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 .
Response to Arguments
Applicant’s amendment filed 02/24/2026 is accepted and entered.
Applicant’s arguments with respect to claim(s) 1 and 18 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Claims 1 and 18 are now rejected based on Ilyin/Bitensky, as set forth below.
Applicant did not specifically argue the dependent claims.
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 1-3, 11, 13, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Ilyin (US 2018/0249703) in view of Bitensky et al (US 6162396).
Regarding Claim 1, Ilyin teaches a system (30, Figs. 2 and 4) for storing a blood product (¶ [0068]) comprising:
an inner container (conventional storage bag 32, Figs. 2 and 4) configured to contain the blood product (¶ [0068]), wherein the inner container (32, Figs. 2 and 4) is permeable to a gas system (¶ [0017, 0066, 0073]); and
an outer container (secondary bag 31, Figs. 2 and 4) including
a first end (end with seal 34, Figs. 2 and 4),
a second end (end labeled with 35, Figs. 2 and 4) opposite the first end (end with seal 34, Figs. 2 and 4),
a cavity defined between the first and second ends (¶ [0016, 0067]),
an inlet (33, Figs. 2 and 4) in fluid communication with the cavity (¶ [0016, 0067]), and
a valve operable to control a flow of the gas system through the inlet (33, Figs. 2 and 4; ¶ [0067]),
wherein the inner container (32, Figs. 2 and 4) is insertable into the cavity through the first end (end with seal 34, Figs. 2 and 4; ¶ [0067]),
wherein the first end (end with seal 34, Figs. 2 and 4) is sealable to hermetically seal the inner container (32, Figs. 2 and 4) within the cavity (¶ [0016-0017]),
wherein the outer container (31, Figs. 2 and 4) is made of first and second sheets of a material that is impermeable to the gas system (¶ [0014]; top surface of the bag, when laid flat, can be considered the first sheet with the bottom surface of the bag considered the second sheet), and
wherein the valve includes a sleeve made of the material (¶ [0067]; the gas inlet can include a sleeve, which would be made of the same material as the container to ensure the inlet/valve are also gas impermeable).
Ilyin is silent whether the material of the outer container comprises metal foil.
Bitensky teaches a blood storage device, thus being in the same field of endeavor, with an inner container (200, Fig. 1) within an outer container (100, Fig. 1), where the outer container (100, Fig. 1) comprises metal foil (Col. 6 lines 55-63) to provide the required gas impermeability for the outer container (Col. 6 lines 55-63).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the outer container of Ilyin to comprise metal foil, as taught by Bitensky, to provide the required gas impermeability for the outer container using known materials (as motivated by Bitensky Col. 6 lines 55-63).
Regarding Claim 2, Ilyin further discloses the sleeve extends into the cavity and includes a perforation, and wherein the gas system is configured to flow into the cavity through the sleeve and the perforation when a gas system source is connected to the inlet (33, Figs. 2 and 4; ¶ [0067]; the sleeve has an insertion point that can be considered the perforation).
Regarding Claim 3, Ilyin further discloses the sleeve is configured to collapse when a pressure within the cavity is greater than a pressure at the inlet (33, Figs. 2 and 4; ¶ [0067]).
Regarding Claim 11, Ilyin further discloses the gas system includes xenon (¶ [0066, 0073]).
Regarding Claim 13, Ilyin further discloses the valve is sealed inside the cavity when the first end (end with seal 34, Figs. 2 and 4) is sealed (¶ [0067]).
Regarding Claim 18, Ilyin discloses a method of storing a blood product (¶ [0068]), comprising:
inserting an inner container (32, Figs. 2 and 4) containing the blood product (¶ [0068]) into a cavity of an outer container (32, Figs. 2 and 4) through an open end (end with seal 34, Figs. 2 and 4; ¶ [0067]) of the outer container (31, Figs. 2 and 4), the inner container (32, Figs. 2 and 4) being permeable to a gas system and the outer container (31, Figs. 2 and 4) made of first and second sheets of a material that is impermeable to the gas system (¶ [0014]; top surface of the bag, when laid flat, can be considered the first sheet with the bottom surface of the bag considered the second sheet) made of first and second sheets of a material that is impermeable to the gas system (¶ [0014]; top surface of the bag, when laid flat, can be considered the first sheet with the bottom surface of the bag considered the second sheet) being made of first and second sheets of a material impermeable to the gas system (¶ [0014, 0017, 0066, 0073]; top surface of the bag, when laid flat, can be considered the first sheet with the bottom surface of the bag considered the second sheet),
opening a hole within the cavity (¶ [0067]; opening the valve within the cavity), the hole being formed in a body (gas inlet 33, Figs. 2 and 4 made of the material (¶ [0067]; the gas inlet can include a sleeve, which would be made of the same material as the container to ensure the inlet/valve are also gas impermeable);
introducing the gas system into the cavity through the hole (¶ [0067]); and
sealing the open end (34, Figs. 2 and 4) of the outer container (31, Figs. 2 and 4) to hermetically seal the inner container (32, Figs. 2 and 4) within the cavity of the outer container (31, Figs. 2 and 4; ¶ [0067]).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ilyin (US 2018/0249703) in view of Bitensky et al (US 6162396) further in view of Nakano et al (US 2020/0095056).
Regarding Claim 4, Ilyin further discloses the first sheet of material and the second sheet of material are sealed together at the second end (end labeled 35, Figs. 2 and 4).
Ilyin/Bitensky is silent whether the inlet extends through the second end.
Nakano teaches a bag system that can be used to hold blood, thus being in the same field of endeavor, where the outer container (pressure bag 1, Fig. 1) has an opening on the first end (11, Fig. 1) and an inlet (17, Fig. 1) extending through the second end (12, Fig. 1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the outer container of Ilyin/Bitensky to have the inlet extend through the second end, opposite of the first end of the bag, as taught by Nakano. Nakano indicates that this arrangement of the inlet and the opening of the outer container is well known in the art, and therefore one of ordinary skill in the art would recognize that placing the inlet on the opposite end of the bag of the opening would be obvious.
Claim(s) 5, 6, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Ilyin (US 2018/0249703) in view of Bitensky et al (US 6162396) further in view of Hanly et al (US 6726672).
Regarding Claims 5-6 and 9, Ilyin/Bitensky is silent whether the valve includes a flexible membrane and an orifice formed in the flexible membrane, wherein the membrane is configured to expand to open the orifice when a gas system source is connected to the inlet, wherein the valve includes external threads.
Hanly teaches a medical bag that can be used to store a blood product (Col. 1 lines 18-19), thus being in the same field of endeavor, with a valve (inlet port 204, Fig. 2) that includes a flexible membrane and an orifice formed in the flexible membrane, wherein the membrane is configured to expand to open the orifice when a connector is connected to the valve (204, Fig. 2; Col. 5 lines 3-17), and wherein the valve (204, Fig. 2) includes external threads (210, Fig. 2; Col. 5 lines 3-17). This allows the system to remain closed without the use of a separate cap (Col. 5 lines 3-17).
Therefore, it would have been obvious to modify the valve of Ilyin/Bitensky to include a flexible membrane and an orifice formed in the flexible membrane, wherein the membrane is configured to expand to open the orifice when a gas system source is connected to the inlet, wherein the valve includes external threads, as taught by Hanly, to allow the system to remain closed without the use of a separate cap (as motivated by Hanly Col. 5 lines 3-17).
Claim(s) 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Ilyin (US 2018/0249703) in view of Bitensky et al (US 6162396) further in view of Kuhn et al (US 2015/0298888).
Regarding Claims 7 and 8, Ilyin/Bitensky is silent whether the outer container includes a transparent window, wherein the inner container is visible through the transparent window when the inner container is hermetically sealed within the cavity.
Kuhn teaches a packaging for a medical container, thus being in the same field of endeavor, wherein the outer container (12, Fig. 2) includes a transparent window (18, Fig. 2; ¶ [0127]), wherein the inner container (13, Fig. 2) is visible through the transparent window (18, Fig. 2) when the inner container (13, Fig. 2) is hermetically sealed within the cavity (22, Fig. 2; ¶ [0027, 0127]). This allows the inner container to be examined without having to open the outer container (¶ [0027, 0127]).
Therefore, it would have been obvious to modify the outer container of Ilyin/Bitensky to include a transparent window, wherein the inner container is visible through the transparent window when the inner container is hermetically sealed within the cavity, as taught by Kuhn, to allow the inner container to be examined without having to open the outer container (as motivated by Kuhn ¶ [0027, 0127]).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ilyin (US 2018/0249703) in view of Bitensky et al (US 6162396) further in view of Sung (US 2015/0257975).
Regarding Claim 10, Ilyin/Bitensky is silent whether the first end of the outer container includes an interlocking closure.
Sung teaches an outer container for a medical container, thus being in the same field of endeavor, where the first end (20, Fig. 1) of the outer container (10, Fig. 1) includes an interlocking closure (¶ [0022]; the open edge has a reusable zipper seal). This allows the IV bag to be placed in to the outer container prior to sealing the open end with a resealable closure (¶ [0022]).
Therefore, it would have been obvious to modify the first end of the outer container of Ilyin/Bitensky to include an interlocking closure, as taught by Sung, to allow the IV bag to be placed in the outer container prior to sealing the open end with a resealable closure (as motivated by Sung ¶ [0022]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/JESSICA ARBLE/ Primary Examiner, Art Unit 3781