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, 4, 10, 13, 14 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Seal (US 20160303567).
With respect to claims 1, 14 and 20, Seal discloses a system and method for transporting and installing a flexible bioprocessing vessel. The flexible bioprocessing vessel may be a bag, which is typically formed by welding the perimeter of a top flexible panel to the perimeter of a bottom flexible panel. In at least one example, the bag may include a top panel (Figure 8:101), a bottom panel (Figure 8:102), and multiple side panels (Figure 8:103, 104, 105, 106). A base portion (Figure 1:10) of a support apparatus (Figure 1:1000) is operatively connected to the bottom panel of the flexible bioprocessing vessel (Figure 9:100). The base portion includes a first wing portion (Figure 1:11A) and a second wing portion (Figure 1:12A) that are selectively movable relative to the base portion between a first position and a second position. A top plate (Figure 5:210) of the support is operatively connected to the top panel of the flexible bioprocessing vessel 100 and remains attached to the top panel during use. A front panel (Figure 1:13) is connected to a front end of the base portion and includes a plurality of apertures (see Figs. 1 and 9) configured to secure and protect tubing and/or connectors extending from the flexible bioprocessing vessel. When the wings are in a first position (see Figs. 6, 7, 9 and 10), they are operatively connected to first and second sides of the top plate to form a storage cavity for the flexible bioprocessing vessel. When the wings are in a second position, (see Figs. 1 and 2), they are disconnected from the first and second side of the top plate. This is taught in paragraphs [0025]-[0039]. The support apparatus 1000 carrying the flexible bioprocessing vessel 100 may be transported to a desired location and installed within a rigid support structure (Figure 4:500).
With respect to claim 4, Seal discloses the apparatus as described above. Seal further teaches that the first and second wing portions each including a handle (Figure 2:121,122).
With respect to claim 10, Seal discloses the apparatus as described above. Seal further indicates that the top plate 210 includes a tube support (Figure 9:200) configured to receive tubing of the flexible bioprocessing vessel.
With respect to claim 13, Seal discloses the apparatus as described above. The support apparatus of Seal is fully capable of transporting and installing a variety of different flexible bioprocessing vessels, including those that have at least 8 panels. It is noted that the “flexible bioprocessing vessel” is not positively recited in independent claim 1, which is specifically drawn to the support apparatus. The flexible bioprocessing vessel is not a feature of the support apparatus, but rather is placed inside the support apparatus during use.
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 2, 15 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Seal (US 20160303567) as applied to claims 1, 14 and 20, and further in view of Becker (US 20220235304) and/or Heeren (US 20250144584).
Seal discloses the system and method described above, however does not expressly teach a selectively removable base.
Becker discloses a system and method for transporting and installing a flexible bioprocessing vessel. A support apparatus (Figure 3:12) comprising a selectively removable support base (Figure 3:14) is provided to support a flexible bioprocessing vessel. Portions of the flexible bioprocessing vessel that extend through a recess (Figure 3:30) disposed in the base panel of the support apparatus are protected by the selectively removable support base 14, given that the legs (Figure 3:16) of the selectively removable support base elevate the assembly.
Heeren discloses a system and method for transporting and installing a flexible bioprocessing vessel. A support apparatus (Figure 15:700) comprising a selectively removable support base (Figure 15:702) is provided to support a flexible bioprocessing vessel. Paragraphs [0082]-[0084] state that portions of the flexible bioprocessing vessel that extend through a base panel of the support apparatus are protected by the selectively removable support base 702 (“at least one selectively removably tray 702 configured for connection to an exterior of the base portion to protect, for example, the drain hose and/or a downwardly protruding portion of the impeller seat and provide storage during shipping while the apparatus 700 is in an external box (not shown”).
Before the effective filing date of the claimed invention, it would have been obvious to provide the support apparatus of Seal with a selectively removable support base. Becker teaches that such a structure may include legs that allow the flexible bioprocessing vessel and support assembly to be transported and moved, for example, through the addition of wheels. The selectively removable support base may additionally include legs which elevate the flexible bioprocessing vessel and thereby protect any portions (e.g., tubes, motor) of the assembly that extend through the apparatus during transport. Heeren directly states that there is a need to protect drain hose and impeller structures that extend past the base plate of the support apparatus, and that the provision of a selectively removable tray is a solution to this problem that facilities transport and installation.
Claims 3, 5, 6, 11, 12, 16-19, 21 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Seal (US 20160303567) as applied to claims 1 and 14.
With respect to claims 3, 5, 6, 16-19 and 23, it is well established that a mere rearrangement of parts, such as changing the location of slots and handles, that does not substantially affect device operation is considered to be prima facie obvious. See MPEP 2144.04. Similarly, design changes, including those regarding the shape of the bioprocessing vessel and base portion, that do not substantially affect device operation are also considered to be prima facie obvious. See MPEP 2144.04. Indeed, Seal recognizes that the vessel and support apparatus may be configured according to a variety of different forms and shapes (“A bioreactor bag can have any suitable form (e.g., cylindrical (having, for example, a single continuous side wall), square, or rectangular)”).
With respect to claim 11, Seal discloses a beam (Figure 9:200) attached to the top plate (Figure 9:210) for facilitating the extension of tubing through the top plate. Although Seal does not expressly state that the beam is removable, it is noted that making a prior art feature separable is generally considered to be prima facie obvious, especially in the absence of a showing of criticality explaining why the distinction between removable/integral features is important. See MPEP 2144.04.
With respect to claim 12, Seal teaches that the flexible bioprocessing vessel may have a volume of at least about 1,000 L or greater. See paragraph [0023]. Those of ordinary skill would therefore have considered to use the Seal support apparatus to handle 2,000L flexible bioprocessing vessels.
With respect to claim 21, Seal discloses that the support apparatus is placed within a rigid support structure (Figure 4:500). Although not expressly stated, those of ordinary skill would have found it obvious to detach the top plate and perform a cell culture operation (“deploying the flexible bioprocessing vessel”) while disposed within the rigid support structure. This is due to the fact that Seal’s stated goal is to use the support apparatus to facilitate the transport of a large flexible bioprocessing vessel to a processing site and then set up the bioprocessing operation at that processing site.
Claims 7-9 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Seal (US 20160303567) as applied to claims 1, 14 and 20, and further in view of Brown (US 20160095279).
Seal discloses the system and method described above. As previously discussed, Seal teaches the use of handles and first and second wings that function as side panels. Seal, however, does not teach removeable side panels configured to interface with the wing portions.
Brown discloses an apparatus for transporting and installing a flexible bioprocessing vessel (Figure 6:68). The apparatus includes a base portion (Figure 4:26) and removable side panels (Figure 5:30A,B). This is described in paragraphs [0039]-[0044]. Paragraph [0070] describes the use of cable ties to connect portions of the support assembly.
Before the effective filing date of the claimed invention, it would have been obvious to connect the first and second wing portions of Seal to the top plate using removable side panels. Brown indicates that removable side panels are simple to construct and operate in a predictable manner. Brown states that they include fasteners 104 to enable a modular assembly of the support apparatus and connection to the flexible bioprocessing vessel. Brown shows that those of ordinary skill would have recognized integral side panels and removable side panels to be functionally equivalent and interchangeable options (“However, in contrast to the sidewalls being connected together by a single continuous floor 26 extending therebetween, each sidewall 30A and 30B has a separate floor portion 56A and B, respectively, from which sidewalls 30A and 30B upstand”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The Forsberg (US 11535421), Barrett (US 20130157355), Barbaroux (US 20110044567), KR 102041088 and Runyon (US 20100316446) references disclose the state of the art regarding support apparatuses for bioprocessing vessels.
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
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