DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the AIA first to file provisions. 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.
Application Status
This office action is in response to the submission filed 11/5/2025.
Claims 1-20 are currently pending; Claims 1-12 have been withdrawn without traverse; Claims 13-20 are being examined.
Information Disclosure Statement
The 2 IDS documents have been considered. See the attached PTO 1449 forms.
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 13-16 and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schroeder US 5,408,804.
Regarding claim 13:
Schroeder teaches a product marrying process, comprising:
providing a tray (2) at a first processing location (12), the tray including
a first compartment (3) proximate to a first end of the tray,
a second compartment (4) proximate to a second end of the tray, and a rim (20) surrounding the first and second compartments;
filling the first compartment of the tray with a first component (see FIG. 6);
placing a flexible cover sheet (6) over the first and second compartments of the tray (shown in FIG. 7);
forming a primary seal (51) between the cover sheet and the tray by heat-sealing the cover sheet to the rim of the tray such that the first compartment is sealed by the primary seal and the second compartment is partially sealed by the primary seal (col. 3, lines 17-22);
sending the tray to a second processing location (25);
filling the second compartment of the tray with a second component (see FIG. 10); and
forming a secondary seal (52) between the cover sheet and the tray by heat-sealing the cover sheet to the rim at the second end of the tray such that the secondary seal complements the primary seal to seal the second compartment (i.e., 51 acted as an initial partial seal of 4, then 52 complemented that seal by fully sealing 4).
Regarding claim 14:
Schroeder teaches the product marrying process according to claim 13, as discussed above, wherein the primary seal is formed on the rim at a first side of the tray and extends from the first end of the tray to the second end of the tray, and wherein the primary seal is further formed on the rim at the second side of the tray and extends from the first end of the tray to the second end of the tray (shown in FIG. 8).
Regarding claim 15:
Schroeder teaches the product marrying process according claim 13, as discussed above, wherein the primary seal is formed on the rim at the first end of the tray and extends from the first side of the tray to the second side of the tray (shown in FIG. 8).
Regarding claim 16:
Schroeder teaches the product marrying process according to claim 13, as discussed above, wherein the secondary seal is formed on the rim at the second end of the tray and extends from a first side of the tray to a second side of the tray (shown in FIG. 12).
Regarding claim 19:
Schroeder teaches the product marrying process according to claim 13, as discussed above, wherein a first edge at the first end of the tray is unsealed after the primary seal is formed such that a first edge of the cover sheet forms a first unsealed flap over the corresponding first edge of the tray (e.g., FIG. 12, see small unsealed gap between 51 and the first end of 2).
Regarding claim 20:
Schroeder teaches the product marrying process according to claim 19, as discussed above, wherein a second edge at the second end of the tray is unsealed after the secondary seal is formed such that a second edge of the cover sheet forms a second unsealed flap over the corresponding second edge of the tray (e.g., FIG. 12, see where numeral 20 is touching).
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Schroeder, as applied above, and further in view of Sokolowski US 5,163,557.
Regarding claim 17:
Schroeder teaches the product marrying process according to claim 13, as discussed above, but does not teach wherein the first component includes a medical device and the second component includes a medication container.
However, analogous multi-compartment medical storage kits are old and well-known in the art. For example, Sokolowski discloses one such kit having a first component including a medical device (30b/c) in a first compartment (20) and a second component including a medication container (30e, or, alternatively, 50) in a second compartment (32e, or, alternatively, 50a).
It would have been obvious to a person having ordinary skill in the art, at the effective filing date of the invention, to modify the process of Schroeder by using the process to store medical devices and medication containers for medication kits, since Schroeder teaches the method “make[s] it possible, at reduced cost, to fill the second chamber of the container without affecting the sterility of the aseptically filled first chamber” (col. 1, lines 24-27) which may be useful in the manufacturing of medical kits.
Response to Arguments
Applicant’s remarks have been carefully considered but are not persuasive for the following reasons.
Applicant’s main argument is that Schroeder does not teach forming a primary seal between the cover sheet and the tray by heat-sealing the cover sheet to the rim of the tray such that the first compartment is sealed by the primary seal and the second compartment is partially sealed by the primary seal. Examiner respectfully disagrees. As clearly shown in FIG. 7 and discussed in col. 3, lines 17-22, a primary seal at 20 is formed fully sealing the first compartment 3, while only partially sealing compartment 4. At this stage, compartment 4 can clearly be considered partially sealed because it is not fully-exposed and not fully-sealed by the primary seal, but rather something in-between. Compartment 4 is later filled and then fully sealed, as subsequently required in claim 13.
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 extension fee 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 DARIUSH SEIF whose telephone number is (408) 918-7542. The examiner can normally be reached on Monday-Friday 9:30 AM-6:00 PM PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ANNA KINSAUL can be reached on 571-270-1926. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DARIUSH SEIF/Primary Examiner, Art Unit 3731