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 Application/Election/Restrictions
Applicant’s election without traverse of Group 1 (Claims 1-8) on 5/21/2026 is acknowledged.
Claims 1-12 are pending. Claims 10-12 are currently withdrawn from further consideration pursuant to 37 CFR 1.142 (b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 1-8 are the subject of the present Official action.
Priority
Applicant’s claim for the benefit of a prior-filed application KR10-2021-0077660, KR10-2022-0071910 and CON of PCT/KR2022/008401 filed on 6/15/2021, 6/14/2022 and 6/14/2022, respectively, under 35 U.S.C 119(e) or under 35 U.S.C 120, 121 or 365(c) is acknowledged.
Accordingly, the effective priority date of the instant application is granted as 6/15/2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/14/2023, 2/3/2025 and 11/7/2025 were received. The submissions were in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements were considered by the examiner.
Claim Interpretation
Claim 2 describes the intestinal and pancreas organoid being not directly connected to the cardiac organoid. For clarity of the record, not directly connected reads on an arrangement as shown below which is taken from Fig 1 of applicant’s specification.
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Claim Rejections - 35 USC § 102
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 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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 6 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Cho et al. US 2019/0390149, published 12/26/2019 (hereinafter Cho).
Claim 1: Cho describes a multi-organoid culturing device comprising multiple interconnected culturing wells used for culturing various organoids (Cho, para 9, 49 and example 13). Cho provides embodiments wherein the organoids may be selected from the group consisting of kidney, liver, pancreas, heart (cardiac) and small intestine organoids which are cultured simultaneously in separate interconnected wells (Cho, para 18 and example 13).
Claim 6: Cho describes liver organoids which are derived from induced hepatocyte-based liver tissue (Cho, example 13 and Fig 18).
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 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.
Claims 1-3 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Cho (supra) in view of Herland et al. "Quantitative prediction of human drug pharmacokinetic responses using multiple vascularized organ chips coupled by fluid transfer." Nature biomedical engineering 4.4 (2020): 421 (hereinafter Herland).
A description of Cho can be found above. Cho does not describe an organizational arrangement wherein the intestinal, pancreas and cardiac organoid are not connected to each other. Cho does not describe a specific cross-sectional width of 10 µm to 30 µm and a height of 5 µm to 20 µm.
Claims 2: Cho states that the arrangement and disposition of the chambers are not particularly limited and considers many different configurations in consideration of culture scale or use (Cho, para 69).
Claims 3: Cho describes channels with a width of 600 µm to 1000 µm and height of 100 µm to 500 µm. As to the specific cross-sectional width of 10 µm to 30 µm and a height of 5 µm to 20 µm, it has been held that in the case where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation, when the particular parameter is recognized as a result-effective variable, see MPEP 2144.05. Cho describes the general conditions for the width and height of the channels as a result-effective variable as it impacts the flow of the medium to the wells (Cho, para 55, 60, 73-74 and 85-88). Therefore, it would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to discover an optimum or workable range for the distance through routine experimentation.
Claims 2: Herland describes a pharmacokinetic approach to model biomimetic scaling based on data generated from multiple human organ-on-a-chip microfluidic culture devices (Herland, abstract). Similar to Cho, Herland investigates numerous different organoid arrangements and passage numbers. Herland provides embodiments wherein gut (intestine) chips are separated from other organoid chips like the kidney by a liver chip and a cardiac mimetic AV reservoir (Herland, Fig 1).
It would have been prima facie obvious to one of ordinary skill in the art to arrange the interconnected multi-organoid as described by Cho well such that the intestinal, pancreas and cardiac organoid are not connected to each other as described by Herland and optimize for a specific cross-sectional width of 10 µm to 30 µm and a height of 5 µm to 20 µm as presently claimed. It would have been a matter of combining prior art elements according to known methods to yield predictable results since Cho provides motivation for different arrangement and disposition of the chambers and microchannel dimensions as these are recognized result-effective variables, see MPEP 2144.05. Furthermore, Herland shows that arrangements wherein gut (intestine) chips are separated from other organoid chips like the kidney by a liver chip and a cardiac mimetic AV reservoir are known in the art and can be used to more closely mimic the organ system of the human body (Herland, Fig 1). Thus, one would have been motivated to arrange the liver as a central node wherein the intestinal, pancreas and cardiac organoid are not connected to each other to more closely model the human circulatory system. One would have a reasonable expectation of success given that both Herland and Cho experiment with different arrangements of the chambers and microchannel dimensions as these are recognized result-effective variables.
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Cho (supra) and Herland (supra) as applied to claims 1-3 and 6 above in further view of Giobbe et al. "Extracellular matrix hydrogel derived from decellularized tissues enables endodermal organoid culture." Nature communications 10.1 (2019): 5658 (hereinafter Giobbe).
A description of Cho and Herland can be found above. Neither Cho nor Herland describe hydrogels containing decellularized liver tissue-derived extracellular matrix, decellularized intestine tissue-derived extracellular matrix, decellularized pancreas tissue-derived extracellular matrix and decellularized cardiac tissue-derived extracellular matrix.
Claims 4-5: Cho describes using hydrogels like Matrigel for culturing the organoids in a three-dimensional culture (Cho, para 75-78).
Claims 4-5: Giobbe describes the use of extracellular matrix (ECM) hydrogels derived from decellularized liver, intestine, pancreas and cardiac tissues (Giobbe, abstract). Giobbe found that these hydrogel formulations enabled the formation and growth of endoderm-derived human organoids such as gastric, hepatic, pancreatic and small intestine with high efficacy (Giobbe, discussion and Fig 1).
It would have been prima facie obvious to one of ordinary skill in the art to culture the organoids described by Cho on the hydrogels containing decellularized liver tissue-derived extracellular matrix, decellularized intestine tissue-derived extracellular matrix, decellularized pancreas tissue-derived extracellular matrix and decellularized cardiac tissue-derived extracellular matrix as described by Giobbe. It would have been a matter of combining prior art elements according to known methods to yield predictable results since Giobbe shows that these ECM containing hydrogels serve as an efficient substrate for organoid culture. One would have been motivated to use the ECM containing hydrogels described by Giobbe given that these hydrogens provide a favorable 3D environment for ex vivo culture (Giobbe, discussion). One would have a reasonable expectation of success given that these are known hydrogel materials and the addition of ECM proteins was shown to improve clustering of organoid cultures as described by Giobbe (Giobbe, discussion).
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Cho (supra), Herland (supra) and Giobbe (supra) as applied to claims 1-6 above in further view of Hyun-Jong Cho et al. "Bioengineered multicellular liver microtissues for modeling advanced hepatic fibrosis driven through non‐alcoholic fatty liver disease." Small 17.14 (2021): 2007425 (hereinafter Hyun-Jong Cho).
A description of Cho, Herland and Giobbe can be found above. The collection of cited art does not describe treating the multi-organoid model with a fatty acid at a concentration range from 100 µm to 900 µm.
Claims 7-8: Hyun-Jong Cho describes a similar liver organoid culturing system for modeling hepatic fibrosis driven through non-alcoholic fatty liver disease (Hyun-Jong Cho, abstract). Hyun-Jong Cho describes how such a liver-on-a-chip system using bioengineered liver organoids can be useful in modeling hepatic fibrosis and discover possible therapeutic treatments (Hyun-Jong Cho, intro). In the experimental section, Hyun-Jong Cho describes how to induce fibrosis using fatty acids like oleic acid and palmitic acid which are used at a concentration of 0.66 mM (660 µM) and 0.33 mM (330 µM), respectively.
It would have been prima facie obvious to one of ordinary skill in the art to treat the organoid culturing system with fatty acids as a model system for hepatic fibrosis as described by Hyun-Jong Cho using the multi-organoid model system described by Cho in view of the cited art. It would have been a matter of combining prior art elements according to known methods to yield predictable results since Hyun-Jong Cho shows that the addition of fatty acids at a concentration around 500 µM to organoid models can induce fibrosis. Thus, one would have been motivated to make this combination in order to generate hepatic fibrosis organoid models to study possible therapeutic treatments. One would have a reasonable expectation of success given that fatty acids like oleic acid and palmitic acid are commercially available and can easily be administered to microfluidic organoid systems. Accordingly, in the absence of evidence to the contrary, one of ordinary skill in the art would have considered the claimed invention to have been prima facie obvious to at the time the invention was made.
Nonstatutory Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the "right to exclude" granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Langi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717 .02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP 706.02(1)(1) - 706.02(1)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of US Patent No. US 11,725,173. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims would anticipate the instant claims if they were available as prior art.
The patented claims are drawn to an organoid culturing device comprising multiple chambers storing culture media for organoids selected from liver, intestine, pancreas and cardiac organoids which are interconnected by a plurality of channels (claims 1 and 8). The patented claims would anticipate the instantly claimed invention, which is drawn to a similar organoid culturing system comprising multiple chambers storing culture media for organoids selected from liver, intestine, pancreas and cardiac organoids which are interconnected by a plurality of channels. The claim sets are patentable indistinct therefore.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of co-pending Application No: 18/479,843 (US Patent Application Publication Number US 2024/0026268). Although the claims at issue are not identical, they are not patentably distinct from each other because the co-pending claims would anticipate the instant claims if they were available as prior art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. The co-pending claims are drawn to an aggregate cell culture comprising multiple wells storing culture media for organoids selected from liver, intestine, pancreas and cardiac organoids which are interconnected by a plurality of channels (claims 1 and 6). The co-pending claims would fully anticipate the instantly claimed invention, which is drawn to a similar organoid culturing system comprising multiple chambers storing culture media for organoids selected from liver, intestine, pancreas and cardiac organoids which are interconnected by a plurality of channels. The claim sets are patentable indistinct therefore.
Conclusion
No claims allowed.
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Alexander Nicol
Patent Examiner
Art Unit 1634
/ALEXANDER W NICOL/Examiner, Art Unit 1634
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