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 .
Specification
The disclosure is objected to because of the following informalities:
The specification is missing the continuing data as is required (i.e. This application is a 371 of PCT/JP2022/010012 filed 03/08/2022…).
Appropriate correction is required.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 04/16/2026 is acknowledged.
Claims 7 and 8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 04/16/2026.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2 and 3 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 2, line 2 states “when pure water is accommodated”. The term “when” renders the claim indefinite as it is unclear if the water is a required limitation of the claim. Further clarification and correction is required. For examination purposes, it is being treated as the water is accommodated in the cell accommodation part.
Regarding Claim 3, line 2 states “when human hepatocellular carcinoma-derived cells”. As above, the term “when” renders the claim indefinite as it is unclear if the cells are a required limitation of the claim. Further clarification and correction is required. For examination purposes it is being as the cells are accommodated in each of the cell accommodation parts.
Claim Rejections - 35 USC § 102/103
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.
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.
1. Claims 1 and 4-6 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Tsukada et al. (WO2017057126A1) or, in the alternative, under 35 U.S.C. 103 as obvious over Tsukada et al. (WO2017057126A1) in view of Tanaka (JP2009050194A).
Regarding Claim 1, Tsukada teaches the following:
A culture vessel with a plurality of culture spaces capable of containing one cell aggregate and a culture medium (a cell accommodation part which accommodates cell and a liquid culture medium to perform cell culture)(page 8, para 2)
The material of the culture vessel is resin (page 28, para 2)
At least the inner surface bottom portion of each well portion is treated to reduce cell adhesion, such as a hydrophilization treatment including coating a layer of a water-soluble resin and forming a coating layer using a hydrophilic resin (a coating layer made of a water-soluble resin having a hydrophilic functional group at a side chain is formed on an inner surface of the cell accommodation part)(page 24-25).
Water-soluble resin solution was prepared by dissolving a polyvinyl alcohol having an azide group in its side chain… in a light-shielding polypropylene container colored with brown pigment in a 25 vol% ethanol aqueous solution. The water-soluble resin solution was added to 50 μL per well of a plasma-treated 24-well multi-well plate with a cylindrical body, and after standing for 1 minute, the plate was turned over and the excess solution was discarded. Next, after primary drying at 40°C for 60 minutes, the water-soluble resin was cured (process of cross-linking) by irradiating it with 250 nm UV light from a UV lamp at 1.0 mW/cm¹ for 30 seconds (cross-linking is formed in the water-soluble resin itself and between the water-soluble resin and the inner surface of the cell accommodation part)
Tsukada further teaches the multiwell plate irradiated with gamma rays at an absorbed dose of 10 kGy (page 50).
In view of the above, Tsukada anticipates the claimed invention because the limitation of the container subjected to a radiation sterilization treatment with an absorbed radiation dose of 20-45 kGy is a process limitation and the patentability of a product does not depend on its method of production and the final product of Tsukada is a sterilized container. See MPEP 2113.
In the alternative, Tanaka teaches a culture container having wells for forming an culturing cell aggregates (para 16). Tanaka further teaches the absorbed radiation dose is preferably 1 kGy to 50 kGy.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to treat the device of Tsukada with the absorbed radiation dose of 20-45 kGy. One would have been motivated to make this modification as Tanaka teaches it to be an acceptable range to impart sterilization properties while fully maintaining the characteristics of the container (para 37).
Regarding Claim 4, Tsukada or Tsukada in view of Tanaka teach all of the limitations of Claim 1
(see above). Tsukada further teaches water-soluble resin solution was prepared by dissolving a polyvinyl alcohol having an azide group in its side chain… having an alkyl group having carbonyl and amine… in a light-shielding polypropylene container colored with brown pigment in a 25 vol% ethanol aqueous solution. The water-soluble resin solution was added to 50 μL per well of a plasma-treated 24-well multi-well plate with a cylindrical body, and after standing for 1 minute, the plate was turned over and the excess solution was discarded. Next, after primary drying at 40°C for 60 minutes, the water-soluble resin was cured (process of cross-linking) by irradiating it with 250 nm UV light from a UV lamp at 1.0 mW/cm¹ for 30 seconds (the water-soluble resin forming the coating layer has a side chain including an aromatic azide group and a side chain including a carbonyl group, a carbonyl group is formed in the inner surface of the cell accommodation part, and cross-linking is formed between the aromatic azide group of the water-soluble resin and the carbonyl group of the water-soluble resin and between the aromatic azide group of the water-soluble resin and the carbonyl group in the inner surface of the cell accommodation part).
Regarding Claim 5, Tsukada or Tsukada in view of Tanaka teach all of the limitations of Claim 1 (see above). Tsukada further teaches the water soluble resin preferred is represented by formula (Ib)(below).
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Regarding Claim 6, Tsukada or Tsukada in view of Tanaka teach all of the limitations of Claim 1 (see above). Tsukada further teaches the culture vessel (sterile container for cell culture) comprises a multi-well plate body including a plurality of wells (cell accommodation part)(page 29).
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.
2. Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Tsukada et al. (WO2017057126A1) or Tsukada et al. (WO2017057126A1) in view of Tanaka (JP2009050194A) as applied to claim 1 above and further in view of Yakabe et al. (WO2019189356A1).
Tsukada in view of Tanaka teach all of the limitations of Claim 1 (see above). Tsukada in view of Tanaka does not explicitly teach pure water is accommodated in the cell accommodation part to be 0.12 mL/cm2, heating is carried out at 37°C for 72 hours, and an obtained test solution is placed in a cell with a layer length of 1 cm, an absorbance measured by irradiation with UV light at a wavelength of 220 nm and an absorbance measured by irradiation with UV light at a wavelength of 241 nm are both 0.10 or less.
Yakabe teaches a plastic product used in biochemistry such as regenerative medicine (para 5). Yakabe further teaches the plastic product is incubated with ultrapure water at 37°C for 72 hours the ultrapure water is recovered as the eluent (test solution)(para 6). Further, the absorbances measured at
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wavelengths 220 nm and 240 nm are .10 or less (see Table 1, below).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to create the device of Tsukada in view of Tanaka with the properties as taught by Yakabe. One would have been motivated to make these selections as Yakabe teaches the plastic product can be used for regenerative medicine applications using multi-well plates and have excellent material safety and foreign matter reduction qualities (para 13, 14, and 42).
3. Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Tsukada et al. (WO2017057126A1) in view of Tanaka (JP2009050194A).
Tsukada teaches all of the limitations of Claim 1 (see above). Tsukada further teaches a culture vessel plate having 96 wells where HepG2 cells were suspended in Dulbeccoo’s modified eagle medium and fetal bovine serum. Tsukada further teaches the diameter of the 96 cell aggregates was approximately 700 micrometers. Tsukada does not explicitly teach the cells seeded at 1 x 10^3 cells or the number of cell accommodation parts in which cell aggregates of HepG2 are formed is 88 or more.
Tanaka teaches the cells to be seeded at 1 x 10^4 cells/mL at a concentration of 100 microliters/well (1 x 10^3 cells).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to seed the cells in Tsukada with the concentration as taught by Tanaka. One would have been motivated to do this as the formation rate of aggregates reached nearly 100% (para 45).
Further, the cell culture performed at 37 degrees Celsius for 3 days 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 Tsukada in view of Tanaka would be capable of performing the cell culture at 37 degrees Celsius for 3 days and therefore meets 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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/J.E.L./Examiner, Art Unit 1796
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799
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