DETAILED ACTION
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.
Claim 10 is 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 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 a bottom side (“first side”) of the tray, such that the seal may be used to block a communication path (Figure 3C:8). 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. The fill port covered by the lid is disposed on a top side (“second side”) of the tray that is opposite the bottom side. This is described in paragraphs [0045]-[0049].
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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.
Response to Arguments
Applicant's arguments filed 05 August 2026 have been fully considered but they are not persuasive.
Applicant argues that claim 10 is not indefinite because paragraph [0029] of the specification states that the try assembly may also include a ring-shaped foil cutter configured to penetrate the seal. However, the specification repeatedly refers to the cutter and the tray assembly as distinct and separate features, such that the cutter is not a component of the tray assembly. Paragraphs [0047]-[0050] and [0089]-[0096] describe the assembled tray assembly 700. Although the cutter 106 is said to interact with the foil seal 604 of the tray assembly 700, the cutter is described as an independent unit. The assembled tray assembly 700 is shown in Fig. 7 without the cutter depicted as a sub element. The assembled tray assembly 700 is shown in Figs. 8 and 9 without the cutter depicted as a sub element. The assembled tray assembly 700 is shown in Fig. 10 without the cutter depicted as a sub element. The cutter 106 is independently shown in Figs. 4-5d without reference to the tray assembly. Indeed, the cutter 106 and tray assembly 700 are organized as sub elements of the cassette assembly 100. See Fig. 1. It is consistent with the specification to state that
The cassette assembly 100 comprises
lid 102
[AltContent: rect]cutter 106
[AltContent: textbox (Subject matter of the
instant claims)][AltContent: arrow]tray assembly 700
tray
seal
fill ports
Etc. (mid body assembly, base assembly)
It is inconsistent with the specification to state that
The cassette assembly 100 comprises
lid 102
tray assembly 700
cutter
tray
seal
fill ports
Etc. (mid body assembly, base assembly)
Applicant argues that the Olivier fill port and seal are disposed on the same side of the tray, as opposed to oppositely arranged first and second sides. This does not appear to be correct because Olivier teaches that the seal (Figure 1A:4) is configured to create an airtight seal on a bottom side (“first side”) of the tray, such that the seal may be used to block a communication path (Figure 3C:8). 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. The fill port covered by the lid is disposed on a top side (“second side”) of the tray that is opposite the bottom side. This is described in paragraphs [0045]-[0049].
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Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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