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Claims 1-3, 5, 6, 9, 10 and 14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 03/06/2026.
Applicant's election with traverse of Species II in the reply filed on 03/06/2026 is acknowledged. The traversal is on the ground(s) that the different species does not involve a serious search burden on the Examiner, wherein a search for the two different species overlaps one with the other. This is not found persuasive because Species II requires a structure of a tray not required by Species I, and the insert required by Species II is different than the insert required in Species I. The prior art that meets the limitations of Species I not necessarily could be used to reject the limitations required by Species II, therefore the search between Species I and Species II, and the invention between Species I and II is different. The examiner is not entitled to examined multiple inventions within a single application.
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 32 and 63-65 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Regarding claim 32, language reciting “wherein at least one of the plurality of containers includes a drug vial” is indefinite because it is unclear if the plurality of containers are positively claimed as part of the invention or not. The claim further limits the plurality of containers “drug vial”, but the plurality of containers are not positively claimed in claim 15. Claim 15, in the preamble, only requires the system with the capability of packaging a plurality of containers. Same issue happens in claims 63-64 because not only further limits what is contained in the drug vial and/or the type of drug vial is the plurality of containers, but also claims 63-64 inherits the same issue of claim 32 because are of its dependency. Regarding claim 65, language reciting “wherein: the plurality of containers includes at least a first drug vial and a second drug vial, the first drug vial is one of: an ISO 2R vial, an ISO 6R vial, an ISO 10R vial, an ISO 20R vial, or an ISO 50R vial, and the second drug vial is a different one of: an ISO 2R vial, an ISO 6R vial, an ISO 10R vial, an ISO 20R vial, or an ISO 50R vial.” Is indefinite because as in claim 32, it is unclear if the plurality of containers are positively claimed or not because in claim 15, the plurality of containers are not part of the invention but in claim 65, the applicant is further defining the type of container in the system. Appropriate correction is required.
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.
Claims 15, 16, 20, 24, 26, 32 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over KR 2024/0001282 in view of Narcisse (US 2022/0324608) and Creager (US 2022/0024666).
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Claims 15 and 36
KR ‘282 discloses a system for packaging a plurality of containers, comprising a box having an assembled configuration (see figure 5a), the carton comprising a bottom box (100) having a first bottom wall (120), a first sidewall, a second sidewall, a first back wall, and a first front wall when the carton is in the assembled configuration (see figure above); a lid (110) coupled to the bottom box and movable between an open position and a closed position (see abstract); a tray (defined by panels 142 and 143) coupled to the bottom box and movable between a first position (defined by panels extending out of the bottom box as shown in figure 3) and a second position (defined by panels extending in the interior of the bottom box as shown in figure 5a); a first flap (152) extending from the first sidewall of the bottom box; and a second flap (162) extending from the second sidewall of the bottom box, the second sidewall being opposite the first sidewall and facing the first sidewall (see figure 1 and page 3); and an insert (200) configured to be disposed within the bottom box of the carton, the insert having a storage configuration where the insert is substantially flat (see figure 6) and an assembled configuration (see figure 7), and where the insert defines a plurality of cavities (211 and 231), each cavity dimensioned to house a respective one of a plurality of containers (see abstract), wherein, in the assembled configuration, the insert comprises a top wall (210), a third sidewall (220), a fourth sidewall (220), a second back wall (250), a second front wall (220), and a first middle wall (230) positioned between the top wall and bottom wall of the bottom box when inserted into the bottom box, and wherein the top wall and the first middle wall define the plurality of cavities (211 and 231) (see figures 6 and 7). KR ‘282 does not explicitly discloses the bottom box is a carton having a storage configuration being substantially flat. KR’ 282 does not explicitly discloses the material for the bottom box and the insert. KR ‘282 does not disclose the insert comprising a second bottom wall, as required. However, the limitation of the bottom box formed from a substantially flat carton, Narcisse discloses a packaging container system (10) comprising a bottom box (12) formed from a flat carton/paperboard which when in assembled configuration is used to carry insert trays (12 and 14) for holding and maintaining in place containers (100), wherein the bottom box and the inserts are made from paperboard material (see figures 2, 3 and [0031]-[0033]). 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 bottom box of KR ’282 being formed from a flat carton, and wherein the bottom box and the insert are formed from paperboard material as taught by Narcisse because it is known and nominal in the art boxes and inserts formed from flat cartons of paperboard material. Regarding the limitation of the second bottom wall of the insert, Creager discloses a tray insert (230) for holding boxes (110) comprising a top wall (232), a middle wall (234), and a bottom wall (236), the top and middle walls include apertures (231 and 233) for receiving the boxes, and bottom wall contacts a bottom of the boxes and rests on the bottom of outer box (344) (see [0057]). 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 insert of KR ‘282 having a bottom wall as taught by Creager to provide better stability to the containers stored and placed in the insert.
Claim 16
KR ‘282 further discloses the tray is configured to define a second bottom box disposed within the bottom box when the tray is in the second position. When the tray is in second position, the tray is capable of holding additional articles between panel (143) of the tray and first bottom wall of the bottom box.
Claim 20
KR ‘282 further discloses when the insert is disposed within the bottom box of the carton, the third sidewall is configured to abut the first sidewall, the fourth sidewall is configured to abut the second sidewall, the second back wall is configured to abut the first back wall, and the second front wall is configured to abut the first front wall. After KR ‘282 is modified by Creager, the second bottom wall will be configured to abut the first bottom wall.
Claim 24
KR ‘282 further discloses a number of cavities defined by the top wall is equal to a number of cavities defined by the first middle wall (see figures 6 and 7).
Claim 26
KR ‘282 further discloses each of the plurality of cavities have equal dimensions (see figure 6).
Claim 32
KR ‘282 further discloses the plurality of containers comprises ampules/drug vial, wherein the drug vial is filled or pre filled with a drug (see pages 2 and 3).
Claim 63 is rejected under 35 U.S.C. 103 as being unpatentable over KR 2024/0001282 in view of Narcisse (US 2022/0324608) and Creager (US 2022/0024666) as applied to claim 32 above, and further in view of Qi WO 2023/278585).
KR ‘282 further discloses does not specifically disclose the drug vial is filled with a drug comprising tarlatamab. However, Qi discloses a pharmaceutical composition, i.e. tarlatamab, disposed within an ampoule (see [0049], [0073] and [0078]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify KR ‘282 having tarlatamab as the drug/pharmaceutical formulation held within the container/ampoules, as a type of pharmaceutical held within ampoule.
Claims 64 and 65 are rejected under 35 U.S.C. 103 as being unpatentable over KR 2024/0001282 in view of Narcisse (US 2022/0324608) and Creager (US 2022/0024666) as applied to claim 32 or 15 above, and further in view of Bucholtz (WO 2022/109619).
Claims 64 and 65
KR ‘282 does not disclose any of the vials is one of ISO 2R vial, ISO 6R vial, ISO 10R vial, ISO 20R vial, or ISO 50R vial. However, Bucholtz discloses a vial (110) meeting ISO 2R, ISO 5R, ISO 10R, etc standards are known in the art (see [0017], [0063] and [0064]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify KR ‘282 having the vials meeting any of the required standard, i.e. ISO 2R, ISO 5R, or ISO 10R, since vials meeting any of those required standards are well-known and common in the art, depending on the desired vial size. After KR ‘282 is modified by Bucholtz at least two drug vials will meet the required standard.
Allowable Subject Matter
Claims 17, 18, 23, 28 and 29 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 RAFAEL A. ORTIZ whose telephone number is (571)270-5240. The examiner can normally be reached Monday - Friday 9am - 6pm.
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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RAFAEL A. ORTIZ
Primary Examiner
Art Unit 3736
/RAFAEL A ORTIZ/Primary Examiner, Art Unit 3736
Prosecution Insights