DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Response to Amendments/Arguments
Receipt is acknowledged of applicant's amendment filed 9/17/2025.
Claims 1-13 and 16-18 are pending. Claim 1 is amended. New claims 17-18 are added.
Applicant's amendments and arguments with respect to the rejection of present claims 1 – 4, 6, 8 – 14 under 35 U.S.C. 103(a) as being unpatentable over Kani et al (U.S. Patent Application Publication No. 2012/0052225 A1) in view of Shibata et al (U.S. Patent No. 4,429,079) have been fully considered and are persuasive. Applicant's arguments regarding previously presented claims 15-16, including the omission of examination and rejection of claims 15-16 have also been considered. Accordingly, the previous rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of newly discovered reference.
Due to the new ground of rejection, the present action is not made Final.
Information Disclosure Statement
The information disclosure statement filed June 7, 2024 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because Non – Patent Literature citation 24 does not contain a date. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Claim Rejections – 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-4, 6, 8-13 and 16-18 are rejected under 35 U.S.C. 103(a) as being unpatentable over Broadley et al. (US 2010/0028990; “Broadley”) in view of Kani et al (U.S. Patent Application Publication No. 2012/0052225 A1; “Kani”) in view of Shibata et al (U.S. Patent No. 4,429,079; “Shibata”).
Regarding Claim 1, Broadley teaches a bioreactor (para [0029] [0042]-[0045]) comprising a pouch (para [0031], [0032] the bag) made from a multilayer film and a stirring device (para [0031], [0042], stirring device 210) for mixing the content of the pouch, said stirring device being configured to perform a movement selected from swinging, orbital or axial movement (para [0031], [0042] [0045], the stirring device is configured to perform a movement such as oscillating or back-and forth motion, and thus considered as meeting the claimed limitations).
Broadley teaches its pouch is made from a multilayer film (para [0031], [0032]), but Broadley does not teach the specific multilayer film as instantly claimed in claim 1.
Kani teaches a film (paragraph 0033) that is a multilayer film that provides superior flex crack resistance that comprising two thermoplastic resin layers and a layer of EVOH composition (paragraph [0181] [0257]). The film is processed into a package for medical products (paragraph 0187). One of the thermoplastic resin layers is a contact layer and the other is an outer layer, and the layer of EVOH composition is a core layer. The outer layer and the core layer are made integral with a tie layer, because an adhesive layer is disclosed between the outer layer and the core layer (paragraph 0181). The ethylene vinyl alcohol has an ethylene content of 27 to 35 mol% (paragraph 0042) and the EVOH composition also comprises an ionomer acid ethylene copolymer (metal salt of ethylene and unsaturated carboxylic acid copolymer; paragraph 0086); the tie layer comprises ethylene — ethyl acrylate copolymer graft modified with maleic anhydride (paragraph 0176). The outer layer is selected from a group of resins that includes, for example, olefin copolymers such as ethylene – propylene copolymer (paragraph 0171). Kani teaches its multilayer film is suitable for making a pouch (bag; paragraph 0194). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05.
Kani does not specifically teach an ethylene-olefin copolymer having a density in the range 0.870 g/cm3 to 0.905 g/cm3 and a polyolefin having a density in the range 0.910 g/cm3 to 0.940 g/cm3, as instantly claimed
Shibata teaches a film (column 1, lines 6-12) comprising a first ethylene α-olefin copolymer having a density of 0.910 g/cm3 to 0.940 g/cm3 and a second ethylene α-olefin copolymer having a density of 0.870 g/cm3 to 0.900 g/cm3 (column 1, lines 65 — 68; column 2, lines 1 — 13) for the purpose of obtaining a film having excellent transparency and impact strength (column 2, lines 1 — 14). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05.
It would have been obvious for one of ordinary skill in the art to modify the multilayer film of Kani in view the teachings of Shibata, to employing the ethylene α-olefin copolymer blend taught by Shibata as the outer layer resin composition (i.e., which blend includes a first ethylene α-olefin copolymer having a density of 0.910 g/cm3 to 0.940 g/cm3 and a second ethylene α-olefin copolymer having a density of 0.870 g/cm3 to 0.900 g/cm3), to provide an improved multilayer film having excellent transparency and impact strength as taught by Shibata; and further, it would have been obvious for one of ordinary skill in the art to employ the above modified multilayer of Kani as the flexible multilayer bag/pouch of Broadley for the bioreactor of Broadley, because Kani teaches its multilayer film is suitable for making bag/pouch for various applications that providing superior flex crack resistance as taught by Kani (para [0257]), which would have predictably arrived a satisfactory bioreactor that is the same as instantly claimed.
Regarding Claim 2, Kani teaches the ethylene vinyl alcohol is flex — crack resistant (paragraph 0025)
Regarding Claims 3 and 16, Kani teaches an ionomer that is a metal salt of ethylene and unsaturated carboxylic acid copolymer, wherein the carboxyl group is neutralized by the metal (paragraph 0086). Kani et al fail to disclose an acrylic acid copolymer and a metal that is zinc. However, it would have been obvious for one of ordinary skill in the art to select Surlyn, as disclosed in page 5, lines 6 – 10 of the instant specification, as a metal salt of ethylene and unsaturated carboxylic acid copolymer, wherein the carboxyl group is neutralized by the metal, is disclosed. An unsaturated carboxylic acid copolymer that is an acrylic acid copolymer and a metal that is zinc would therefore be obtained.
Regarding Claim 4, Shibata teaches a suitable copolymer of ethylene with octene, because an olefin having 3 to 10 carbon atoms is taught (column 1, lines 65 — 68; column 2, lines 1 — 13).
Regarding Claim 6, Kani teaches the adhesive layer comprises ethylene – ethylene acrylate copolymer grafted with maleic anhydride (paragraph 0176).
Regarding Claims 8 and 10, Kani teaches the ionomer is an olefin based polymer (paragraph 0081) and the mass ratio of ethylene – vinyl alcohol to ionomer is 70/30 to 80/20 (paragraph 0156). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05.
Regarding Claim 9, Shibata teaches a mixture of its two-component ethylene α-olefin blend of 40-95% and 5-60% (column 1, lines 65 — 68; column 2, lines 1 — 13), i.e., the (E) and (F) with a mass ratio (E)/(F) of 40/60 to 95/5, which range overlaps with the instantly claimed greater than or equal to 5/95. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05.
Regarding Claim 11, Kani teaches its multilayer film includes suitable additional layers as desired, and Kani teaches as in one of its embodiments a multilayer film including a contact layer comprising a copolymer of ethylene and σ-olefin, in addition to the core layer and tie layer (para [0171] [00181]). Kani teaches its multilayer film is suitable for packaging medical products (para [0187]), meeting the claimed limitations.
Regarding Claim 12, Kani teaches its multilayer film includes suitable additional layers as desired, and Kani teaches as in one of its embodiments a multilayer film includes two or more layers of ethylene vinyl alcohol (at least one; paragraph 0170); and thus, the additional layer of ethylene vinyl alcohol, is between the first layer of ethylene vinyl alcohol and the first tie layer, meeting the claimed limitations.
Regarding Claim 13, Kani teaches its multilayer film includes suitable additional layers as desired, and Kani teaches as in one of its embodiments a multilayer film including contact layer, first tie layer, core layer, second tie layer and outer layer (para [0171] [00181]), and Kani teaches coextrusion of the layers (paragraph 0174), meeting the claimed limitations.
Regarding Claim 17, Broadley teaches its bioreactor (para [0029] [0042]-[0045]) comprising a pouch of various shapes as desired, suitable shapes includes 2D or 3D pouch (para [0031]-[0034]).
Regarding Claim 18, Broadley teaches its bioreactor (para [0029] [0042]-[0045]) comprising a pouch of various size and volumes as desired depending on the desired end applications, including up to 3,000 liters (para [0031]-[0034]).
Claim 5 is rejected under 35 U.S.C. 103(a) as being unpatentable over Broadley view of Kani and Shibata as applied to claim 1 above, and further in view of Ralph (U.S. Patent No. 5,279,872).
The limitations of claim 1 are taught by Broadley and Kani and Shibata as discussed above.
Regarding claim 5, modified Broadley teaches a bioreactor includes a film comprising ethylene α-olefin copolymer as discussed above. However, modified Broadley does not teach a copolymer that is a plastomer polyolefin.
However, Ralph discloses that an ethylene α-olefin copolymer having the density of very low density polyethylene (column 4, lines 61 — 68), which is between about 0.860 to about 0.914 g/cm3 (column 4, lines 35 — 50), is non-elastomeric, or is alternatively a plastomer, for the purpose of providing elastomeric properties (column 4, lines 61- 68).
It would have been obvious for one of ordinary skill in the art to further modify the modified Broadley, to select and include as the second ethylene α-olefin copolymer (taught by Shibata) a plastomer as taught by Ralph, in order to provide elastomeric properties, as the density of the second ethylene α-olefin copolymer is the density of very low density polyethylene, and additionally, because it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim 7 is rejected under 35 U.S.C. 103(a) as being unpatentable over Broadley view of Kani and Shibata as applied to claim 1 above, and further in view of Kennedy et al (U.S. Patent No. 6,682,825).
The limitations of claim 1 are taught by Broadley and Kani and Shibata as discussed above.
Regarding claim 7, modified Broadley teaches a bioreactor includes a film comprising ethylene α-olefin copolymer as discussed above. However, modified Broadley does not teach a resin that is a plastomer polyolefin having from 4 to 8 carbon atoms.
Kennedy et al teach a film comprising a plastomer (column 2, lines 57 – 66) that is a polyolefin (column 6, lines 29 - 41) having 4 to 8 carbon atoms (column 14, lines 55 – 65) for the purpose of obtaining a film that is sealable (column 2, lines 57 – 66).
It would have been obvious for one of ordinary skill in the art to further modify the modified Broadley in view the teachings of Kennedy, to select and include a plastomer polyolefin having from 4 to 8 carbon atoms in the tie layer as taught by Kennedy, in order to obtain a film that is sealable as taught by Kennedy (column 14, lines 55 – 65, column 2, lines 57 – 66).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YAN LAN whose telephone number is (571)270-3687. The examiner can normally be reached Monday - Friday 7AM-4PM.
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/YAN LAN/Primary Examiner, Art Unit 1782
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