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
Applicant's election with traverse of Group I (claims 1-15 and 19-20) in the reply filed on 12/12/2025 is acknowledged. The traversal is on the ground(s) that the restriction on the ground of lack of serious burden on the examiner. This is not found persuasive because the method claim of Group II further requires to sterilizing the assembly of the tray assembly, the flexible enclosure and the dosing system. Such limitation is not found in the Group I on the invention and requires further search in B65B55/00+. The additional limitation in method claim Group II further increase the search burden upon the examiner due to the divergent classification and distinct claimed limitation.
The requirement is still deemed proper and is therefore made FINAL.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/17/2024 and 05/05/2026 are being considered by the examiner.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “the rigid wall portion” as claimed in claim 10 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-5, 7-9, 11-12, 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Thorne JR. et al (11,312,605).
As to claim 1, Thorne discloses an aseptic system comprising (10): a flexible enclosure (flexible bag 30) ;a tray assembly (50, 70) configured to be disposed within the flexible enclosure (Figure 1), wherein the tray assembly comprises: a first tray (50) configured to support a plurality of container bodies (60, Figure 2A), wherein each of the plurality of container bodies has an opening (96) into a chamber; and a second tray (70) configured to support a plurality of container seals (80), wherein each of the plurality of container seals is configured to seal the opening of a respective one of the plurality of container bodies (Figure 10); and a dosing system (40) comprising a dosing conduit extending through the flexible enclosure (Figures 1 and Figure 1A-B shows the filling dose conduit extending through the bag 30) and the second tray (the second tray further comprises a small hole 130), wherein the flexible enclosure is configured to enable movement of the second tray with the dosing conduit relative to the first tray to dispense a pharmaceutical product into the chamber of each of the plurality of container bodies (the spout 122 interface with the small hole 130 on the second tray 70, able to lifted the plate 70 by displacement of filter/spout assembly 40 within the flexible enclosure, the flexible enclosure is “configured to” enable movement of the second tray when the spout 122 interface with small hole to lift second tray 70 while to dispense a liquid product into the chamber of each of the plurality of container bodies).
As to claim 2, Thorne further discloses the plurality of container bodies (60) disposed in the first tray (50) and the plurality of container seals (80) disposed in the second tray (70).
As to claim 3, Thorne further discloses the plurality of container bodies comprises a plurality of bottles (bottles 60 [0045]).
As to claim 4, Thorne further discloses the first tray (50) comprises a first grid portion (as shown in Figure 2, the first tray 50 with 3 by 4 grid recess 92) disposed in a first housing portion (50) and the second tray (70) comprises a second grid portion (the second tray 70 with also 3 by 4 smaller opening grid ) disposed in a second housing portion, wherein the first grid portion is configured to support the plurality of container bodies and the second grid portion is configured to support the plurality of container seals (Figure 2 and Figure 3).
As to claim 5, Thorne further discloses the first housing portion is a bottom portion having an open top, and the second housing portion is a cover portion having an open bottom.
As to claims 7-9, Thorne further discloses the flexible enclosure comprises a flexible bag with at least 50 percent of the flexible enclosure to at least 90 percent of the flexible enclosure (pliant bag cover).
As to claim 11, Thorne further discloses the flexible enclosure is disposable (a bag is disposable once the tray assembly removed from the bag).
As to claim 12, Thorne further discloses the first tray and the second tray are configured to align the plurality of container bodies with the respective plurality of container seals (as show in Figure 6).
As to claim 19-20, Thorne discloses an aseptic system comprising (10) comprising at least one component of a tray assembly (50, 70) configured to be disposed within a flexible enclosure (flexible bag 30); and a dosing system (40) comprising a dosing conduit extending through the flexible enclosure (Figures 1 and Figure 1A-B shows the filling dose conduit extending through the bag 30) and the at least one component (the second tray comprises a small hole 130, the spout 122 interface with the small hole 130 on the second tray 70), wherein the flexible enclosure (130) is configured to enable movement of the at least one component with the dosing conduit to dispense a pharmaceutical product into a chamber of each of a plurality of container bodies disposed in the tray assembly (the spout 122 interface with the small hole 130 on the second tray 70, able to lifted the plate 70 by displacement of filter/spout assembly 40 within the flexible enclosure, the flexible enclosure is “configured to” enable movement of the second tray when the spout 122 interface with small hole to lift second tray 70 while to dispense a liquid product into the chamber of each of the plurality of container bodies), the tray assembly comprises: a first tray (50) configured to support the plurality of container bodies (60), wherein each of the plurality of container bodies has an opening (96)into the chamber; and a second tray (70) configured to support a plurality of container seals (80), wherein each of the plurality of container seals is configured to seal the opening of a respective one of the plurality of container bodies.
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.
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.
Claims 6 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thorne JR. et al (11312605) in view of Thorne et al (10,800,556).
As to claim 6, Thorne ‘605 does not specifically discloser the flexible enclosure comprises a transparent or translucent material. Nevertheless Thorne ‘556 discloses a kit to delivering liquid into the safety of a sterile environment , the kit comprises a tray (2) for holding plurality of bottles (4) and place inside a clear plastic bag (20).
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 bag of Thorne `605 with clear plastic bag as taught by Thorne `556 in order to view the content within the bag when filling the bottle inside.
As to claims 13, Thorne `605 does not discloses the pharmaceutical product disposed in each of the container bodies via dosing by the dosing system. Nevertheless, Thorne `556 discloses a kit to delivering eye drop into the safety of a sterile environment, comprising an outer bag, tray system inside the outer bag, plurality of bottles (4) disposed in the tray system and filling conduit 50), the eye drop being the pharmaceutical product inside each of the container body via dosing by the dosing. 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 bag of Thorne `605 with clear plastic bag as taught by Thorne `556 in order to view the content within the bag when filling the bottle inside.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Thorne JR. et al (11312605) in view of Patnode et al (5,123,535).
As to claim 10, Thorne does not discloses the flexible closure has a flexible wall portion and a rigid wall portion. Nevertheless, Patnode discloses a flexible sterilized bag (40) comprises flexible two sides container (40) and rigid wall portion (rigid plastic strips 15a and 15b). 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 bag of Thorne with two rigid wall portion act as a handle as taught by Patnode in order to provide support adjacent to the opening to act as carrying handle to support the bag.
Allowable Subject Matter
Claims 14-15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Examiner has cited particular paragraphs and/or columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings of the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested of the applicant, in preparing responses, to fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or prior art(s) disclosed by the Examiner (in the attached PTO-892 form).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHUN HOI CHEUNG whose telephone number is (571)270-5702. The examiner can normally be reached Monday to Friday 9AM-5:30PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Orlando E Aviles can be reached at (571)270-5531. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHUN HOI CHEUNG/Primary Examiner, Art Unit 3736
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