DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant's election without traverse of the species of cationic moiety in claim 2 and carboxybetaine methyl methacrylate in claim 4, in the reply filed on 10 September 2025 is acknowledged. Claims 2-4 have been amended. Claims 1-11 are currently pending and under examination.
This application claims benefit of priority to Taiwan Patent Application No. 111126002, filed July 12, 2022.
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.
Claim 10 is 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.
Claim 10 recites that the thickness of the plastic bag body ranges from 50 µm to 400 µm. This claim is indefinite, because it is unclear if the plastic bag body as recited in this claim is intended to include just the plastic bag body, or instead, the plastic bag body including the zwitterionic polymer plastic surface.
Claim Rejections - 35 USC § 102
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.
Claims 1-9 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jiang et al. (WO 2020/186134; Published 2020).
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With regard to claim 1, referring to Fig. 22A-B reproduced here, Jiang et al. teach a platelet bag, the bag having a commercialized plastic bag body outer surface, a zwitterionic polymer plastic surface facing the platelet space, and a hydration layer attached onto the zwitterionic polymer plastic surface, the platelet space being surrounded by the hydration layer (Fig. 22A-B; p. 64, line 9-13).
Jiang et al. teach a cell-containing bag as claimed, including all components as claimed. As the bag and its components cannot be separated from their properties, the platelet bag as taught by Jiang et al. is, or is capable of being used as, a cell culture bag, and the platelet space is a cell culture space.
With regard to claims 2-5, Jiang et al. teach that the PCB random copolymer is carboxybetaine methacrylate (CBMA), which is carboxybetaine methyl methacrylate (Fig. 22B; p. 11, line 21-31). CBMA is a zwitterionic polymer where one molecular end has an acrylate group and another molecular end has a cationic moiety, the cationic moiety being a quaternary ammonium group.
With regard to claim 5, as noted, Jiang et al. teach that the PCB random copolymer is carboxybetaine methacrylate (CBMA) (Fig. 22B; p. 11, line 21-31). As CBMA is the elected and preferred zwitterionic polymer (see instant claim 4), CBMA has a number average molecular weight within the range of 5,000-10,000 g/mol.
With regard to claim 6, referring to Fig. 22A-B reproduced above, Jiang et al. teach that the plastic bag body and the zwitterionic polymer plastic surface are integrally formed (see Fig. 22A).
With regard to claim 7, the plastic bag body and the zwitterionic polymer plastic surface are formed from a composite polymer material, including CBMA (Fig. 22A-B; p. 11, line 21-31), and the total weight of the zwitterionic polymer includes 1.00 wt% (p. 55, line 33 to p. 56, line 3), which is fully encompassed within 1 wt% to 3 wt%.
With regard to claim 8, the zwitterionic polymer plastic surface is formed on the plastic bag body by coating (p. 46, line 1-5).
With regard to claim 9, the total weight of the CB copolymer includes 0.03 wt% (300 ppm) and 0.06 wt% (600 ppm) (p. 55, line 33 to p. 56, line 3), which are fully encompassed within 50 ppm to 1000 ppm.
With regard to claim 11, Jiang et al. teach a cell-containing bag as claimed, including all components as claimed. As the bag and its components cannot be separated from their properties, the bag as taught by Jiang et al. necessarily has a water vapor transmission rate that ranges from 2 g/(m2·day) to 10 g/(m2·day), and an oxygen transmission rate that is higher than 200 g/(m2·day).
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.
Claims 1 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Jiang et al., in view of Hmel et al. (Physical and thermal properties of blood storage bags: implications for shipping frozen components on dry ice, Blood Components, Transfusion, Vol. 42, (July 2002), pp. 836-846).
The teaching of Jiang et al. as applied to claim 1 have been set forth above.
With regard to claim 10, Jiang et al. further teach that the commercialized platelet bag is made of plasticized PVC (p. 61, line 31-33). However, Jiang et al. do not specifically teach the thickness of the commercialized platelet bag.
Hmel et al. teach that blood component storage bags made of PVC range in thickness from 0.38 to 0.41 mm (380 to 410 µm) (Table 2).
It would have been obvious to one of ordinary skill in the art to combined the teachings of Jiang et al. with Hmel et al., because both teach blood component storage bags that are made of PVC. The thickness of PVC blood component storage bags ranging from 380 to 410 µm is known in the art as taught by Hmel et al. As Jiang et al. teach the use of PVC commercial platelet storage bags, it would have been obvious to one of ordinary skill in the art to utilize a bag thickness within the range taught by Hmel et al. that is known for commercial PVC blood storage bags, including amounts within the range of 380 to 410 µm, which would encompass bag thicknesses of 380-400 µm.
Conclusion
No claims are allowable.
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/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653