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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 26, 2026 has been entered.
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.
Claims 1-14, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Okihara (U.S. 2015/0182686) in view of Kuhn et al. (“Scratch tests on micro-structured polymer surfaces…”, Journal of Micromechanics and Microengineering, INSTITUTE OF PHYSICS PUBLISHING, BRISTOL, GB, vol. 21, no. 6, 18 May 2011 (2011-05-18), page 65031, XP020205575, ISSN: 0960-1317, DOI: 10.1088/0960-1317/21/6/065031) and Cristofolli et al. (WO 2021126679A1).
Regarding claim 1, Okihara teaches a holding device 1 for holding a plurality of primary packaging containers 21 for pharmaceutical, medical, or cosmetic compositions, the holding device comprising a plate-shaped carrier element 11 which includes a plurality of through-holes (holes defined by 13), a plurality of receptacles 13, each of which is configured for accommodating a respective one of the plurality of primary packaging containers 21, each of the plurality of receptacles 21 including a longitudinal direction, a first end (upper end of 21), a second end (lower end of 21), and a receptacle wall (cylindrical wall of 13) which partially encloses a receptacle interior and forms a wall body, the wall body extending in the longitudinal direction (figure 1) through a respective one of the plurality of through-holes (figure 1), and including a first opening at the first end (upper end), a second opening at the second end (lower end) which, in the longitudinal direction, is opposite to the first end, at least one first edge (edge of opening of 13 at upper end), and at least one second edge (edge of opening at lower end), the first opening of the wall body being laterally directly surrounded by the at least one first edge (figure 1), the second opening of the wall body being laterally directly surrounded by the at least one second edge (figure 1).
Okihara discloses the claimed invention except for the total height Rt of a roughness profile of at least one of the at least one first edge and the at least one second edge which is not more than 0.50 mm. Kuhn et al. teaches that it is known that polypropylene has total height Rt of a roughness profile of at least one of the at least one first edge and the at least one second edge which is not more than 0.50 mm (see table 5). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide the device of Okihara with the total height Rt of a roughness profile of at least one of the at least one first edge and the at least one second edge which is not more than 0.50 mm, as taught by Kuhn et al., in order to have reduced surface irregularities for proper seating of the receptacle.
Further regarding claim 1, the modified holding device of Okihara also does not disclose the plurality of surfaces adjacent the first corner and the second corner. Cristofolli et al. teaches that it is known to provide a holding device with a plurality of surfaces adjacent the first corner and the second corner (see figure 3D; plurality of surfaces adjacent upper corner and lower corner). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide the modified holding device of Okihara with the plurality of surfaces adjacent the first corner and the second corner, as taught by Cristofolli et al., in order to direct and center the receptacle into the opening.
Regarding claim 2, for each of the plurality of receptacles, the wall body has an interior surface which faces the receptacle interior (radially inwardly), and an exterior surface which faces opposite to the interior surface (facing radially outwardly).
Regarding claim 3, for each of the plurality of receptacles, the wall body includes at least one intermediate surface which (a) is neither part of the interior surface nor of the exterior surface, and (b) faces in the longitudinal direction or in a counter-direction of the longitudinal direction, wherein at least 50 % of respective ones of the plurality of receptacles have a maximum total height Rt of a roughness profile of the at least one intermediate surface of not more than 0.50 mm (as modified by Kuhn et al. above).
Regarding claim 4, the maximum total height Ry of the roughness profile of the at least one intermediate surface is not more than 0.30 mm (as modified by Kuhn et al. above).
Regarding claim 5, the maximum total height Rt of the roughness profile of the at least one intermediate surface is not more than 0.10 mm (as modified by Kuhn et al. above).
Regarding claim 6, the total height Rt of the roughness profile of at least one of the at least one first edge and the at least one second edge is not more than 0.40 mm (as modified by Kuhn et al. above).
Regarding claim 7, the total height Rt of the roughness profile of at least one of the at least one first edge and the at least one second edge is not more than 0.30 mm (as modified by Kuhn et al. above).
Regarding claim 8, the total height Rt of the roughness profile of at least one of the at least one first edge and the at least one second edge is not more than 0.20 mm (as modified by Kuhn et al. above).
Regarding claim 9, the total height Rt of the roughness profile of at least one of the at least one first edge and the at least one second edge is not more than 0.10 mm (as modified by Kuhn et al. above).
Regarding claim 10, at least 60% of respective ones of the plurality of receptacles have the total height Rt of the roughness profile of the at least one first edge (all the receptacles are formed of polypropylene modified by Kuhn above).
Regarding claim 11, at least 70% of respective ones of the plurality of receptacles have the total height Rt of the roughness profile of the at least one first edge (all the receptacles are formed of polypropylene modified by Kuhn above).
Regarding claim 12, at least 80% of respective ones of the plurality of receptacles have the total height Rt of the roughness profile of the at least one first edge (all the receptacles are formed of polypropylene modified by Kuhn above).
Regarding claim 13, at least 90% of respective ones of the plurality of receptacles have the total height Rt of the roughness profile of the at least one first edge (all the receptacles are formed of polypropylene modified by Kuhn above).
Regarding claim 14, for each of the plurality of receptacles, the wall body has an interior surface which faces the receptacle interior (radially inwardly) and an exterior surface which faces opposite to the interior surface (facing radially outwardly), and at least 50% of respective ones of the plurality of receptacles have a maximum total height Rt of a roughness profile of the interior surface which is not more than 0.50 mm (all the receptacles are formed of polypropylene modified by Kuhn above).
Regarding claim 19, the plurality of primary packaging containers are selected from the group consisting of vials; syringes; cartridges; ampoules; or a combination of at least two thereof (element 21 of Okihara).
Regarding claim 20, Okihara teaches a transport unit 1, comprising an arrangement including a holding device 10, 11 for holding a plurality of primary packaging containers 21 for pharmaceutical, medical, or cosmetic compositions, the holding device comprising a plate-shaped carrier element 11 which includes a plurality of through-holes (defined by 13), a plurality of receptacles 13, each of which is configured for accommodating a respective one of the plurality of primary packaging containers 21, each of the plurality of receptacles including a longitudinal direction, a first end (upper end), a second end (lower end), and a receptacle wall which partially encloses a receptacle interior and forms a wall body at 13 (figure 1), the wall body extending in the longitudinal direction through a respective one of the plurality of through-holes (figure 1), and including a first opening at the first end (upper opening), a second opening (lower opening) at the second end which, in the longitudinal direction, is opposite to the first end, at least one first edge (edge of upper opening), and at least one second edge (edge of second opening), the first opening of the wall body being laterally directly surrounded by the at least one first edge, the second opening of the wall body being laterally directly surrounded by the at least one second edge (figure 1), and a secondary packaging container 10, the holding device and the plurality of primary packaging containers being arranged completely in the secondary packaging container (figure 1).
Further regarding claim 20, Okihara discloses the claimed invention except for the total height Rt of a roughness profile of at least one of the at least one first edge and the at least one second edge which is not more than 0.50 mm. Kuhn et al. teaches that it is known that polypropylene has total height Rt of a roughness profile of at least one of the at least one first edge and the at least one second edge which is not more than 0.50 mm (see table 5). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide the device of Okihara with the total height Rt of a roughness profile of at least one of the at least one first edge and the at least one second edge which is not more than 0.50 mm, as taught by Kuhn et al., in order to have reduced surface irregularities for proper seating of the receptacle.
Additionally regarding claim 1, the modified holding device of Okihara also does not disclose the plurality of surfaces adjacent the first corner and the second corner. Cristofolli et al. teaches that it is known to provide a holding device with a plurality of surfaces adjacent the first corner and the second corner (see figure 3D; plurality of surfaces adjacent upper corner and lower corner). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide the modified holding device of Okihara with the plurality of surfaces adjacent the first corner and the second corner, as taught by Cristofolli et al., in order to direct and center the receptacle into the opening.
Claims 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Okihara (U.S. 2015/0182686) in view of Kuhn et al. (“Scratch tests on micro-structured polymer surfaces…”, Journal of Micromechanics and Microengineering, INSTITUTE OF PHYSICS PUBLISHING, BRISTOL, GB, vol. 21, no. 6, 18 May 2011 (2011-05-18), page 65031, XP020205575, ISSN: 0960-1317, DOI: 10.1088/0960-1317/21/6/065031) and Cristofolli et al. (WO 2021126679A1), as applied to claim 1 above, and further in view of Anil et al. (WO 2016166765A1).
Regarding claim 15, the modified device of Okihara discloses the claimed invention except for the retaining part. Anil et al. teaches that it is known to provide a wall body with a retaining part (see element 15). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide the modified device of Okihara with the retaining part, as taught by Anil et al., in order to grip the receptacle.
Regarding claim 16, the retaining part includes a lateral surface (figure 6 of Anil et al.), wherein, for each of the plurality of receptacles, the first opening or the second opening is laterally limited by the lateral surface of the retaining part (15 of Anil et al.), wherein at least 50% of respective ones of the plurality of receptacles have a maximum total height Rt of a roughness profile of the lateral surface of the retaining part of not more than 0.50 mm (as modified by Kuhn et al. above).
Regarding claim 17, the maximum total height Rt of the roughness profile of the lateral surface of the retaining part is not more than 0.30 mm (as modified by Kuhn et al. above).
Regarding claim 18, the maximum total height Rt of the roughness profile of the lateral surface of the retaining part is not more than 0.10 mm (as modified by Kuhn et al. above).
Response to Arguments
Applicant's arguments filed January 26, 2026 have been fully considered but they are not persuasive. Applicant argues that the secondary reference of Khun et al. does not teach “at least 50% of respective ones of the plurality of receptacles having a total height Rt of a roughness profile of at least one of the at least one first and the at least one second edge which is not more than 0.50mm.” It is the examiner’s position that table 5 of Kuhn et al. shows the difference between the highest peak and deepest valley being less than 0.50 mm. Table 5 of Kuhn gives values for the structure heights and maximum scratch depth, these values show a roughness profile of the material which is less than 0.50mm, to the degree set forth in the claims. All the receptacles are similarly modified by the secondary reference, therefor at least 50% of the receptacles have the claimed roughness profile.
Regarding the newly added limitation that there are a plurality of surfaces adjacent the first and second edges, the secondary reference of Cristofolli et al. (WO 2021126679A1) has been added to the rejection for the teaching of providing a plurality of surfaces adjacent the first and second edges, as shown in figure 3D of Cristofolli et al. (WO 2021126679A1).
Conclusion
THIS ACTION IS MADE NON-FINAL.
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/NIKI M ELOSHWAY/Examiner, Art Unit 3736