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 .
Election/Restrictions
Claim(s) 5, 6, and 14-20 which are stated that they have been withdrawn due to a restriction requirement has only the claim number and the status indicator of the claim (Withdrawn). However, this format is not an acceptable format, only cancelled claims can be listed with a claim number and a status indicator of cancelled and withdrawn claims must still have the text of the claim (MPEP § 714 (II)(C)(A)). The applicant is requested to send a correct listing of the claims with the next submission with either claim(s) 5, 6, and 14-20 being cancelled or the text of claim(s) 5, 6, and 14-20 present with a status indicator of withdrawn.
Response to Amendment
The amendments and remarks, filed on 3/16/2026, has been entered. The claim amendments overcome the previous 112(b) rejection of claim 12.
The amendments and remarks, filed on 3/16/2026, has been entered. The claim amendments overcome the previous prior art rejection, and a new prior art rejection is applied to address the claim amendments.
Claim Status
Claims 1-20 are pending with claims 1-4 and 7-13 being examined and claims 5, 6, and 14-20 are withdrawn.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-4 and 7-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tanaka et al (US 20090258417 A1; hereinafter “Tanaka”; already of record on IDS filed 8/11/2025) in view of Juncosa et al (US 6225109 B1; hereinafter “Juncosa”).
Regarding claim 1, Tanaka teaches a bioprocess bag for containing a bioprocess fluid (Tanaka; Abstract; culture vessel), comprising:
a frame having a first opening and a second opening (Tanaka; Fig. 1A, 1B; para [20]; A frame 2 is made by injection molding or other method and consists of long sides 3, short sides 4 and a window portion 5; the examiner interprets the top plane of the frame as the first opening and the bottom plane of the frame as the second opening),
a first layer of film bonded to the frame to cover the first opening (Tanaka; Fig. 1A, 1B; para [20]; On the front and back sides of the frame 2, there are formed, by a suitable means, gas permeable films 5, 5 face to face with a predetermined interval between them in the direction of thickness of the frame 2), and
a second layer of film bonded to the frame to cover the second opening (Tanaka; Fig. 1A, 1B; para [20]; On the front and back sides of the frame 2, there are formed, by a suitable means, gas permeable films 5, 5 face to face with a predetermined interval between them in the direction of thickness of the frame 2; examiner notes there are two permeable films),
wherein the frame, the first layer of film, and the second layer of film form an enclosed space for containing the bioprocess fluid (Tanaka; Fig. 1; para [23]; the gas permeable films 5, 5 formed on the front and back sides of the frame 2 constitutes a space for filling contents liquid therein and the capacity of this space 6),
the frame being disposed between the first layer of film and the second layer of film (Tanaka; Fig. 1A, 1B).
Tanaka does not teach wherein the frame includes an interlocking mechanism; and a cap, wherein the interlocking mechanism of the frame is configured to interlock a corresponding interlocking mechanism of the cap, and wherein the cap is configured to cover the first layer of film.
However, Juncosa teaches an analogous art of an assay device (Daep; para [6]) comprising a frame (Juncosa; Fig. 3; col 4, lines 52; a rear member 12), wherein the frame includes an interlocking mechanism (Juncosa; Fig. 3; col 4, lines 52- 56; the members 11 and 12 are preferably made from a plastic material, such as polyurethane, polycarbonate, or polystyrene, and are held tightly together by snap fit closure members 13, 14) and a cap (Juncosa; Fig. 3; col 4, lines 51; front member 11) wherein the interlocking mechanism of the frame is configured to interlock a corresponding interlocking mechanism of the cap (Juncosa; Fig. 3; col 4, lines 52- 56; the members 11 and 12 are preferably made from a plastic material, such as polyurethane, polycarbonate, or polystyrene, and are held tightly together by snap fit closure members 13, 14) and wherein the cap is configured to cover the first layer of film (Juncosa; Figs 1, 2; col 5, lines 21-25; elongated ribs 18 and 19 on front housing member 11 and wide raised rib member 20 on the rear housing member 12, compress the middle layer and hold the glass slide 16 and middle layer 15 tightly in place). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the frame of Tanaka to comprise interlocking mechanism taught by Juncosa, because Juncosa teaches that closure member snap fits with the front member which is interpreted as the cap (Juncosa; col 4, lines 52- 56). Further, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the bag of Tanaka to comprise cap taught by Juncosa, because Juncosa teaches that the cover secures the middle structures (Juncosa; col 5, lines 23-26).
Regarding claim 2, modified Tanaka teaches the bag of claim 1, wherein the frame, the first layer of film, and the second layer of film are made of a same material or compatible materials (Tanaka; para [23, 39, 40, 41]; the gas permeable films 5, 5). Tanaka teaches where the gas permeable films for each example are made of the same material.
Regarding claim 3, modified Tanaka teaches the bag of claim 1, wherein the frame, the first layer of film, and the second layer of film are made of fluoropolymer (Tanaka; para [27, 28]; a monolayer or multilayer film consisting principally of a polyolefin resin or a fluoroplastic may preferably be used… fluoroplastic such as tetrafluoride ethylene-hexafluoride propylene copolymer).
Regarding claim 4, modified Tanaka teaches the bag of claim 1, wherein the first layer of film is a single layer film, and the second layer of film is a single layer film (Tanaka; para [41]; frame made of polystyrene (PS) was used and, as shown in Table 1, the gas permeable films of the culture vessel were made of a PS film having thickness of 100 μm). Tanka teaches that the gas permeable film is made of as single material/single layer film.
Regarding claim 7, modified Tanaka teaches the bag of claim 1, wherein a minimum thickness of the first layer of film or the second layer of film is at or about three thousandth of an inch (Tanaka; para 39, 40, 41, 42]). Tanaka teaches the gas permeable layers comprising different materials with a thickness of about 100 μm. The examiner notes that the minimum thickness of about three thousandth of an inch is 76.2 μm, and Tanaka teaches that the thickness not being less than the minimum requirement.
Regarding claim 8, modified Tanaka teaches the bag of claim 1, wherein a maximum thickness of the first layer of film or the second layer of film is at or about 25 thousandth of an inch (Tanaka; para 39, 40, 41, 42]). Tanaka teaches the gas permeable layers comprising different materials with a thickness of about 100 μm. The examiner notes that a thickness of about 25 thousandth of an inch is 635 μm, and Tanaka teaches that the thickness not being greater than the maximum requirement.
Regarding claim 9, modified Tanaka teaches the bag of claim 1, further comprising: at least one fitting, wherein the at least one fitting is configured to fill the bag with the bioprocess fluids or drain the bioprocess fluids from the bag (Tanaka; para [24]; A contents liquid filling tube 7 and a tube 8 for taking out contents liquid are attached to one long side 3a of the long sides 3 of the frame 2).
Regarding claim 10, modified Tanaka teaches the bag of claim 9, wherein the at least one fitting and the frame are integrally formed using injection molding (Tanaka; para [20]; A frame 2 is made by injection molding or other method and consists of long sides 3, short sides 4 and a window portion 5). While Tanaka does not explicitly teach that the fitting and the frame are integrally formed using injection molding, this is a process limitation in a product claim. The patentability of a product is independent of how it was made. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). The burden is on applicants to show product differences in product by process claims.
Regarding claim 11, modified Tanaka teaches the bag of claim 9, further comprising: a cap having at least one fitting cover, wherein the at least one fitting cover is configured to protect the at least one fitting (Tanaka; para [24]; Contents liquid which is a mixed liquid of a cell and a culture medium is filled from the contents liquid filling tube 7 into the vessel 1 and the vessel 1 is sealed with a suitable known means). Tanaka teaches filling the vessel and then sealing the tubes with a known means.
Regarding claim 12, modified Tanaka teaches the bag of claim 1, wherein the interlocking mechanism of the frame and the interlocking mechanism of the cover are configured to interlock with each other using snap-fit (Juncosa; Fig. 3; col 4, lines 52- 56; the members 11 and 12 are preferably made from a plastic material, such as polyurethane, polycarbonate, or polystyrene, and are held tightly together by snap fit closure members 13, 14).
Regarding claim 13, modified Tanaka teaches the bag of claim 12 (the bag of Tanaka is modified to comprise the cap as taught by Juncosa as discussed above in claim 12), wherein the cap is configured to cover the first layer of film that covers the first opening or the second layer of film that covers the second opening of the frame (Tanaka; Fig. 1A, 1B; para [20]; On the front and back sides of the frame 2, there are formed, by a suitable means, gas permeable films 5, 5 face to face with a predetermined interval between them in the direction of thickness of the frame 2; Juncosa; Figs 1, 2; col 5, lines 21-25; elongated ribs 18 and 19 on front housing member 11 and wide raised rib member 20 on the rear housing member 12, compress the middle layer and hold the glass slide 16 and middle layer 15 tightly in place). The bag of Tanaka is modified to comprise the cap which engages with the base, equivalent to the frame of Tanka, to secure the film/layer positioned on the first opening.
Response to Arguments
Applicant’s arguments filed, 3/16/2026, have been considered and some of the arguments are found to be persuasive. However, those arguments are directed towards the claim amendments. The examiner notes that the previous prior art rejection is withdrawn and a new prior art rejection is applied to address the claim amendments.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Austin Q Le whose telephone number is (571)272-7556. The examiner can normally be reached Monday - Friday 9am - 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Curtis Mayes can be reached at (571) 272-1234. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.Q.L./Examiner, Art Unit 1796
/MATTHEW D KRCHA/Primary Examiner, Art Unit 1796
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