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
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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, 5, 10, 11, 15, 18, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 3397462 (Marchi hereinafter).
Regarding claim 1, Marchi teaches a tray assembly used in freeze-drying that discloses a tray configured to receive one or more containers each containing a liquid (Figures 1-4 show the tray made of 1/2/4 and Figure 4 specifically shows the containers within the tray); and a lid complementary to the tray and including one or more compressible members (Lid 8 with compressible members 9/10/11) configured to transition from an extended configuration to a compressed configuration in response to a downward force applied against the lid when the lid is positioned above the tray (Lid 8 as seen in Figures 3-5, where Figure 5 shows the closed state and Figure 3 shows the open state), wherein a gap exists between an upper edge of the tray and an underside of the lid when the one or more compressible members are in the extended configuration (Figure 4), and wherein the lid is sealed against the upper edge of the tray when the one or more compressible members are in the compressed configuration (Evident from Figure 5).
Regarding claim 2, Marchi’s teachings are described above in claim 1 where Marchi further discloses a gasket attached to the upper edge of the tray (Gasket 5).
Regarding claim 3, Marchi’s teachings are described above in claim 1 where Marchi further discloses that the tray includes one or more dividers configured to define two or more cavities within the tray, each of the cavities configured to receive at least one of the containers (Figure 1a with divider wall 3).
Regarding claim 5, Marchi’s teachings are described above in claim 1 where Marchi further discloses that each of the compressible members comprises a compressible leg member having a first portion and a second portion (First portion being the spring 11 and the second portion being the body 10), the first portion movable relative to the second portion (The spring compresses relative to the body 10).
Regarding claim 10, Marchi’s teachings are described above in claim 1 where Marchi further discloses that the tray and the lid comprise stainless steel (Column 5 Lines 23-26).
Regarding claim 11, Marchi’s teachings are described above in claim 1 where Marchi further discloses a vent port attached to the tray (Vent 6 in Figure 2).
Regarding claim 15, Marchi teaches a tray assembly used in freeze-drying that discloses at least one gas-impermeable container configured to receive a biological material (Vacuum Dry Apparatus in Figure 6 is viewed as a container to create the required vacuum environment); and a tray assembly configured to contain the at least one gas-impermeable container (Figures 1-4 show the tray made of 1/2/4 and Figure 4 specifically shows the containers within the tray), the tray assembly comprising: a tray configured to receive the at least one gas-impermeable container (Tray seen in Figures 1-4 as inserted into vacuum dry apparatus); and a lid complementary to the tray (Lid 8) and including one or more compressible members configured to transition from an extended configuration to a compressed configuration in response to a downward force applied against the lid when the lid is positioned above the tray (Compressible members 9/10/11 as evident from Figures 4-5), wherein a gap exists between an upper edge of the tray and an underside of the lid when the one or more compressible members are in the extended configuration (Figure 4), and wherein the lid is sealed against the upper edge of the tray when the one or more compressible members are in the compressed configuration (Figure 5).
Regarding claim 18, Marchi’s teachings are described above in claim 15 where Marchi further discloses that the tray assembly further comprises a vent port (Vent 6 in Figure 2).
Regarding claim 20, Marchi’s teachings are described above in claim 15 where Marchi further discloses that each of the one or more compressible members comprises a compressible leg member (Compressible leg interpreted with spring 11 and body 9).
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over US 3397462 (Marchi) in view of US 3811199 (Bouldoires hereinafter).
Regarding claim 4, Marchi’s teachings are described above in claim 3 but are silent with respect to the dividers are movable within the tray.
However, Bouldoires teaches a freeze-drying tray that discloses the use of a separating wall that is movable (Figure 4 with the plurality of removable dividers 25). The resultant combination would allow for the user to selectively use or not use the divider 3 of Marchi.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the tray of Marchi with the removable dividers of Bouldoires to allow for a user to size the tray area as desired while creating separate chambers/areas for differing containers.
Claims 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over US 3397462 (Marchi) in view of US 3736863 (Brucker hereinafter).
Regarding claim 6, Marchi’s teachings are described above in claim 5 but are silent with respect that the first portion comprises a telescoping detent pin member.
However, Brucker teaches a lid closing system that discloses a first portion of a compressible member that comprises a telescoping detent pin (Figures 1 and 5 with equivalent first portion 35 that features a telescopic pin per Column 2 Line 61 through Column 3 Line 29). The resultant combination would be such that the body 9 and spring 11 would be formed as a telescopic detent pin as shown in Brucker.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the pin assembly of Marchi with the telescopic pin of Brucker to enclose the spring assembly when the lid is removed and ensure that the spring and pin assembly remains in an assembled state.
Regarding claim 7, Marchi’s modified teachings are described above in claim 6 where the combination of Marchi and Brucker would further disclose that the second portion comprises a tube member configured to receive the telescoping detent pin member (Tube member 10 of Marchi as equivalent to 45 of Brucker).
Regarding claim 8, Marchi’s modified teachings are described above in claim 7 where the combination of Marchi and Brucker would further disclose that the tube member is attached to the underside of the lid (The second portion is indirectly connected to the lid via the first portion) and the telescoping detent pin member is configured to extend to an interior floor surface of the tray (Evident from Figures 3 and 4 of Marchi as modified by the telescopic pin structure of Brucker).
Regarding claim 9, Marchi’s modified teachings are described above in claim 8 where the combination of Marchi and Brucker would further disclose a support base of the telescoping detent pin member is configured to contact the interior floor surface of the tray (Support base being the portion of 9/11 of Marchi as modified to be 39/40 of Brucker and will be inContact with the tray floor per Figure 4 of Marchi).
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over US 3397462 (Marchi) in view of US 2019/0270680 (Mattei hereinafter).
Regarding claim 12, Marchi’s teachings are described above in claim 1 but are silent with respect that the tray has a length of about 20 inches to about 40 inches.
However, Mattei teaches a freeze drying system with a tray that is sized to be 12” by 18" which is about a length of 20” (¶ 19).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the size of the tray of Marchi with the sizing of Mattei to size the tray relative to the amount of targeted freeze dried material.
Regarding claim 13, Marchi’s teachings are described above in claim 1 but are silent with respect that the tray has a width of about 8 inches to about 20 inches.
However, Mattei teaches a freeze drying system with a tray that is sized to be 12” by 18" which has a width of about 8 inches to about 20 inches (¶ 19).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the size of the tray of Marchi with the sizing of Mattei to size the tray relative to the amount of targeted freeze dried material.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over US 3397462 (Marchi) in view of US 2005/0100604 (Shimizu hereinafter).
Regarding claim 14, Marchi’s teachings are described above in claim 1 but are silent with respect that the tray has a height of about 1 inch to about 5 inches.
However, Shimizu teaches a freeze-drying tray that discloses a tray that has a height of about 1 inch to about 5 inches (¶ 137 where the depth of 20 mm is about 1 inch).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the size of the tray of Marchi with the sizing of Shimizu to size the tray relative to the amount of targeted freeze dried material.
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over US 3397462 (Marchi) in view of US 2015/0354894 (Corbin hereinafter).
Regarding claim 16, Marchi’s teachings are described above in claim 15 but are silent with respect to a movable freeze-dryer shelf.
However, Corbin teaches a freeze drying system that discloses movable freeze-dryer shelf (Shelves 304 per ¶ 56-58 and Figures 3-4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the freeze drying system of Marchi with the assisting and moving shelves of Corbin to further ensure that the tray is sufficiency closed.
Regarding claim 17, Marchi’s modified teachings are described above in claim 16 where Corbin further discloses that the movable freeze-dryer shelf is configured to apply the downward force against the lid sufficient to seal the lid against the upper edge of the tray (Figures 3-4 with ¶ 56-58).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over US 3397462 (Marchi) in view of US 2017/0203871 (Murto hereinafter).
Regarding claim 19, Marchi’s teachings are described above in claim 15 but are silent with respect that the biological material comprises blood plasma.
However, Murto teaches a freeze dryer that discloses treating blood plasma (¶ 57).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the target material of Marchi with ability to freeze dry blood plasma to increase the number of targetable materials able to be used in Marchi.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CONNOR J. TREMARCHE whose telephone number is (571)272-2175. The examiner can normally be reached Monday - Thursday 0700-1700 Eastern.
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/CONNOR J TREMARCHE/Primary Examiner, Art Unit 3762
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