending upon the expected size of the organoid (para 64). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to size the microcontainer of Bao to fit the size of the liver organoid as taught by Paganelli and Yanagawa. One would have been motivated to make this modification as it would allow the accommodation of the organoid and a change in size or shape has been held prima facie obvious. See MPEP 2144.04(IV)(A).
Regarding Claim 19, Bao in view of Paganelli and further in view of Yanagawa teaches all of the limitations of Claim 18 (see above). Bao does not explicitly teach the lid to be in direct contact with the culture medium containing cells once loaded with the culture medium and cells.
Paganelli teaches the first biocompatible polymer is in physical contact with the cell of the liver organoids (para 36). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the lid be in direct contact with the culture medium containing cells as Paganelli teaches the polymer (the lid of Bao) to be in physical contact with the organoid and it would have resulted in an effective system for the growth of liver organoids as taught by Paganelli.
Further, given the culture medium containing cells is not a positively recited limitation of the claim, the device of Bao would only need to be capable of coming into direct contact with the culturing medium, and as the device of Bao would be capable of being in direct contact with the culturing medium containing cells once loaded, it would meet the claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN E LEPAGE whose telephone number is (571)270-3971. The examiner can normally be reached 8:30-5:30 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Robinson can be reached at 571-272-7129. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.E.L./Examiner, Art Unit 1796
/ELIZABETH A ROBINSON/Supervisory Patent Examiner, Art Unit 1796