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 .
This Office Action is in response to the paper filed 2 April 2026. Claim 1 has been amended. Claims 12 and 13 are newly added. Claims 1-13 are currently pending and under examination.
This application claims benefit of priority to Taiwan Patent Application No. 111126002, filed July 12, 2022.
Withdrawal of Rejections:
The rejection of claim 10 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second
paragraph, as being indefinite, is withdrawn.
The rejection of claims 1-9 and 11 under 35 U.S.C. 102(a)(1) as being anticipated by Jiang et al., is withdrawn.
The rejection of claims 1 and 10 under 35 U.S.C. 103 as being unpatentable over Jiang et al., in view of Hmel et al., is withdrawn.
New Objections/Rejections Necessitated by Amendment:
Claim Objections
Claim 12 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Claim 13 is likewise objected to as this claim depends from claim 12.
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 1-9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Jiang et al. (WO 2020/186134; Published 2020 – Previously presented), in view of Impact Plastics (Learn About Your Packaging Materials: 5 Facts About Low Density Polyethylene, Sept. 28, 2017, Available online at: blog.impactplastics.co/blog/learn-about-your-plastic-sheet-5-facts-about-low-density-polyethylene).
With regard to claim 1, referring to Fig. 22A-B reproduced here, Jiang et al. teach a
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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).
While Jiang et al. teach that the plastic surface includes polyethylene (p. 3, line 18), it is not specifically taught that the polyethylene is low density polyethylene (LDPE).
Impact Plastics teach that LDPE is a very versatile plastic often used in flexible film and bag applications, as it has desirable characteristics including flexibility, transparency, excellent resistance to chemicals and moisture, safety, low cost, and is recyclable (p. 1-2).
It would have been obvious to one of ordinary skill in the art to combine the teachings of Jiang et al. and Impact Plastics, because both teach polyethylene plastic and its use in bags. The use of LDPE in plastic bags in known in the art as taught by Impact Plastics. The use of LDPE as the polyethylene in the bag of Jiang et al. amounts to the simple substitution of polyethylene generally for a known type of polyethylene usable in for plastic bags. The use of LDPE as the polyethylene in the bag of Jiang et al. would have been expected to predictably and successfully provide a polyethylene appropriate for production of the bag as taught.
Claim 1 as amended includes a composite polymer material, which is produced by the claimed process. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Here, the composite polymer material of Jiang et al. and Impact Plastics includes a plastic material and a zwitterionic polymer, which are similarly combined. The composite polymer material is used for the same purpose as claimed: to form a bag. Functionally, the composite polymer material of Jiang et al. and Impact Plastics is the same as the claimed composite polymer material. Therefore, the composite polymer material of Jiang et al. and Impact Plastics is the same as, or would have rendered obvious, the composite polymer material produced by the claimed process.
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"The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983).
Taken together, Jiang et al. and Impact Plastics render obvious 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 rendered obvious by Jiang et al. and Impact Plastics 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 Impact Plastics, as applied to claim 1 above, and further 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 – Previously Presented).
The teaching of Jiang et al. and Impact Plastics 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. and Impact Plastics with Hmel et al., because Jiang et al. and Hmel et al. 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.
Response to Arguments
With regard to Jiang et al., Applicant argues that Jiang et al. do not teach the claims as amended, including that the plastic material and the zwitterionic polymer are melted and mixed so as to form the composite polymer material, and instead teach a different method of production, wherein the claimed method provides a cell culture bag where the zwitterionic polymer is distributed throughout the plastic bag body and present at its surface. Additionally, Hmel does not cure the noted deficiency. With regard to new claim 12, Applicant urges that CB has to be copolymerized with BMA and benzophenone to form the zwitterionic copolymer, and thus the zwitterionic polymer does not “consist of” CB.
With regard to new claim 12, Applicant’s arguments have been found persuasive.
Applicant’s additional arguments have been fully considered, but have not been found persuasive.
With regard to the arguments that Jiang et al. do not teach production of the bag as now claimed, as discussed previously, claim 1 as amended includes a composite polymer material, which is produced by the claimed process. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Here, the composite polymer material of Jiang et al. and Impact Plastics includes a plastic material and a zwitterionic polymer, which are similarly combined. The composite polymer material is used for the same purpose as claimed: to form a bag. Functionally, the composite polymer material of Jiang et al. and Impact Plastics is the same as the claimed composite polymer material. Therefore, the composite polymer material of Jiang et al. and Impact Plastics is the same as, or would have rendered obvious, the composite polymer material produced by the claimed process.
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"The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983).
With regard to Hmel, the noted deficiencies of Jiang et al. have been addressed above.
Conclusion
No claims are allowable, however claim 12 appears to be free of the art.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER M.H. TICHY whose telephone number is (571)272-3274. The examiner can normally be reached Monday-Thursday, 9:00am-7:00pm ET.
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/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653
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