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 3 and 10 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 3 recites the limitation "the molded shelf" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. The “shelf” in claim 2 is not identified as being “molded”.
Claim 10 recites a limitation relating to a “ring-shaped foil cutter” that is not an element of the “tray assembly” set forth in claim 1. The specification identifies that the ring-shaped foil cutter 160 (see Fig. 4) is a feature that is usable with, but distinct from, the tray assembly 700 (see Fig. 7). Therefore, it is unclear how the foil cutter of claim 10 is said to be a component of the tray assembly set forth in the preamble of independent claim 1.
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, 2, 6-9, 11, 12, 17 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Olivier (US 20180328823).
With respect to claim 1, Olivier discloses a tray assembly for a cassette assembly comprising a tray (Figure 3B:3) configured to receive an oxygen-scavenging material (Figure 1C:23). A seal (Figure 1A:4) is configured to create an airtight seal on one side of the tray. The tray is covered by a lid (Figure 6:26) that is positioned over an open top, which functions as a fill port to receive the oxygen-scavenging material 23. This is described in paragraphs [0045]-[0049].
With respect to claim 2, Olivier discloses the apparatus as described above. Olivier further states that a shelf is configured to be disposed within the tray.
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With respect to claims 6, 7 and 9, Olivier discloses the apparatus as described above. Oliver shows that the tray is “C”-shaped, and that the open top may be filled at ports at each end of the “C” shape. As discussed above, the cover 26 provides an air-tight seal when disposed above the fill ports.
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With respect to claim 8, Olivier discloses the apparatus as described above. Olivier shows in Fig. 2 that the tray 3 substantially surrounds an internal testing environment 3 of the cassette assembly.
With respect to claim 11, Olivier discloses the apparatus as described above. Olivier teaches a corresponding method in which the tray is filled with oxygen-scavenging material 23 through the one or more fill ports (Fig. 1C) and a seal is applied to the tray via movement of a tap device 4.
With respect to claim 12, Olivier discloses the method as described above. Olivier further states that a shelf is deployed inside the tray (see rejection of claim 2).
With respect to claims 17 and 18, Olivier discloses the method as described above. Oliver shows that tray may be subdivided 3a, 3b, and that each subunit includes an open top comprising a fill port. As discussed above, the cover 26 provides an air-tight seal when disposed above the fill ports.
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 3 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Olivier (US 20180328823) as applied to claims 1 and 11, and further in view of Brewer (US 5034331).
Olivier discloses the apparatus and method in claims 1 and 11, however does not teach that a foam insert used to prevent oxygen-scavenging material from exiting the tray.
Brewer discloses a tray assembly configured to receive an oxygen-scavenging material. The oxygen-scavenging material is a metal hydrosulfite that is dispersed in a gel composition (Figure 1:20) configured as a foam. The foam gel composition 20 immobilizes the oxygen-scavenging material in the headspace above a cell culture medium (Figure 1:16).
Before the effective filing date of the claimed invention, it would have been obvious to modify Olivier to include a foam insert configured to prevent oxygen-scavenging material from exiting the tray when the seal is broken. Brewer teaches that oxygen-scavenging materials are desirably dispersed in a gel/foam composition to position the oxygen-scavenging materials in communication with cell culture gases, but not directly in communication with the culture liquid. Those of ordinary skill would understand that this would remove oxygen from the culture headspace to promote anaerobic conditions while preventing direct contamination of the culture fluid with toxic materials.
Claims 4, 5, 14-16, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Olivier (US 20180328823) as applied to claims 1 and 11, and further in view of Beall (US 4347222).
Olivier discloses the apparatus and method as described above, however does not teach that the seal is a foil that is punctured by a cutting subassembly.
Beall discloses a tray assembly (Figure 1:10) configured to receive an oxygen-scavenging material (Figure 4:48) that is activated when a seal (Figure 4:47 and Figure 3:46) is ruptured by a cutter (Figure 3:55). This is described in column 3, line 10 to column 4, line 14. Beall states that the seal is formed within the tray assembly using heat sealing techniques. Heat welding and adhesives are considered to be functionally equivalent and interchangeable sealing mechanisms.
Before the effective filing date of the claimed invention, it would have been obvious to provide the Olivier tray assembly with an alternative sealing/cutting means, such as a foil that is punctured by a cutter. Beall teaches that this is an effective way to expose oxygen-removing agent to an enclosed cassette environment at a desired time in a controllable manner. Beall teaches that a foil may be “conveniently formed” using simple techniques, and that the seal is readily broken by a user when desired by pushing the cutter into contact with the foil.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The Mackin (US 3248302) reference teaches the state of the art regarding oxygen-scavenging materials contained within a frangible seal of a cassette assembly.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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