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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/24/2025 has been entered.
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.
Claim(s) 1-5, 9-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Radmer (WO 2007101772) in view of Ogawa et al. (US Patent 8863948 hereinafter “Ogawa”).
Regarding Claim 1, Radmer teaches (Fig 3) a system for preparing and dispensing a mixture of at least a first (13) and a second (14) substance comprising:
i) a container (4) for the first substance (13);
ii) a closure cap (6) of the container (4);
iii) a capsule (15, 3, 12) applied to a mouth of the container (4; Pg. 14 lines 10-12 teaches 15 is connected to neck of vial 4, the neck is interpreted to be the 'mouth' of the container 4) and comprising:
a containment chamber (2) for the second substance (14);
a perforation means (5,7) for perforating the chamber (2) and the cap (6); said system (1) taking on a rest configuration (Fig 3) wherein the inside of the container (4) and the inside of the containment chamber (2) are fluid-dynamically separated and an operating configuration wherein said perforation means (5,7) extends into the chamber (2) and passes through the cap (6; see Pg. 14 lines 17-19);
iv) a mixture withdrawal mouth (27) which is part of said capsule (15, 3, 12) and of said chamber (2) and defines a tubular element (See Fig 3, 27 is tubular); said withdrawal mouth (27) being intended to dispense the mixture of the first and second substances outside the system (Pg. 15 lines 8-15; Pg. 17 lines 3-8); the chamber (2) comprising:
- a portion (17) intended to be perforated by the perforation means (5,7); the portion (17) being irreversibly perforable;
- a bottom (surface 18) opposite the perforable portion (17);
- an intermediate lateral side (wall 19 or side walls of reservoir 2);
the withdrawal mouth (27) being afforded in a zone opposite the perforable portion (17);
said cap (6) possibly being or not being part of the capsule (15, 3, 12);
a movement of said chamber (2) bringing about a passage from the rest configuration to the operating configuration (Pg. 16 lines 6-14); said perforation means (5,7) comprising a conduit (hollow parts of spikes 5,7) which in said operating configuration places the inside of the container (4) in communication with the inside of the chamber (2); the perforation means (5,7), in a predefined configuration, extending into the chamber (2), passing through the cap (6) and extending into the mixture withdrawal mouth (27; see Pg. 15 lines 8-15 teaches 7 pierces into 27);
Radmer does not specify wherein said withdrawal mouth, in the rest configuration, is in fluid communication with the chamber.
Ogawa teaches a system for preparing and dispensing a mixture of a first and second substance (Figs 1-2) wherein a withdrawal mouth (321) in the rest configuration (Fig 1) is in fluid communication with a chamber (30, 323; See Col 4 lines 38-44). Ogawa teaches a valve element (33) that functions as a first seal fir closing the withdrawal mouth (321; see Col 4 lines 52-55).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the seal (28; Fig 3) of Radmer with the seal valve element (33) of Ogawa. This would result in the withdrawal mouth of Radmer, in the rest configuration, is in fluid communication with the chamber (as similarly taught by Ogawa). One of ordinary skill in the art would have been motivated to do so as this substitution would provide similar results of ensuring the withdrawal mouth is sealed until a syringe is attached for fluid communication with the chamber (See Ogawa Col 5 lines 1-9).
Regarding Claim 2, the combination of Radmer and Ogawa teaches all elements of claim 1 as described above. Radmer further teaches the system characterised in that the passage from the rest configuration to the operating configuration is enabled by a movement of the chamber (2) along a mixing direction (Fig 3, 31); said perforation means (5,7) for perforating the chamber (2) and the cap (6) in the rest configuration (Fig 3) is interposed between the chamber (2) and the cap (6) along the mixing direction (31).
Regarding Claim 3, the combination of Radmer and Ogawa teaches all elements of claim 2 as described above. Radmer further teaches the system characterised in that the perforation means (5,7) is movable along said mixing direction (31; Pg. 15 lines 17-21).
Regarding Claim 4, the combination of Radmer and Ogawa teaches all elements of claim 1 as described above. Radmer further teaches the system according to claim 1, characterised in that the perforation means (5,7) comprises: a first perforator (7) which, in the rest configuration (Fig 3), is oriented towards the chamber (2); a secondo perforator (5) which, in the rest configuration (Fig 3), is oriented towards the cap (6).
Regarding Claim 5, the combination of Radmer and Ogawa teaches all elements of claim 4 as described above. Radmer further teaches the system characterised in that the perforation means (5,7) comprises a single monolithic piece that comprises both the first and the second perforator (5, 7; see Fig 3; 5,7 appears to be a single piece with both spikes 5,7; the examiner also notes that "a single monolithic piece that comprises both the first and the second perforator" is considered a product by process limitation. A product-by-process limitation adds no patentable distinction to the claim, and is unpatentable if the claimed product is the same as a product of the prior art. MPEP 2173.05(p)).
Regarding Claim 9, the combination of Radmer and Ogawa teaches all elements of claim 1 as described above. Radmer further teaches the system characterised in that the perforation means (5,7) comprises a single channel suitable for having a fluid pass through it and coinciding with the conduit (Pg. 14 lines 17-19).
Regarding Claim 10, the combination of Radmer and Ogawa teaches all elements of claim 1 described above. Radmer further teaches a method for dispensing the mixture of the first (14) and second (13) substances using a system (1) according to claim 1, characterised in that it comprises the steps of: move the chamber (2) closer to the container (4; Pg. 15 lines 17-29); said perforation means (5,7) perforating said cap (6) and said containment chamber (2) and placing the inside of the chamber (2) in fluid communication with the container (4; see Pg. 15 lines 17-29); mixing the first substance (14) placed in the containment chamber (2) with the second substance (13) placed in the container (4; Pg. 15 lines 17-29);withdrawing the mixture of the first and second substances by means of a syringe applied to said withdrawal mouth (27; Pg. 15 lines 30-34).
Regarding Claim 11, the combination of Radmer and Ogawa teaches all elements of claim 1 as described above. Radmer further teaches the system characterised in that the mixture withdrawal mouth (27) is being approachable to said portion (17) intended to be perforated by the perforation means (5,7).
Regarding Claim 12, the combination of Radmer and Ogawa teaches all elements of claim 1 as described above. Radmer further teaches the system characterised in that the capsule (15, 3, 12) comprising an openable lid (29) for closing the withdrawal mouth (27); the lid (29) being located in a zone of the capsule (15, 3, 12) opposite the container (2).
Regarding Claim 13, the combination of Radmer and Ogawa teaches all elements of claim 1 as described above. Radmer further teaches the system characterised in that the withdrawal mouth (27) is afforded along a wall (18) that delimits the chamber (2).
Regarding Claim 14, the combination of Radmer and Ogawa teaches all elements of claim 1 as described above. Radmer further teaches the system characterised in that the mouth (27) is on the bottom (18) of the chamber (2).
Regarding Claim 15, the combination of Radmer and Ogawa teaches all elements of claim 1 as described above. Radmer further teaches the system characterised in that the mouth (27) extends inside the chamber (2).
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Radmer (WO 2007101772) in view of Ogawa et al. (US Patent 8863948) as applied to claim 1 above, and further in view of Arigano et al. (US 8545476 hereinafter “Arigano”).
Regarding Claim 6, the combination of Radmer and Ogawa teaches all elements of claim 1 as described above. The combination does not specify the system characterised in that said capsule comprises: a wall that surrounds the chamber and defines a space between the wall and the chamber; a telescopic side; said telescopic side, in the operating configuration, extending into said space to a greater extent than in the rest configuration; in the rest configuration said telescopic side possibly extending or not extending into said space.
Arigano teaches a system characterised in that said capsule (20,30,100) comprises: - a wall (30) that surrounds the chamber (70; see Fig 2, how 30 is cylindrical, due to this shape 30 will surround the chamber 70) and defines a space (annotated Figs 3 and 5) between the wall (30) and the chamber (70); - a telescopic side (100); said telescopic side (100), in the operating configuration (Fig 5), extending into said space (annotated Figs 3 and 5) to a greater extent than in the rest configuration (Fig 3); in the rest configuration said telescopic side (100) possibly extending or not extending into said space (annotated Figs 3 and 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the capsule of Radmer such that it comprises a wall that surrounds the chamber and defines a space between the wall and the chamber; a telescopic side; said telescopic side, in the operating configuration, extending into said space to a greater extent than in the rest configuration; in the rest configuration said telescopic side possibly extending or not extending into said space as taught by Arigano. One of ordinary skill in the art would have been motivated to do so in order to prevent movement or shifting of components prior to activation (Arigano Col 10 lines 13-21).
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Annotated Figs 3 and 5 (Arigano)
Regarding Claim 7, the combination of Radmer, Ogawa and Arigano teaches all elements of claim 6 as described above. Arigano further teaches the system characterised in that the perforation means (40) is slidable along said telescopic side (100) during the movement from the rest configuration to the operating configuration (see Figs 3-5, where the telescopic slide 100 moves relative to the perforation means 40).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Radmer (WO 2007101772) in view of Ogawa et al. (US Patent 886394) as applied to claim 1 above, and further in view of Haber et al. (US Patent 5158546 hereinafter “Haber”).
Regarding Claim 8, the combination of Radmer and Ogawa teaches all elements of claim 1 as described above. The combination does not specify the system characterised in that it comprises a single removable anti-tamper seal; said seal, if present, defining a barrier that prevents the passage from the rest configuration to the operating configuration; said seal, if removed, enabling a passage from the rest configuration to the operating configuration.
Haber teaches a system (2) including a single removable anti-tamper seal (38) that if removed allows for the system attach to the mixing container (col 3 line 62 – Col 4 line 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Radmer such that it includes a single removable anti-tamper seal as taught by Haber. One of ordinary skill in the art would have been motivated to do so in order to allow the user a visual indication if the system has been tampered with.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection takes into consideration the amendments filed 10/24/2025.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEERAJA GOLLAMUDI whose telephone number is (571)272-6449. The examiner can normally be reached Mon-Fri 8-5.
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/NEERAJA GOLLAMUDI/Examiner, Art Unit 3783 /QUYNH-NHU H. VU/Primary Examiner, Art Unit 3783