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 § 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 1-3, 8-10, 21-24 and 27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Larsen (US 20130081995).
With respect to claims 1 and 21, Larsen discloses a cell separation device configured for separating cells from microcarriers or spheroids in a liquid. The device includes a vessel (Figure 11:320) comprising a first port (Figure 11:150), a second port (Figure 11:156) and a cavity (Figure 11:126). A porous mesh (Figure 11:322) is disposed within the cavity to divide the cavity into a first compartment and a second compartment, wherein the first port is in communication with the first compartment of the cavity and a first side (Figure 11:328) of the porous mesh, and wherein the second port is in communication with the second compartment of the cavity and a second side (Figure 11:330) of the porous mesh. Figures 11-12C show that the porous mesh is positioned within the cavity to have an inclined orientation relative to fluid flow, and Figure 13 shows another embodiment in which the porous mesh (Figure 13:352) has a substantially vertical orientation.
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With respect to claims 2 and 23, Larsen discloses the apparatus as described above. Larsen further shows in at least Fig. 11 that the first port 150 is located at one end (i.e., top end) of the vessel, and that the second port 156 is located at an opposing end (i.e., bottom end) of the vessel.
With respect to claims 3 and 24, Larsen discloses the apparatus as described above. Larsen shows in Fig. 13 that the first port and second port are vertically and horizontally offset from each other, and that the porous mesh has a substantially vertical orientation within the cavity. As previously noted, the first port is located at a top end of the vessel and therefore is located in a substantially upward orientation, and the second port is located at a bottom end of the vessel and therefore is located in a substantially downward orientation.
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With respect to claims 8 and 27, Larsen discloses the apparatus as described above. Larsen further teaches in paragraph [0061] that the porous mesh includes pores having a size between about 15 microns to 100 microns.
With respect to claim 9, Larsen discloses the apparatus as described above. Larsen further indicates that the vessel is supported within an outer housing (Figure 11:210) that surrounds the vessel.
With respect to claim 10, Larsen discloses the apparatus as described above. Larsen shows that the vessel is coupled to a ring stand (Figure 5:262) comprising wheels that facilitate movement and rotation of the vessel.
With respect to claim 22, Larsen discloses the apparatus as described above. The cell separation of Larsen may be used in operations in which the viability of collected cells is at least 98.1%. The device of Larsen is structurally identical to that of the claimed invention, and therefore a presumption exists that it is characterized by the same operation and is capable of yielding equivalent results. Larsen does not mention any occurrence of cell death or describe any difficulty in maintaining cell viability. Furthermore, it is well established that apparatus claims cover what a device is, not what a device does. A claim containing 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 if the prior art apparatus teaches all the structural limitations of the claim. See MPEP 2114.
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 4, 5, 25 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Larsen (US 20130081995) as applied to claims 1 and 21.
Larsen discloses the apparatus as described above. Although Larsen does not appear to expressly show an embodiment in which the first and second port are in-line with each other or an embodiment in which the first and second port are both positioned on the same side of the vessel, Larsen does state in paragraph [0058] that inlet and outlet ports “can also be located at different locations on body 120 such as side wall 128”. Larsen, therefore, clearly authorizes one to consider other locations for the inlet and outlet ports than those depicted in the Figures. Those of ordinary skill would have recognized that configuring the first port so that it is in-line with the second port would not substantially affect device operation.
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Similarly, those of ordinary skill would have understood that configuring the first and second port so that they are both positioned on one side of the vessel in a substantially downward (or upward) orientation would not substantially affect device operation. A mere rearrangement of parts that does not change the basic function of a system or apparatus is generally considered to be prima facie obvious. See MPEP 2144.04.
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Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Larsen (US 20130081995) as applied to claim 1, and further in view of Chang (US 7033823).
With respect to claim 6, Larsen discloses the apparatus as described above, however does not expressly state that a first cap and second cap are attached to the first and second ports, respectively.
Chang discloses a cell culture device comprising a vessel (see Figure 8) comprising a first port (Figure 8:840) and a second port (Figure 8:840’). Cells are retained on a scaffold (Figure 8:820) disposed within the vessel, while culture fluid is allowed to perfuse through the first port, into the vessel, and out the second port. This is described in at least column 25, lines 45-67 (“at least one opening 840 for loading or withdrawing cells and/or culture medium into or out of culture chamber”). Column 16, lines 16-24 state that a first cap (Figure 8:850) is attached to the first port and that a second cap (Figure 8:850’) is attached to the second port.
Before the effective filing date of the claimed invention, it would have been obvious to cover the inlet and outlet ports of Larsen with first and second caps. Those of ordinary skill would have understood that this would protect against contamination and fluid loss when the Larsen vessel to be disconnected from the inlet and outlet fluidic circuits. Chang indicates that screw caps and snap caps are inexpensive and readily purchased and/or constructed from known plastic materials. Chang further describes how caps may be easily fitted with sterilizing air filters.
With respect to claim 7, Larsen discloses the apparatus as described above. Larsen additionally shows in at least Fig. 1 how the cell separation device is in communication with a bioreactor and a perfusate collection system (i.e., recycling detached cells and/or collecting a cellular product). Accordingly, Larsen strongly implies that a first flow control system regulates flow into the cell separation device through the first port and that a second flow control system regulates flow out of the cell separation device through the second port. Larsen, however, does not appear to expressly disclose these flow control systems.
Chang discloses that a first flow control system comprising a pump (Figure 17A:1743) and fluid line direct a fluid into the cell vessel (Figure 17A:1710) through a first port from a storage container (Figure 17A:1741). A second flow control system comprising a pump (Figure 17A:1744) and fluid line direct fluid out of the cell vessel from a second port and into another storage container (Figure 17A:1742). This is taught in column 28, line 49 to column 29, line 12. At least one controller (Figure 17B:1748) regulates the operation of the pumps and valves (Figure 16:1643,1644).
Before the effective filing date of the claimed invention, it would have been obvious to ensure that the Larsen cell separation device includes a first flow control system and a second flow control system. Chang teaches that flow conduits, pumps, valves and controllers are necessary for regulating the movement of fluid through a cell processing vessel. These operations are easily automated using known computer control systems.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The Hori (US 20060054557) reference discloses the state of the art regarding membrane separation systems.
The Hatanaka (US 20220041971) reference discloses a similar separation device, but it is not prior art.
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