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 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 1-6, 11-13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over MA et al. (CN-102732475 B)
Claim 1: Ma teaches a substrate comprising cellulose among other polysaccharides (translation copy, page 3, 6th paragraph); the cellulose is modified with a cationic substituent (i.e. positive charge) and then bonded with a polypeptide (Ma, translation copy, page 3, last paragraph). Cellulose is inherently porous. The cellulose is in the form of particles because the particle size diameter is described in Ma (translation copy, page 3). Alternatively, Ma does not explicitly describe whether the cellulose is porous. In the same field of endeavor, namely polypeptide bonded-cellulose particles, JP’086 teaches cellulose porous particles composed of cellulose, wherein the cellulose composing the cellulose porous particles having a polypeptide bonded to the cellulose (translation copy, page 5, 3rd paragraph). The cellulose porous particles include a spacer which is a hydrophilic polymer having a cationic group (translation copy, paragraph bridging pages 6, 1st and 2nd paragraph) and thus the surface of the cellulose is deemed to be modified with a cationic substituent.
Claim 2: Ma teaches the charge density of the micro-carrier being most preferably 0.5 to 5 mmol/g dry (translation copy, page 3, 6th paragraph) which is the same as the claimed range.
Claims 3-4: The polypeptide is an adhesive peptide, i.e. gelatin (translation copy page 3, 2nd paragraph) including at least an Arg-Gly-Asp fragment (translation copy, page 3, 3rd paragraph).
Claims 5-6: Ma teaches the loading amount (dosage) of the polypeptide per cellulose being 100 mmol to 50 mmol/g (translation copy, page 5, 2nd paragraph) which overlaps the broad range of 10 nmol/g to 1 mmol/g.
Claim 7: Because a fragment of the polypeptide includes Arg-Gly-Asp (see claims 3-4) above, the number of amino acid residues in the polypeptide is within the claimed range of 5 to 30 residues.
Claim 11: Ma teaches the particle size of the porous particles (i.e. micro-carrier) being 50-800 µm (translation copy, page 3, 8th paragraph) which substantially overlaps the claimed range of mean particle size being from 100 µm to 1000 µm.
Claims 12-13: Ma teaches the cationic substituent comprising an amino group (amine or amine salt) with preference to a tertiary amino group (NH2R1, NHR1R2, NR1R2R3 and R4-CO-NH-R5) (translation copy, page 5, 3rd paragraph).
Claim 15: Ma teaches the micro-carrier is micro-carrier for cell culture (claim 1; translation copy, page 7, 1st paragraph).
4. Claims 1-13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over MA et al. (CN-102732475 B) in view of HARA et al. (JP-2022063983 A)
Claim 1: Ma teaches a substrate comprising cellulose among other polysaccharides (translation copy, page 3, 6th paragraph); the cellulose is modified with a cationic substituent (i.e. positive charge) and then bonded with a polypeptide (Ma, translation copy, page 3, last paragraph). The cellulose is in the form of particles because the particle size diameter is described in Ma (translation copy, page 3). Ma does not explicitly describe whether the cellulose is porous. In the same field of endeavor, namely modified-cellulose particles as carrier for cell culturing, Hara teaches cellulose porous particles being modified with a cationic substituents. The cellulose particles are porous (Hara, abstract). Hara states that porous microcarriers, the cells can be efficiently cultured and grown (translation copy, page 3, first paragraph). In light of Hara’s teaching regarding the advantages of porous cellulose, the POSITA would be motivated to utilize porous cellulose particles in the cellulose substrate of Ma.
Claim 2: Ma teaches the charge density of the micro-carrier being most preferably 0.5 to 5 mmol/g dry (translation copy, page 3, 6th paragraph) which is the same as the claimed range.
Claims 3-4: The polypeptide is an adhesive peptide, i.e. gelatin (translation copy page 3, 2nd paragraph) including at least an Arg-Gly-Asp fragment (translation copy, page 3, 3rd paragraph).
Claims 5-6: Ma teaches the loading amount (dosage) of the polypeptide per cellulose being 100 mmol to 50 mmol/g (translation copy, page 5, 2nd paragraph) which overlaps the broad range of 10 nmol/g to 1 mmol/g.
Claim 7: Because a fragment of the polypeptide includes Arg-Gly-Asp (see claims 3-4) above, the number of amino acid residues in the polypeptide is within the claimed range of 5 to 30 residues.
Claim 8: Hara teaches the specific surface area of the dry cellulose porous particles is 0.3 m²/g to 4.4 m²/g (Hara, translation copy, page 3, 2nd paragraph).
Claims 9-10: Hara teaches the cellulose having multiple pores, with a mean pore size of 5 µm to 100 µm, wherein the pores form a continuous pore structure with adjacent pores mutually communicating by openings in the membranes dividing them. (Hara, translation copy, page 2, 6th paragraph).
Claim 11: Ma teaches the particle size of the porous particles (i.e. micro-carrier) being 50-800 µm (translation copy, page 3, 8th paragraph) which substantially overlaps the claimed range of 100 µm to 1000 µm. Additionally, Hara teaches porous cellulose having average particle size of 100 to 1000 mm (Hara, page 2, 6th paragraph), which is the same as the claimed range.
Claims 12-13: Ma teaches the cationic substituent comprising an amino group (amine or amine salt) with a preference to a tertiary amino group (NH2R1, NHR1R2, NR1R2R3 and R4-CO-NH-R5) (translation copy, page 5, 3rd paragraph).
Claim 15: Ma teaches the micro-carrier is micro-carrier for cell culture (claim 1; translation copy, page 7, 1st paragraph).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Ma and Hara as applied to claims 1-13 and 15 above, and further in view of JP-04-173086 (“JP’086”)1
Ma and Hara teach the claimed cellulose porous particles as discussed above. Neither teaches the use of a spacer. In the same field of endeavor, namely cellulose particles bonded with a polypeptide to be used as carriers for cell culturing, JP’086 teaches cellulose porous particles composed of cellulose, wherein the cellulose composing the cellulose porous particles having a polypeptide bonded to the cellulose (translation copy, page 5, 3rd paragraph). JP’086 suggests the use of spacer in order to enhance the adhesion and spreading function of cells (JP’086, translation copy, page 6, first paragraph). Therefore, the POSITA would be motivated to interpose a spacer between the peptide and the cellulose particles of Ma as taught by JP’086. JP’086 teaches the spacer being polyethyleneimine (“PEI”) having a molecular weight of at least 3000 (translation copy, page 6); PEI has a base structure (CH2CH2NH)n which corresponds to a chain length of 8 atoms and thus falls within the claimed chain length range of 5 to 20 atoms.
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/HOA (Holly) LE/Primary Examiner, Art Unit 1788
1 Translation Copy provided by Applicant.