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 .
REJECTIONS WITHDRAWN
All previous rejections are withdrawn
REJECTIONS REPEATED
There are no rejections repeated.
NEW REJECTIONS
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.
Claims 1 and 8 are 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.
The term “high” in claims 1 and 8 is a relative term which renders the claim indefinite. The term “high” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
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.
Claim(s) 1-14 and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Niazi (US 2012/0077243) in view of Olsen et al. (US 2017/0175066).
For the purposes of searching for and applying prior art under 35 U.S.C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, "consisting essentially of" will be construed as equivalent to "comprising." (MPEP 2111.03(III))
Claims 1 and 8 recites an intended use (to provide a non-tacky exterior surface layers) and has been given little too no patentable weight since it has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations (MPEP 2114(II)).
Niazi discloses a multilayer bioreactor bag (20) made from a multilayer film (10) comprising: inner and outer exterior surface layers (11, 16) on opposing faces of the multilayer film (10) consisting essentially of a low density polyethylene having a high level of purity and without additives (since no additives are present, paragraphs [0021]) and having a thickness in a range of 10-100 microns and a density in a range of 0.91 to 0.94 g/cc (since LDPE has a density of 0.917-0.930 g/cc) to provide a non-tacky exterior surface layers (since LDPE layers are disclosed) (paragraphs [0011-0012], [0020-0021], [0094], [0097]). Niazi also discloses interior layers disposed between the inner and outer exterior layers comprising a thickness in a range of 100-250 microns (paragraph [0097]).
Niazi does not disclose interior layers disposed between the exterior surface layers comprising a gas barrier layer (14) and a structural layer (12) comprising an ethylene alpha-olefin elastomer having a density in a range of 0.87-0.91 to provide a flexible support to the multilayer film; and one or more tie layers (13, 15) to bond the interior layers to one or more of the ethylene alpha-olefin elastomer structural layer (12) and surface layers (11, 16).
Olsen discloses disclose interior layers disposed between the exterior surface layers comprising a gas barrier layer (14) and a structural layer (12) comprising an ethylene alpha-olefin elastomer having a density in a range of 0.87-0.91 to provide a flexible support to the multilayer film; and one or more tie layers (13, 15) to bond the interior layers to one or more of the ethylene alpha-olefin elastomer structural layer (12) and surface layers (11, 16) in a bioreactor bag for the purpose of providing improved biological processing and improved mechanical properties (paragraphs [0002], [0015-[0023], [0072-0076], [0103-0105], [0114-0116], [0124-0131], [0134]).
Therefore it would have been obvious to one of ordinary skill in the art at the time applicant’s invention was made to have provided disclose interior layers disposed between the exterior surface layers comprising a gas barrier layer (14) and a structural layer (12) comprising an ethylene alpha-olefin elastomer having a density in a range of 0.87-0.91 to provide a flexible support to the multilayer film; and one or more tie layers (13, 15) to bond the interior layers to one or more of the ethylene alpha-olefin elastomer structural layer (12) and surface layers (11, 16) in Niazi in order to provide improved biological processing and improved mechanical properties as taught or suggested by Olsen.
Although Olsen does specifically recite the words ethylene alpha-olefin elastomer, Olsen discloses Santoprene (paragraphs [0084], [0104]) which contains EPDM which is an ethylene alpha olefin elastomer.
Olsen discloses wherein the multilayer film further comprises one or more tie layers (13, 15) to bond the interior layers to one or more of the ethylene alpha-olefin elastomer structural layer (12) and surface layers (11, 16), wherein the one or more tie layers (13, 15) comprise a mixture of an ethylene alpha-olefin elastomer and a polyolefin copolymer grafted with maleic anhydride, wherein the gas barrier layer (14) is EVOH, wherein the interior layers comprise one or more of anhydride-modified polyethylene, ethylene/unsaturated acid copolymer, ethylene/unsaturated ester copolymer, anhydride-modified polyolefin, polyurethane, and mixtures thereof and comprising a single use bioprocessing bag for growing cell media wherein: the ethylene alpha-olefin elastomer is ethylene based octene-1 elastomer; and the gas barrier layer is ethylene vinyl alcohol copolymer (paragraphs [0002], [0015-[0023], [0072-0076], [0103-0105], [0114-0116], [0124-0131], [0134]).
Olsen discloses wherein the multilayer film comprises six layers (Layers 1-6) in serial order as listed below: Layer 1: the inner exterior surface layer (11); Layer 2: a first ethylene alpha-olefin elastomer structural layer (12): Layer 3: a first tie layer (13); Layer 4: the gas barrier layer (14): Layer 5: a second tie layer (15); and Layer 6: the outer exterior surface layer (16) (paragraphs [0002], [0015-[0023], [0072-0076], [0103-0105], [0114-0116], [0124-0131], [0134]).
With regard to claims 5-6, 11-12 and 20, modified Niazi does not specifically disclose the individual thicknesses, densities and thickness ratios recited in claims 5-6, 11-12 and 20. However, discovering the optimum range or value for a result effective variable is obvious and well within the level of one of ordinary skill in the art (MPEP 2144.05 (II)). It would have been obvious to one of ordinary skill in the art at the time applicant’s invention was made to have provided applicant’s recited thicknesses, densities and thickness ratio in claims 5-6, 11-12 and 20 in order to provide improved mechanical properties.
Claim(s) 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Niazi (US 2012/0077243) in view of Olsen et al. (US 2017/0175066), as applied to claims 1-14 and 18-20 above, and further in view of De Brouwer et al. (US 2019/0119620).
Modified Niazi does not disclose an inflatable bag (20) having an enclosed central chamber (21) for holding a cell or bioreactor liquid media, the inflatable bag (20) comprising a top sheet (22) of multilayer polymer material and a bottom sheet (24) of multilayer polymer material, wherein the multilayer polymer material comprises the multilayer film (10), wherein the top sheet (22) and the bottom sheet (24) are heat sealed along perimeter edges to form the central chamber (21).
De Brouwer discloses an inflatable bag (20) having an enclosed central chamber (21) for holding a cell or bioreactor liquid media, the inflatable bag (20) comprising a top sheet (22) of multilayer polymer material and a bottom sheet (24) of multilayer polymer material, wherein the multilayer polymer material comprises the multilayer film (10), wherein the top sheet (22) and the bottom sheet (24) are heat sealed along perimeter edges to form the central chamber (21) (paragraphs [0001], [0007-0008], [0047) in a bioreactor for the purpose of providing improved biological processing.
Therefore it would have been obvious to have provided an inflatable bag (20) having an enclosed central chamber (21) for holding a cell or bioreactor liquid media, the inflatable bag (20) comprising a top sheet (22) of multilayer polymer material and a bottom sheet (24) of multilayer polymer material, wherein the multilayer polymer material comprises the multilayer film (10), wherein the top sheet (22) and the bottom sheet (24) are heat sealed along perimeter edges to form the central chamber (21) in modified Niazi in order to provide improved biological processing as taught or suggested De Brouwer.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Niazi (US 2012/0077243) in view of Olsen et al. (US 2017/0175066) and De Brouwer et al. (US 2019/0119620), as applied to claims 15-16 above, and further in view of Maggiore (US 2019/0184353).
Modified Niazi does not disclose wherein a handle opening (25) is provided in a top perimeter edge of the bag (20); and port openings for receiving tubes (27) are provided in a bottom perimeter edge of the bag (20).
Maggiore discloses wherein a handle opening (25) is provided in a top perimeter edge of the bag (20); and port openings for receiving tubes (27) are provided in a bottom perimeter edge of the bag (20) (paragraphs [0005-0010], Figs. 3A-3B) for the purpose of providing improved biological processing and the ability to hang the bioreactor bag.
Therefore it would have been obvious to one of ordinary skill in the art at the time applicant’s invention was made to have provided wherein a handle opening (25) is provided in a top perimeter edge of the bag (20); and port openings for receiving tubes (27) are provided in a bottom perimeter edge of the bag (20) in modified Niazi in order to provide improved biological processing and the ability to hang the bioreactor bag as taught or suggested by Maggiore.
ANSWERS TO APPLICANT’S ARGUMENTS
Applicant’s arguments of 6/15/26 have been carefully considered but are deemed unpersuasive. Applicant never addressed the 112 rejections so they are repeated above.
Applicant argues, “The secondary reference Olsen, taken alone or in combination with Niazi, fails to teach or suggest applicant's claimed structure. Olsen mentions the use of additives, such as anti-block agents, only in regard to the interior layers and thus specifically precludes their use in the outer layer ("desirably in layers other than the contact layer"). Thus, the relied upon teachings of Olsen are directly contrary to applicant's claimed invention and for this reason alone the 103 rejection is not valid.”
Niazi discloses a multilayer bioreactor bag (20) made from a multilayer film (10) comprising: inner and outer exterior surface layers (11, 16) on opposing faces of the multilayer film (10) consisting essentially of a low density polyethylene having a high level of purity and without additives (since no additives are present, paragraphs [0021]).
Applicant argues, “Firstly, applicant specifies an alpha olefin copolymer as the most flexible layer (versus TPE in Olsen) and applicant specifies both the thickness and density ranges of the alpha olefin copolymer to achieve such flexibility in the composite structure (while also reciting the thickness and density ranges of the contact layers -- in direct contrast to Olsen's reliance on TPE as the flexible layer.”
Although Olsen does specifically recite the words ethylene alpha-olefin elastomer, Olsen discloses Santoprene (paragraphs [0084], [0104]) which contains EPDM which is an ethylene alpha olefin elastomer.
Applicant argues, “Secondly, applicant positions the alpha-olefin layer on the other side of EVOH (towards the inside of the bag) -- in direct contrast to Olsen's position towards the outside of the bag.”
Claim 1 does not specifically recite that the alpha-olefin layer is towards the inside of the bag.
Applicant argues, “Thirdly and contrary to the Examiner's premise, applicant does not claim a tie layer between PE and alpha olefin copolymer. Olsen's only mention of alpha olefin copolymer is under the PE umbrella -- which in Olsen's examples resides only in the exterior contact layer and thus produces high tackiness. In contrast, applicant claims non-tacky exterior contact layers and provides alpha olefin copolymer in the interior layer.”
Although Olsen does specifically recite the words ethylene alpha-olefin elastomer, Olsen discloses Santoprene (paragraphs [0084], [0104]) which contains EPDM which is an ethylene alpha olefin elastomer. Olsen discloses that the Santoprene can be a structural layer which is an interior layer (paragraphs [0103-0105]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL C MIGGINS whose telephone number is (571)272-1494. The examiner can normally be reached Monday-Friday, 1-9 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Aaron Austin can be reached at 571-272-8935. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL C MIGGINS/Primary Examiner, Art Unit 1782
MCM
August 16, 2026
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