DETAILED ACTION
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Rejections - 35 USC § 103
Claims 1-6, 11-13 and 15 stand 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 µmol 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).
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 µmol 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 stand 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").
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.
Response to Arguments
Applicant alleges that the microcarrier of MA is not porous. This directly contradicts the description in MA where it is stated that the microcarrier may be a gel type of microporous having a pore diameter of 0.05 to 50 microns (MA, translation copy, page 2, penultimate paragraph). MA does not specify whether polysaccharide is porous; however, as polysaccharide is cellulose and as stated in the rejection that cellulose is inherently porous; therefore, contrary to Applicant’s allegation, the microcarrier of MA and polysaccharide, in particular, are porous. For supporting document, see attachment, FERTONANI et al., A Comprehensive Overview of Cellulose and Its Derivatives: Structural Features and Emerging Applications, Journal of Applied Polymer Science, 2026; 143:e58090. Therefore, contrary to Applicant’s argument, the combination of MA with HARA and further with JP’086 is proper.
Applicant's arguments filed July 2, 2026 have been fully considered but they are not persuasive for the reasons stated above.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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HOA (Holly) LE
Primary Examiner
Art Unit 1788
/HOA (Holly) LE/Primary Examiner, Art Unit 1788
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