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
Applicant’s election without traverse of Group I, claims 1-10, in the reply filed on 12/24/2025 is acknowledged.
Claims 11-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/24/2025.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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 (i.e., changing from AIA to pre-AIA ) 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 1-4 and 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Nakayama et al. (US 2018/0355296 A1).
Regarding claims 1 and 4, Nakayama teaches a cell culture container including a plurality of first coated regions, on a culture surface of the cell culture container, coated by a temperature-responsive polymer or a temperature-responsive polymer composition [0009], wherein the temperature-responsive polymer or temperature-responsive polymer composition is at least one temperature-responsive polymer or temperature-responsive polymer composition selected from a temperature-responsive polymer containing N-isopropyl acrylamide units, cationic monomer units, and anionic monomer units [0013], wherein the cationic monomer is at least one selected from the group consisting of 3-(N,N-dimethylaminopropyl)-(meth)acrylamide, 3-(N,N-dimethylaminopropyl)-(meth)acrylate, aminostyrene, 2-(N,N-dimethylaminoethyl)-(meth)acrylamide, and 2-(N,N-dimethylaminoethyl)-(meth)acrylate [0015], wherein another monomer other than the N-isopropyl acrylamide, the cationic monomer, and the anionic monomer may optionally be added and polymerized with the N-isopropyl acrylamide, the cationic monomer, and the anionic monomer in manufacturing of the temperature-responsive polymer [0171], wherein examples of other monomers include acrylic acid or methacrylic acid having polyethylene glycol side chains [0182] that are esters of acrylic acid or methacrylic acid having polyethylene glycol side chains [0128, 0142], which reads on a biocompatible device which comprises on its surface an adsorbed layer of a polymer P which is a copolymer of optionally at least one macromonomer selected from an ester E of (meth)acrylic acid and polyethylene oxide, one monomer M selected from alkyl acrylamide, and at least one cationic monomer C selected from cationic ethylenically unsaturated N-containing monomers.
Nakayama does not teach a specific embodiment wherein the copolymer is a copolymer of at least one macromonomer selected from an ester E of (meth)acrylic acid and polyethylene oxide or a polyethylene glycol (meth)acrylamide, where the macromonomer is the ester E of (meth)acrylic acid and polyethylene oxide. Before the effective filing date of the claimed invention, one of ordinary skill in the art would have found it obvious to add and polymerize Nakayama’s other monomers that are esters of acrylic acid or methacrylic acid having polyethylene glycol side chains with Nakayama’s N-isopropyl acrylamide, Nakayama’s cationic monomer, and Nakayama’s anionic monomer in manufacturing of Nakayama’s temperature-responsive polymer. The proposed modification would read on wherein the copolymer is a copolymer of one macromonomer selected from an ester E of (meth)acrylic acid and polyethylene oxide as claimed, where the macromonomer is the ester E of (meth)acrylic acid and polyethylene oxide as claimed. One of ordinary skill in the art would have been motivated to do so because Nakayama teaches that another monomer other than the N-isopropyl acrylamide, the cationic monomer, and the anionic monomer may optionally be added and polymerized with the N-isopropyl acrylamide, the cationic monomer, and the anionic monomer in manufacturing of the temperature-responsive polymer [0171], that examples of other monomers include acrylic acid or methacrylic acid having polyethylene glycol side chains [0182] that are esters of acrylic acid or methacrylic acid having polyethylene glycol side chains [0128, 0142], and that the other monomers can be used to adjust the hydrophilic/hydrophobic balance apart from charge and can increase the number of variations [0184], which means that the proposed modification would have been beneficial for adjusting the hydrophilic/hydrophobic balance apart from charge and for increasing the number of variations.
Regarding claim 2, Nakayama teaches that the cell culture container [0009] is capable of easily producing large quantities of minute cellular structures [0001], which reads on where the biocompatible device is a device for cultivating cells as claimed.
Regarding clam 3, Nakayama teaches that examples of the cell culture container include commercially available plates, dishes, flasks, and glass plates [0035], which reads on where the device for cultivating cells is selected from cell culture flasks, cell culture dishes, or cell culture plates as claimed.
Regarding claim 7, Nakayama teaches that the ratio, in moles, of N-isopropyl acrylamide units to the total of N-isopropyl acrylamide units, cationic monomers units, and anionic monomers units is from 0.6 to 0.9 [0233], that when also using another monomer, the ratio, in moles, of the other monomer units to the total of N-isopropyl acrylamide units, cationic monomer units, and anionic monomer units is from 0.001 to 0.2 [0234], that the ratio of the number of cationic functional groups to the number of anionic functional groups in the temperature-responsive polymer is from 0.5 to 32 [0243], and that examples of other monomers include acrylic acid or methacrylic acid having polyethylene glycol side chains [0182] that are esters of acrylic acid or methacrylic acid having polyethylene glycol side chains [0128, 0142], which means that the ratio, in moles, of the total of cationic monomers units and anionic monomer units to the total of N-isopropyl acrylamide units, cationic monomers units, and anionic monomers units is from 1 – 0.9 = 0.1 to 1 – 0.6 = 0.4. Nakayama’s teachings therefore read on wherein the polymer P comprises optionally 0.1 – 17 mol% of the macromonomer, 50 – 90 mol% of the monomer M, and 2.8 – 39 mol% of the cationic monomer C, and where the molar amounts of the monomers sums up to 100%. The mol% of the macromonomer is based on the calculations 0.001 / (0.001 + 1) * 100% = 0.1% and 0.2 / (0.2 + 1) * 100% = 17%. The mol% of the monomer M is based on the calculations 0.6 / (1 + 0.2) * 100% = 50% and 0.9 / (1 + 0.001) * 100% = 90%. The mol% of the cationic monomer C is based on the calculations 0.1 * 0.5 / (0.5 + 1) / (1 + 0.2) * 100% = 2.8% and 0.4 * 32 / (32 + 1) / (1 + 0.001) * 100% = 39%.
Nakayama does not teach a specific embodiment where the polymer P comprises 5 – 90 mol% of the macromonomer. Before the effective filing date of the claimed invention, one of ordinary skill in the art would have found it obvious to add and polymerize Nakayama’s other monomers that are esters of acrylic acid or methacrylic acid having polyethylene glycol side chains with Nakayama’s N-isopropyl acrylamide, Nakayama’s cationic monomer, and Nakayama’s anionic monomer in manufacturing of Nakayama’s temperature-responsive polymer, and to select the ratio, in moles, of Nakayama’s other monomer units to the total of Nakayama’s N-isopropyl acrylamide units, Nakayama’s cationic monomer units, and Nakayama’s anionic monomer units to be from 0.001 to 0.2. The proposed modification would read on where the polymer P comprises 0.1 – 17 mol% of the macromonomer, which reads on the claimed mol%. One of ordinary skill in the art would have been motivated to do so because Nakayama teaches that another monomer other than the N-isopropyl acrylamide, the cationic monomer, and the anionic monomer may optionally be added and polymerized with the N-isopropyl acrylamide, the cationic monomer, and the anionic monomer in manufacturing of the temperature-responsive polymer [0171], that examples of other monomers include acrylic acid or methacrylic acid having polyethylene glycol side chains [0182] that are esters of acrylic acid or methacrylic acid having polyethylene glycol side chains [0128, 0142], that the other monomers can be used to adjust the hydrophilic/hydrophobic balance apart from charge and can increase the number of variations [0184], that when also using another monomer, the ratio, in moles, of the other monomer units to the total of N-isopropyl acrylamide units, cationic monomer units, and anionic monomer units is from 0.001 to 0.2 [0234], and that taking into consideration the reactivity in the polymerization reaction of the monomers, a person skilled in the art can appropriately adjust the ratio, in moles, of the amount of other monomers used relative to the total amount of monomers used in the manufacturing method of the temperature-responsive polymer so that the desired ratio of monomer components is obtained [0185], which means that the proposed modification would have been beneficial for adjusting the hydrophilic/hydrophobic balance apart from charge and for increasing the number of variations, and would have been beneficial for providing an amount of Nakayama’s other monomers that is suitable for Nakayama’s temperature-responsive polymer.
Regarding claim 8, Nakayama teaches that the cell culture container includes a plurality of first coated regions, on a culture surface of the cell culture container, coated by a temperature-responsive polymer [0009], which reads on a specific embodiment in which Nakayama’s plurality of first coated regions, on a culture surface of Nakayama’s cell culture container, are coated only by Nakayama’s temperature-responsive polymer and not by other ingredients, which reads on where the surface is free of other layers beside the adsorbed layer of the polymer P as claimed.
Regarding claim 9, Nakayama teaches that examples of the cell culture container include glass plates [0035], which reads on where the surface is at least partly made of glass as claimed.
Regarding claim 10, Nakayama teaches that the temperature-responsive polymer is bonded to the culture surface of the cell culture container by interaction, or non-covalent bonds [0284], which reads on where there are no covalent chemical bonds between the polymer P and the surface as claimed.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Nakayama et al. (US 2018/0355296 A1) as applied to claim 1, and further in view of Aoki et al. (JP H06339367 A, machine translation in English used for citation).
Regarding claim 5, Nakayama renders obvious the biocompatible device according to claim 1 as explained above.
Nakayama does not teach that the monomer M is C1-C6 alkyl (meth)acrylate. However, Aoki teaches methyl (meth)acrylate, ethyl (meth)acrylate, or n-butyl (meth)acrylate that is a copolymerizable monofunctional vinyl monomer [0013] that is present in a copolymer further comprising an amino group-containing vinyl monomer [0009] that is N,N-dimethylaminopropyl (meth)acrylamide, N,N-dimethylaminoethyl (meth)acrylate, N,N-diethylaminoethyl (meth)acrylate, vinylpyridine, alkylvinylpyridine, and N-vinylimidazole [0011], and optionally a polyfunctional monomer [0009] that is optionally polyethylene glycol di(meth)acrylate [0014], wherein the copolymer is present in a cell culture material [0009], wherein the copolymer can be used to coat or line the surface of culture vessels or culture beds of other plastics or glass for cell culture [0021]. Nakayama and Aoki are analogous art because both references are in the same field of endeavor of a biocompatible device which comprises on its surface an adsorbed layer of a polymer P which is a copolymer of optionally at least one macromonomer selected from an ester E of (meth)acrylic acid and polyethylene oxide, at least one monomer M, and an ethylenically unsaturated N-containing monomer. Before the effective filing date of the claimed invention, one of ordinary skill in the art would have found it obvious to add and polymerize Aoki’s methyl (meth)acrylate, ethyl (meth)acrylate, or n-butyl (meth)acrylate with Nakayama’s N-isopropyl acrylamide, Nakayama’s cationic monomer, and Nakayama’s anionic monomer in manufacturing of Nakayama’s temperature-responsive polymer. The proposed modification would read on wherein the monomer M is C1, C2, or C4 alkyl (meth)acrylate as claimed. One of ordinary skill in the art would have been motivated to do so because Aoki teaches that the methyl (meth)acrylate, ethyl (meth)acrylate, or n-butyl (meth)acrylate is a copolymerizable monofunctional vinyl monomer that is beneficial for imparting hydrophobicity to a copolymer, for adjusting a balance between hydrophilicity and hydrophobicity, for providing appropriate affinity to cells, and for imparting affinity when coating a copolymer with other materials, thereby giving it appropriate strength as a cell culture material [0013], which would have been desirable for Nakayama’s temperature-responsive polymer because Nakayama teaches that another monomer other than the N-isopropyl acrylamide, the cationic monomer, and the anionic monomer may optionally be added and polymerized with the N-isopropyl acrylamide, the cationic monomer, and the anionic monomer in manufacturing of the temperature-responsive polymer [0171], and that a cell culture container includes a plurality of first coated regions, one a culture surface of the cell culture container, coated by the temperature-responsive polymer [0009].
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Nakayama et al. (US 2018/0355296 A1) as applied to claim 1, and further in view of Hyuugaji (US 2018/0223024 A1).
Regarding claim 6, Nakayama renders obvious the biocompatible device according to claim 1 as explained above.
Nakayama does not teach that the cationic monomer C is a monomer of formula (I). However, Hyuugaji teaches ((meth) acryloyloxyethyl) trimethyl ammonium chloride [0211] or (3-(meth) acrylamidopropyl) trimethyl ammonium chloride [0212, 0213] that is a monomer from which a repeating unit is derived [0210], wherein the repeating unit is a cationic repeating unit [0201] that is a repeating unit that is optionally present with a repeating unit [0036] that is optionally polyethylene glycol (meth)acrylate [0143] and that is optionally present with a repeating unit [0036] that is optionally N-isopropyl (meth)acrylamide [0170], wherein the repeating unit is a hydrophilic repeating unit [0034] that is present in a polymer that is present in a medical device composition [0033], wherein a cell culture equipment comprises, one at least a part of a surface thereof, the polymer [0071]. Nakayama and Hyuugaji are analogous art because both references are in the same field of endeavor of a biocompatible device which comprises on its surface an adsorbed layer of a polymer P which is a copolymer of optionally at least one macromonomer selected from an ester E of (meth)acrylic acid and polyethylene oxide and of at least one cationic monomer C selected from cationic ethylenically unsaturated N-containing monomers. Before the effective filing date of the claimed invention, one of ordinary skill in the art would have found it obvious to use Hyuugaji’s ((meth) acryloyloxyethyl) trimethyl ammonium chloride or (3-(meth) acrylamidopropyl) trimethyl ammonium chloride to substitute for at least a fraction of Nakayama’s cationic monomer in manufacturing of Nakayama’s temperature-responsive polymer. The proposed modification would read on wherein the cationic monomer C is a monomer of formula (I) where R1 is H, R2 is H or methyl, R3 is C2-C3-alkylene, R4, R5, and R6 are each independently C1-alkyl, X is -O- or -NH-, and Y is Cl as claimed. One of ordinary skill in the art would have been motivated to do so because Hyuugaji teaches that the ((meth) acryloyloxyethyl) trimethyl ammonium chloride [0211] or (3-(meth) acrylamidopropyl) trimethyl ammonium chloride [0212, 0213] is a monomer from which a repeating unit is derived [0210] that is beneficial for being a cationic repeating unit [0201], which would have been beneficial for modifying cationic properties of Nakayama’s temperature-responsive polymer, which would have been desirable for Nakayama’s temperature-responsive polymer because Nakayama teaches that the temperature-responsive polymer contains N-isopropyl acrylamide units, cationic monomer units, and anionic monomer units [0013], that the cationic monomer is at least one selected from the group consisting of 3-(N,N-dimethylaminopropyl)-(meth)acrylamide, 3-(N,N-dimethylaminopropyl)-(meth)acrylate, aminostyrene, 2-(N,N-dimethylaminoethyl)-(meth)acrylamide, and 2-(N,N-dimethylaminoethyl)-(meth)acrylate [0015], that a wide range of cationic monomers can also be used [0231], and that the positive charge strength of the cationic site and the pH of the temperature-responsive polymer aqueous solution can easily be adjusted [0231].
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID KARST whose telephone number is (571)270-7732. The examiner can normally be reached Monday-Friday 8:00 AM-5:00 PM.
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/DAVID T KARST/Primary Examiner, Art Unit 1767
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