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
Claims 21, 23-25, 27, and 31-34 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/3/2024.
The amendments (current and previous) to claim 21 (and thus its dependents as well) further define the invention in a manner that is directed solely to the embodiment shown in Figures 6-10 (loading opening adjacent to the center seam), an embodiment which was not elected in the 9/3/2024 restriction response. Claims 21+ are no longer generic or directed to the elected embodiment of Figures 1-5 and are therefore withdrawn.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 (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.
Claim(s) 14, 15, and 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hill (US 5024536) in view of Lerner et al. (US 2006/0262997, hereinafter ‘Lerner’) and Yanase (US 4634006).
Hill discloses a multi-chamber container assembly, comprising: a first layer (3); a second layer (5), the second layer being separate from the first layer (Figs. 4-9); a plurality of seals (7, 8, 9) coupling the first layer to the second layer to define at least a first storage volume of a first separable flexible container and a second storage volume of a second separable flexible container adjacent to the first separable flexible container (left side compartments in Figs. 5-9), each of the first separable flexible container and the second separable flexible container has a first end portion, a second end portion, and a pair of side edges extending between the first end portion and the second end portion (see Figs. 4-9), the first end portion of the first separable flexible container is coupled to the first end portion of the second separable flexible container (see Figs. 4-5); a hinge (8) portion of the first layer and the second layer defined by a center seam/longitudinal axis of the plurality of seals positioned between the first end portion of the first separable flexible container and the first end portion of the second separable flexible container (see Figs. 4-5), the first end portion of the first separable flexible container being between the hinge portion and the second end portion of the first flexible separable container, the first end portion of the second separable flexible container being between the hinge portion and the second end portion of the second flexible separable container (see Figs. 4, 5), wherein: each of the first separable flexible container and the second flexible container are configured to be transitioned from an initial-empty configuration to a filled configuration and from the filled configuration to an opened configuration (functional recitation), the first end portion of the first separable flexible container defines a first opening (@11) sized to receive a first biological material on a condition that the first separable flexible container is in the initial-empty configuration and is configured to be sealed on a transition of first separable flexible container from the initial-empty configuration to the filled configuration (functional recitation), the first end portion of the second separable flexible container defines a second opening (@11) sized to receive a second biological material on a condition that the second separable flexible container is in the initial-empty configuration and is configured to be sealed on a transition of second separable flexible container from the initial-empty configuration to the filled configuration (functional recitation), and the first opening, the second opening, and the center seam are parallel to one another (Figs. 4, 5); except does not expressly disclose the frangible region or destructive opening regions and associated opening as claimed.
However, Lerner teaches constructing separable multi-compartment packaging wherein all adjacent packaging edges include a frangible region (35, 36) configured for separation of the first separable flexible container from the second separable flexible container.
At the time of the invention, it would have been obvious to a person having ordinary skill in the art to add the perforations taught by Lerner to the packaging taught by Hill, in order to facilitate compartment separation as taught by Lerner (para 0039).
Further, Yanase teaches providing connected separable flexible containers the first end portion of the first separable flexible container defines a first destructive opening region (@96) configured to transition the first separable flexible container from a filled configuration to an opened configuration (once torn open) and the first end portion of the second separable flexible container defines a second destructive opening region (@96) configured to transition the second separable flexible container from a filled configuration to an opened configuration (once torn open) as claimed.
At the time of the invention, it would have been obvious to a person having ordinary skill in the art to add the destructive opening regions/notches taught by Yanase to the first ends of the packaging taught by Hill as modified above, in order to facilitate opening the compartments from either end as taught by Yanase (col. 9, ll. 32-54).
Hill as modified above further results in a device wherein the first destructive opening region facilitates access to a stored product within the first separable flexible container without affecting a hermetic sealing of the second separable flexible container (functional recitation); a third separable flexible container, the third separable flexible container has a first end portion, a second end portion, and a pair of side edges extending between the first end portion and the second end portion, wherein one seal of the plurality of seals is positioned between the first separable flexible container and the third separable flexible container to form side edges of the first separable flexible container and a third separable flexible container separated by a second frangible region (right side compartments in Hill Figs. 5-9; Lerner frangible regions); and the first end portion of the third separable flexible container defines a third destructive opening region; the third destructive opening region includes a stress concentration riser positioned to initiate a tear to access the third separable flexible container; the stress concentration riser is surrounded by the seal positioned between the first separable flexible container and the third separable flexible container on the condition that the multi-chamber container assembly is in the filled-and-sealed configuration; the stress concentration riser has a first geometric shape with a closed boundary on the condition that the multi-chamber container assembly is in the filled-and-sealed configuration; and the stress concentration riser has a second geometric shape on a condition that the first separable flexible container is separated from the third separable flexible container (when viewed in combination)
Regarding claim 19, Hill as modified above discloses all limitations of the claim(s) as detailed above except does not expressly disclose the indicia as claimed.
It has been held that when the claimed printed matter is not functionally related to the substrate it will not distinguish the invention from the prior art in terms of patentability. In re Gulack, 217 USPQ 401, (CAFC 1983). The fact that the content of the printed matter placed on the substrate may render the device more convenient by providing an individual with a specific type of information does not alter the functional relationship. Mere support by the substrate for the printed matter is not the kind of functional relationship necessary for patentability.
The Examiner asserts that the Hill as modified above assembly is the same structure claimed by applicant and the sole difference is in the content of printed material. Thus, there is no novel and unobvious functional relationship between the printed matter (e.g., indicia on the assembly) and the substrate (e.g., assembly), which is required for patentability.
Accordingly, there being no functional relationship of the printed material to the substrate, as noted above, there is no reason to give patentable weight to the content of the printed matter, which by itself is non-statutory subject matter. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was made provide the Hill as modified above assembly with indicia for use of the assembly.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hill (US 5024536) in view of Lerner et al. (US 2006/0262997, hereinafter ‘Lerner’) and Yanase (US 4634006) as applied to claim 14 above, and further in view of Ausnit (US 2004/0134166).
Hill as modified above discloses all limitations of the claim(s) as detailed above except does not expressly disclose the destructive opening region/peelable seal as claimed.
However, Ausnit teaches a similar compartmented bag wherein the destructive opening region includes a peelable seal configured such that the first layer can be peeled away from the second layer (para 0049).
At the time of the invention, it would have been obvious to a person having ordinary skill in the art to add a peelable seal as taught by Ausnit to the openings taught by Hill as modified above, in order to give tamper evidencing to a consumer as taught by Ausnit (para 0049).
Response to Arguments
Applicant's arguments filed 10/14/2025 have been fully considered but they are not persuasive.
Applicant argues that the cited references do not teach or suggest that the first end portions of the flexible container define both opening (prior to sealing) and the destructive opening region of the containers. This argument has been considered, however is not persuasive in light of the references cited above teaching both the opening (Hill) and the destructive opening region (combination with Yanase) as claimed.
Applicant’s arguments with respect to claim 21 are moot due to the withdrawal of claims 21+
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 PETER N. HELVEY whose telephone number is (571)270-1423. The examiner can normally be reached Monday-Friday 10am-7pm EST.
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/PETER N HELVEY/Primary Examiner, Art Unit 3734
December 5, 2025