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 .
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.
Claims 6, 7, 9, 11-14, 16, 17 and 19 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 6 recites the limitation "the central support" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 7 also repeats this limitation and is rejected as being dependent on claim 6.
Claim 9 recites the limitation "the central support" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the central support" in line 4. There is insufficient antecedent basis for this limitation in the claim. Claims 12 and 13 also repeat this limitation and are rejected as being dependent on claim 11.
Claim 13 recites the limitation "the hollow core" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "the perforated inlet plate" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation "the at least one cell culture element" in line 2. There is insufficient antecedent basis for this limitation in the claim. It is believed that the term should instead read “the at least one cell growth element”.
Claim 17 recites the limitation "the at least one cell culture element" in line 2. There is insufficient antecedent basis for this limitation in the claim. It is believed that the term should instead read “the at least one cell growth element”.
Claim 17 recites the limitation "the central support" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 19 recites the limitation "cell culture element" in line 2. There is insufficient antecedent basis for this limitation in the claim. It is believed that the term should instead read “cell growth element”.
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 1-8, 10 and 16-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stobbe (US 20140227769).
With respect to claim 1, Stobbe discloses a cell culture system comprising a bioreactor vessel having an interior void defining a cell culture space. An inlet and an outlet are fluidly connected to a first end and a second end of the cell culture space. Stobbe further teaches that at least one cell growth element is disposed in the cell culture space, wherein the cell growth element includes a cell culture substrate (Figure 4:41,43) surrounding a support element (Figure 4:42) extending in a direction from the first end to the second end. This is described in paragraphs [0376]-[0380].
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With respect to claim 2, Stobbe discloses the apparatus as described above. Stobbe describes that the cell culture substrates are sheets of material wrapped around the support element. See paragraph [0376].
With respect to claim 3, Stobbe discloses the apparatus as described above. Stobbe states in paragraph [0320] and provisional claim 19 that the cell culture substrate includes a woven substrate material comprising interwoven fibers with surfaces configured for adhering cells. See also paragraph [0020].
With respect to claims 4 and 5, Stobbe discloses the apparatus as described above. Stobbe further teaches in paragraphs [0102], [0142], [0159], [0163]-[0168], [0181] and [0217] that a plurality of cell growth elements (“capsules”; “modules”) are stacked to create an elongated column that extends in the direction from the first end to the second end. Stobbe states that the plurality of cell growth elements are removably attached to support different combinations. For example, paragraphs [0216]-[0220] state that the cell growth elements are stackable and disposable to support different combinations that perform different functions.
With respect to claims 6 and 7, Stobbe discloses the apparatus as described above. Stobbe teaches that the support element is configured as a central support that is tubular with a hollow core surrounded by a peripheral wall. The peripheral wall includes a plurality of perforations (Figure 4:42b) that connect an interior of the central support to an exterior of the central support. The central support is connected to the inlet and directs flow radially outward through the perforations, then through the cell culture substrate, and then through the outlet.
With respect to claims 8 and 10, Stobbe discloses the apparatus as described above. Stobbe further depicts an inlet plenum fluidly connected to and disposed between the inlet and the cell culture space. Similarly, an outlet plenum is fluidly connected to and disposed between the outlet and the cell culture space.
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With respect to claim 16, Stobbe discloses the apparatus as described above. Stobbe shows in Figs.4 and 5 that the cell growth elements have a cylindrical shape. This is also stated in paragraph [0097].
With respect to claim 17, Stobbe discloses the apparatus as described above. Stobbe discusses various attachment means in the form of seals, spacers and flanges to connect the cell culture substrates to the support element.
With respect to claim 18, Stobbe discloses the apparatus as described above. Stobbe further describes in paragraphs [0275]-[0305] a variety of examples in which the cell culture space may have a volume between 500 mL and 2.5 L.
With respect to claim 19, Stobbe discloses the apparatus as described above. Stobbe teaches in paragraph [0029] that there may be between 7 to 130 cell growth elements.
With respect to claim 20, Stobbe discloses the apparatus as described above. Stobbe states that the cell culture substrate may include a stack of material without any intervening solid material between adjacent layers. For example, Stobbe states that the substrate material may be packed layers of woven and/or non-woven fibers.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
Claims 9 and 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over Stobbe (US 20140227769) as applied to claims 8 and 10, and further in view of Amiot (US 5079168) and Feder (US 4201845).
Stobbe discloses the apparatus as described above, however does not expressly teach that the inlet and outlet are connected to the support element via a perforated inlet plate and a perforated outlet plate.
Amiot discloses a cell culture system comprising a bioreactor vessel having an interior void defining a cell culture space. At least one inlet (Figure 4:64,66,68) is connected to a first end of the cell culture space, and at least one outlet (Figure 4:74,78) is connected to a second end of the cell culture space. Fluid is supplied to a central support element (Figure 4:50) with a hollow cavity defining a manifold. A second end of the central support element is closed, and fluid is passed through a perforated plate (Figure 4:52) and into contact with cells growing on a rolled cell culture substrate (Figure 2:22,24). Plenum chambers (Figure 4:63,67,79) connect the inlets and outlets with the cell culture space.
Feder discloses a cell culture system comprising a bioreactor vessel having an interior void defining a cell culture space. At least one inlet (Figure 2:26,27) is connected to a first end of the cell culture space, and at least one outlet (Figure 2:28) is connected to a second end of the cell culture space. Fluid is passed from the inlet to a manifold, then through a perforated plate (Figure 2:35) and then to a cell culture substrate (Figure 2:34). Inlet (Figure 4:40) and outlet (Figure 4:41) perforated plates may be provided above and below the cell culture substrate.
Before the effective filing date of the claimed invention, it would have been obvious to modify the Stobbe system so that the inlet plenum is connected to the central support element via an inlet perforated plate, and so that the outlet plenum is connected to the central support element via an outlet perforated plate. Amiot and Feder demonstrate how fluidic manifolds and distribution plates are useful to uniformly deliver and remove fluid to a cell culture space in a controllable manner. Amiot and Feder further teach that perforated plates may additionally function to filter out contaminants from an inlet stream while preventing cells and cell components from escaping through the outlet stream. Manifolds and distribution plates systems may also function to retain a cell culture substate in place at a fixed location within the interior of the bioreactor vessel.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The Matsuo (US 5376548), Plitt (US 5585266), Amberg (US 3402103), Mairesse (US 12351793) and Meyers (US 4546083) references each the state of the art regarding bioreactor vessels comprising cell substrate and support elements.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN ANDREW BOWERS whose telephone number is (571)272-8613. The examiner can normally be reached M-F 7am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at (571) 272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NATHAN A BOWERS/Primary Examiner, Art Unit 1799