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 .
Response to Arguments
The previous claims have been cancelled. Therefore, the previous claim objections and claim rejections under 35 U.S.C. 112(b) are withdrawn. However, new rejections under 35 U.S.C. 112(b) follow below.
The previous objections to the drawings are withdrawn.
Applicant’s arguments with respect to new claims 85-100 and 102 (Remarks, page 20) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Interpretation
In view of Applicant’s remarks regarding the lid formed as one piece with the stirrer element (see Remarks, page 19), the “lid formed as one piece with the stirrer element” is interpreted to mean a portion of the lid is formed as one piece with the stirrer element as shown below:
PNG
media_image1.png
823
736
media_image1.png
Greyscale
Claim 95 recites “a container for holding a solid component” and “the container is configured for insertion and use as the first container within the device of claim 85” and the claim is understood to further limit claim 85 by reciting further limitations of the first container.
The claim would be clearer if rewritten as “The device of claim 85, wherein the first container is configured for insertion within the device and deliverable pre-filled with the solid-component; the first container is configured to be operatively connected or connectable to the dosing device for metering the solid component from the first container.” or similar.
Claim 97 recites “a container for holding a fluid” and “the container is configured for insertion and use as a second container within the device of claim 85” and the claim is understood to further limit claim 85 by reciting a second container and further limitations of the second container.
The claim would be clearer if rewritten as “The device of claim 85, wherein a second container is configured for insertion within the device and deliverable pre-filled with a fluid; the second container comprises a housing that defines an interior space for holding the fluid; the second container is configured to be operatively connected or connectable to a fluid dosing device.” or similar.
It is noted that “a claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers”. See MPEP 608.01(n)(III).
It is noted that preambles of claims dependent on claims 95 or 97 should be rewritten as “the device of claim……” if amended as above. If Applicant amends claims, it is recommended to refer to the solid and fluid containers as “first container” and “second container” throughout the claims rather than “container” to avoid issues under 35 U.S.C. 112(b).
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 95-96 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.
Claim 95 depends on claim 85 and recites “a dosing device” in line 5 and it is unclear if this is the same dosing device previously recited in claim 85 or a different dosing device. Claim 85 recites “at least one dosing device” and it is unclear how many dosing devices are required by claim 95. For the purpose of examination, “a dosing device” of claim 95 is interpreted to mean the same “at least one dosing device” recited in claim 85. This could be changed to “the dosing device”.
Claim 96 is rejected by virtue of its dependency on claim 95.
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 85, 87, 91 and 93 are rejected under 35 U.S.C. 103 as being unpatentable over Dubief et al. (US 20190274468) in view of Moretto (US 20190117009) and Wang et al. (US 20200297000).
Regarding claim 85, Debief et al. discloses a device for metering and/or preparing (dosing ingredients for a beverage, pars. [0001] and [0008]) a mixture of substances (para. [0001]) as shown below:
PNG
media_image2.png
375
672
media_image2.png
Greyscale
Dubief et al. discloses the device comprises: at least one first container (reservoir 107, para. [0094]) that is configured to hold at least one solid component (dry beverage powder, para. [0096]); at least one first dosing device (dosing device 108) for dosing the at least one solid component (dry beverage powder, para. [0096]), the at least one first dosing device being: connected to or connectable to the first container (Fig. 1), and configured to dose the solid component from the first container (Fig. 1, para. [0095]); at least one preparation unit comprising a mixing chamber (mixing chamber 1), the mixing chamber being configured to receive the dosed solid component (para. [0095]) and a fluid (water via tank 101/second container shown above) to form a substance mixture (para. [0001]).
Dubief et al. does not disclose a sterile filter or sterile membrane.
However, Moretto discloses a device for preparing a mixture of substances (beverage preparation device, Abstract) having a mixing chamber (“beverage preparation unit 5” reads on “mixing chamber” as this is where ingredients are contacted, para. [0033], Fig. 1, and therefore mixed) and Moretto discloses a sterile filter (filter 4 is a bacteria filter, para. [0042]-[0044] and the beverage may be “bacteria free” without boiling, para. [0046]) arranged downstream of a mixing chamber (unit 5, Fig. 1) as shown below:
PNG
media_image3.png
588
716
media_image3.png
Greyscale
Therefore, 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 teachings of Dubief et al. wherein the device includes a sterile filter or sterile membrane arranged downstream of the mixing chamber, fluidically connected to a collection container (Dubief et al., cup 113, Moretto, container C), and configured to allow sterile transfer of the substance mixture from the preparation unit to the collection container (Moretto, “bacteria-free”, para. [0046]).
The person of ordinary skill in the art would have been motivated to include a sterile filter in order to remove bacteria or achieve a bacteria-free beverage (Moretto, para. [0046]).
Assuming, arguendo, that the filter taught by Moretto is not a sterile filter; Wang et al. discloses a system for preparing a mixture (ready-to-drink beverages prepared with a mixing component, Abstract) and Wang et al. further teaches wherein a sterile filter is used in the system (para. [0027]).
Therefore, 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 teachings of Dubief et al. in view of Moretto wherein a sterile filter is used.
The person of ordinary skill in the art would have been motivated to use a sterile filter in order to remove microorganisms from a beverage (Moretto, para. [0046], Wang et al., para. [0027]).
Regarding claim 87, Dubief et al. discloses wherein the device further comprises: at least one second container (tank 101) that is configured to hold the fluid; and at least one second dosing device (pump 102) that is connected to or connectable to the second container (para. [0100]), wherein: the second dosing device is configured to selectively deliver a dose of the fluid to the mixing chamber so that a dose of the solid component can be mixed with a dose of the fluid (para. [0108]).
Regarding claim 91, Dubief et al. discloses wherein the device comprises a fluid line (supply tube 106, Fig. 1, shown above for claim 1) for selectively providing the fluid to the mixing chamber (chamber 1).
Regarding claim 93, the combined teaching of the above-cited references for claim 85 disclose wherein the sterile filter is arranged downstream of the mixing chamber (Moretto, filter 4, Fig. 1).
Claims 86 and 88 are rejected under 35 U.S.C. 103 as being unpatentable over Dubief et al. (US 20190274468) in view of Moretto (US 20190117009) and Wang et al. (US 20200297000) as applied to claim 85 or claim 87 above and in further view of White (US 20130306672).
Regarding claims 86 and 88, Dubief et al. does not expressly disclose wherein the at least one first container and the at least one first dosing device are integrated into or combined as a single, selectively replaceable unit.
However, White discloses a device for preparing a mixture and White further teaches a first container (hopper 20) and a first dosing device (screw 26) and White teaches wherein the at least one first container and the at least one first dosing device are integrated into or combined as a single unit (combined as a single unit, Fig. 4) which is selectively replaceable in that they may be removed from the device for replacement (para. [0039]).
Therefore, 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 teachings of Dubief et al. wherein the at least one first container and the at least one first dosing device are integrated into or combined (White, at least combined, Fig. 4) as a single, selectively replaceable unit.
The person of ordinary skill in the art would have been motivated to make the container and dosing device replaceable in order to facilitate maintenance/replacing parts or cleaning (White, para. [0039]).
Claim 89 is rejected under 35 U.S.C. 103 as being unpatentable over Dubief et al. (US 20190274468) in view of Moretto (US 20190117009) and Wang et al. (US 20200297000) as applied to claim 87 above and in further view of Hengesbach et al. (US 20150289704) and Weibel et al. (US 20160213851).
Regarding claim 89, Dubief et al. does not explicitly disclose the second container and the at least one second dosing device are integrated into or combined as a single, selectively replaceable unit.
However, Hengesbach et al. discloses a device which is analogous art at least because it is reasonably pertinent to the problem of dosing liquids from containers (container 14) under sanitary conditions (Abstract) and Hengesbach et al. discloses a container (container 14) and a dosing device (piston pump 12) for a fluid are integrated into or combined as a single (at least combined as shown in Fig. 1), selectively replaceable unit (the container is replaceable and disposable, para. [0029], and components of the dosing device/pump may be disposable, pars. [0048], including the nozzle 32 and piston 22 which connect to the container 14, Fig. 2).
Likewise, Weibel et al. discloses a device which is analogous art at least because it is reasonably pertinent to the problem of dosing fluids from containers (Abstract) under sanitary or sterile conditions (aseptic, para. [0001]) and Weibel et al. discloses a container (container 2) and dosing device (conveying device 5) wherein the container and dosing device are integrated into or combined as a single (at least combined, Fig. 1), selectively replaceable unit (disposable unit is desirable, para. [0008]).
Therefore, 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 teachings of Dubief et al. wherein the at least one second container and the at least one second dosing device are integrated into or combined as a single, selectively replaceable unit.
The person of ordinary skill in the art would have been motivated to combine the container and dosing unit as a selectively replaceable unit in order to maintain a sterile system (Weibel et al., para. [0008]) or to eliminate the need for cleaning surfaces in contact with fluid.
Claim 90 is rejected under 35 U.S.C. 103 as being unpatentable over Dubief et al. (US 20190274468) in view of Moretto (US 20190117009), Wang et al. (US 20200297000), Hengesbach et al. (US 20150289704) and Weibel et al. (US 20160213851) as applied to claim 89 above and in further view of White (US 20130306672).
Regarding claim 90, Dubief et al. does not expressly disclose wherein the at least one first container and the at least one first dosing device are integrated into or combined as a single, selectively replaceable unit.
However, White discloses a device for preparing a mixture and White further teaches a first container (hopper 20) and a first dosing device (screw 26) and White teaches wherein the at least one first container and the at least one first dosing device are integrated into or combined as a single unit (combined as a single unit, Fig. 4) which is selectively replaceable in that they may be removed from the device for replacement (para. [0039]).
Therefore, 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 teachings of Dubief et al. wherein the at least one first container and the at least one first dosing device are integrated into or combined (White, at least combined, Fig. 4) as a single, selectively replaceable unit.
The person of ordinary skill in the art would have been motivated to make the container and dosing device replaceable in order to facilitate maintenance/replacing parts or cleaning (White, para. [0039]).
Claim 92 is rejected under 35 U.S.C. 103 as being unpatentable over Dubief et al. (US 20190274468) in view of Moretto (US 20190117009) and Wang et al. (US 20200297000) as applied to claim 85 above and in further view of Krup (US 3671020).
Regarding claim 92, Dubief et al. does not expressly disclose a stirrer.
However, Krup teaches a device for preparing a mixture of substances (for mixing beverages using powder and fluid/water, Abstract) and Krup further teaches wherein the device further comprises a stirrer (agitator 44) for mixing the solid component and the fluid within the mixing chamber (mixing chamber 13, Fig. 1).
Therefore, 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 teachings of Dubief et al. wherein the device further comprises a stirrer for mixing the solid component and the fluid within the mixing chamber.
The person of ordinary skill in the art would have been motivated to include a stirrer in order to achieve thorough mixing (Krup, col. 1, lines 45-47).
Claim 94 is rejected under 35 U.S.C. 103 as being unpatentable over Dubief et al. (US 20190274468) in view of Moretto (US 20190117009) and Wang et al. (US 20200297000) as applied to claim 85 above and in further view of Ding et al. (attached translation of CN 101570721A).
Regarding claim 94, Dubief does not disclose a sterile membrane.
However, Ding et al. discloses a system which is analogous art at least because it is reasonably pertinent to the problem of filtering a mixture (a beverage: soft pear fruit wine, Abstract) and Ding et al. further teaches wherein a sterile membrane (“filtered and sterilized with a sterile membrane filter equipped with 2 μm and 0.45 μm membranes”, para. [0007]) is used.
Therefore, 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 teachings of Dubief et al. wherein the filter is a sterile membrane.
The person of ordinary skill in the art would have been motivated to select a sterile membrane filter as a filter having pore sizes small enough to filter bacteria (Ding et al., 0.45 μm, para. [0007]).
Claim 95 is rejected under 35 U.S.C. 103 as being unpatentable over Dubief et al. (US 20190274468) in view of Moretto (US 20190117009) and Wang et al. (US 20200297000) as applied to claim 85 above and in further view of Geiger et al. (US 6250506).
Regarding claim 95, Dubief et al. does not expressly teach the container is deliverable pre-filled with the solid component.
However, Geiger et al. discloses a device for preparing a mixture (a beverage, the device having mixing chamber 46) having a container (pouch 20) for holding at least one solid component (powder, col. 1, line 64) and Geiger et al. discloses wherein the container is deliverable pre-filled with a solid component (col. 4, line 38), the container is configured for insertion and use as a first container within a device for metering and/or preparing a mixture of substances (dispensing device 1, a beverage, Abstract) and the container is configured to be operatively connected or connectable to a dosing device (dosing mechanism 42) for metering the solid component from the container.
Therefore, 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 teachings of Dubief et al. wherein the device includes a container for holding a solid component, wherein: the container is deliverable pre-filled with the solid component; the container is configured for insertion and use as the first container within the device of claim 85; and the container is configured to be operatively connected or connectable to a dosing device for metering the solid component from the container.
The person of ordinary skill in the art would have been motivated to include a pre-filled container in order to simplify refilling of solid component and prevent contamination (Geiger et al., “dry and clean”, col. 2, lines 36-43).
Claim 96 is rejected under 35 U.S.C. 103 as being unpatentable over Dubief et al. (US 20190274468) in view of Moretto (US 20190117009), Wang et al. (US 20200297000), Ding et al. (attached translation of CN 101570721A) as applied to claim 95 above and in further view of White (US 20130306672).
Regarding claim 96, Dubief et al. does not expressly disclose wherein the at least one first container and the at least one first dosing device are integrated into or combined as a single, selectively replaceable unit.
However, White discloses a device for preparing a mixture and White further teaches a first container (hopper 20) and a first dosing device (screw 26) and White teaches wherein the at least one first container and the at least one first dosing device are integrated into or combined as a single unit (combined as a single unit, Fig. 4) which is selectively replaceable in that they may be removed from the device for replacement (para. [0039]).
Therefore, 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 teachings of Dubief et al. wherein the at least one first container and the at least one first dosing device are integrated into or combined (White, at least combined, Fig. 4) as a single, selectively replaceable unit.
The person of ordinary skill in the art would have been motivated to make the container and dosing device replaceable in order to facilitate maintenance/replacing parts or cleaning (White, para. [0039]).
Claims 97 and 100 are rejected under 35 U.S.C. 103 as being unpatentable over Dubief et al. (US 20190274468) in view of Moretto (US 20190117009), and Wang et al. (US 20200297000) as applied to claim 85 above and in further view of Gardner (US 3880329).
Regarding claim 97, Dubief et al. does not expressly disclose a container for holding a fluid which is pre-filled with the fluid.
However, Gardner discloses a device for metering and/or preparing a mixture (beverage, title, device has mixing chamber 20, col. 3, line 12) with a container (can 40) for holding a fluid (syrup, col. 2, line 55), wherein: the container comprises a housing (shown below) that defines an interior space for holding the fluid; the container is deliverable pre-filled with the fluid (the canned product is understood to be pre-filled and sealed to prevent microbial growth during storage, col. 5, line 41-45 and the container is disposable, title); the container is configured for insertion and use as a second container within a device for preparing a mixture and the container is configured to be operatively connected or connectable to a fluid dosing device (connectable to a dosing device: pump 38, Fig. 1) as shown below:
PNG
media_image4.png
638
531
media_image4.png
Greyscale
Therefore, 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 teachings of Dubief et al. wherein the device includes a container for holding a fluid, wherein: the container comprises a housing that defines an interior space for holding the fluid; the container is deliverable pre-filled with the fluid; the container is configured for insertion and use as a second container within the device of claim 85; and
the container is configured to be operatively connected or connectable to a fluid dosing device.
The person of ordinary skill in the art would have been motivated to use pre-filled and sealed containers in order to ensure the contents are sterile (Gardner, col. 5, line 43).
Regarding claim 100, the combined teachings of the above-cited references for claim 97 disclose the fluid dosing device comprises at least one stroke system comprising a piston pump (Dubief et al., the dosing device/pump may be a piston pump. para. [0100], Gardner, col. 3, lines 1-3, pump 38 with piston 40, Fig. 1) comprising a piston; the piston is adapted to be deflected so that the fluid from the container can be dosed through deflection of the piston (Gardner describes operation of a piston pump, col. 3, lines 1-7); the container comprises at least one opening in fluid communication with the interior space (Dubief et al., Fig. 1, tank 101 has an opening for supply line 106 which feeds the pump 102, Gardner, opening at nipple 70, Fig. 2); and the stroke system (Dubief et al., pump 102, para. [0100], Gardner, pump 38 with piston 40, Fig. 1) is in fluid communication with the at the least one opening of the container (Dubief et al., Fig. 1, Gardner, Fig. 1).
Claims 98 and 99 are rejected under 35 U.S.C. 103 as being unpatentable over Dubief et al. (US 20190274468) in view of Moretto (US 20190117009), Wang et al. (US 20200297000) and Gardner (US 3880329) as applied to claim 97 above and in further view of Hengesbach et al. (US 20150289704) and Weibel et al. (US 20160213851).
Regarding claim 98, Dubief et al. does not explicitly disclose the second container and the at least one second dosing device are integrated into or combined as a single, selectively replaceable unit.
However, Hengesbach et al. discloses a device which is analogous art at least because it is reasonably pertinent to the problem of dosing liquids from containers (container 14) under sanitary conditions (Abstract) and Hengesbach et al. discloses a container (container 14) and a dosing device (piston pump 12) for fluid are integrated into or combined as a single (at least combined as shown in Fig. 1), selectively replaceable unit (the container is replaceable and disposable, para. [0029], and components of the dosing device/pump may be disposable, pars. [0048], including the nozzle 32 and piston 22 which connect to the container 14, Fig. 2).
Likewise, Weibel et al. discloses a device which is analogous art at least because it is reasonably pertinent to the problem of dosing fluids from containers (Abstract) under sanitary or sterile conditions (aseptic, para. [0001]) and Weibel et al. discloses a container (container 2) and dosing device (conveying device 5) wherein the container and dosing device are integrated into or combined as a single (at least combined, Fig. 1), selectively replaceable unit (disposable unit is desirable, para. [0008]).
Therefore, 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 teachings of Dubief et al. wherein the at least one second container and the at least one second dosing device are integrated into or combined as a single, selectively replaceable unit.
The person of ordinary skill in the art would have been motivated to combine the container and dosing unit as a selectively replaceable unit in order to maintain a sterile system (Weibel et al., para. [0008]) or to eliminate the need for cleaning surfaces in contact with fluid.
Regarding claim 99, the combined teachings of the above-cited references for claim 98 disclose the fluid dosing device comprises at least one stroke system comprising a piston pump (Dubief et al., the dosing device/pump may be a piston pump. para. [0100], Gardner, col. 3, lines 1-3, pump 38 with piston 40, Fig. 1, Hengesbach et al., piston pump 12, Fig. 1 and Fig. 2) comprising a piston; the piston is adapted to be deflected so that the fluid from the container can be dosed through deflection of the piston (Gardner describes operation of a piston pump, col. 3, lines 1-7); the container comprises at least one opening in fluid communication with the interior space (Dubief et al., Fig. 1, tank 101 has an opening for line 106 which feeds the pump 102, Gardner, opening at nipple 70, Fig. 2, Hengesbach et al., opening in container 14 connecting to inlet 38 of the dosing device, Fig. 2); and the stroke system (Dubief et al., pump 102, para. [0100], Gardner, pump 38 with piston 40, Fig. 1, Hengesbach et al., piston pump 12) is in fluid communication with the at the least one opening of the container (Dubief et al., Fig. 1, Gardner, Fig. 1, Hengesbach et al., Fig. 1 and Fig. 2).
Claim 102 is rejected under 35 U.S.C. 103 as being unpatentable over Ludwig et al. (US 20110013474) in view of Satyamurthy et al. (US 20180127355), Carll (US 6844186), and Schoeb (US 20090142827).
Regarding claim 102, Ludwig et al. discloses a preparation unit configured as a disposable component (disposable mixing vessel, Abstract) as shown below:
PNG
media_image5.png
828
881
media_image5.png
Greyscale
Ludwig et al. discloses the unit comprises a mixing chamber (vessel 2).
Ludwig et al. does not explicitly disclose the mixing chamber is configured to receive a solid component and a fluid. However, “it is well-settled that the material worked upon by an apparatus does not limit apparatus claims”. See MPEP 2115. Nonetheless, the device of Ludwig et al. would be fully capable of receiving a solid component and a fluid component (via material inlets 22).
Ludwig et al. further discloses a lid (shown above) arranged on the mixing chamber (Fig .1), the lid comprising an opening (surrounded by top flange 12, Fig. 1), wherein: a stirrer element (comprising shaft 6 and coupling 15) and the lid are designed either as a single integrated component or as separate components (the shaft 6 and the impeller/stirrer 10 spin relative to the lid using thrust bearings 74, para. [0049], so that the stirring element is a separate component), and a first end of the stirrer element is connected or connectable to a stirrer element motor (drive motor 80, Fig. 11A, para. [0049]), and a second end is connectable to a stirrer (impeller 10) extending within the mixing chamber (Fig. 1); the stirrer element passes through the opening of the lid or the stirrer is operated by the stirrer element via a magnetic coupling or via a mechanical coupling (the stirring element comprising shaft 6 and drive coupling 15 passes through the lid, Fig. 1, and is operated via a magnetic coupling, para. [0049]).
Ludwig et al. does not disclose the unit further comprises a sterile filter arranged downstream of the mixing chamber and Ludwig et al. does not explicitly disclose a collection container.
However, Ludwig et al. teaches the device may be used for mixing pharmaceuticals (para. [0003]) and Satyamurthy et al. discloses a device for the manufacture of a pharmaceutical (para. [0102]) which is analogous art at least because it is reasonably pertinent to the problem of maintaining sterile processing (para. [0025]) and Satyamurthy et al. discloses a preparation unit (including mixing vessel 80, Fig. 2B) further comprises a sterile filter (sterile filter 86, Fig. 2B) arranged downstream of the mixing chamber (mixing vessel 80); the filter is fluidically connected to or has an outlet to a collection container (vial 84, Fig. 2B).
Therefore, 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 teachings of Ludwig et al. wherein the preparation unit further comprises a sterile filter arranged downstream of the mixing chamber; the filter is fluidically connected to or has an outlet to a collection container.
The person of ordinary skill in the art would have been motivated to include a sterile filter downstream of the mixing chamber and a collection container in order to ensure a sterile mixture is discharged from the device and stored in a sterile container (Satyamurthy et al., sterile product vial 84) for storage and use such as for mixing and using a pharmaceutical for injection (Satyamurthy et al., para. [0102]).
Assuming, arguendo, that the top of Ludwig et al.’s mixing chamber does not constitute a lid; Carll discloses a disposable preparation unit (vessel 100, col. 2, line 67) wherein the mixing chamber comprises a lid (removable head plate 125).
Therefore, 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 teachings of Ludwig et al. wherein the mixing vessel comprises a lid.
The person of ordinary skill would have been motived to include a lid in order to make the preparation unit separable such as to place material into the mixing chamber or to facilitate installation of the stirring element. See In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961).
Assuming, arguendo, that the device of Ludwig et al. is not configured to receive a solid component; Schoeb discloses a disposable preparation unit (para. [0016]) with a mixing chamber (container 2 with mixing member 7) wherein the mixing chamber is configured to receive solids (via inlets 31-34, Fig. 1, para. [0061]).
Therefore, 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 teachings of Ludwig et al. wherein the mixing chamber is configured to receive solids.
The person of ordinary skill would have been motivated to configure the device for receiving solids in order to use the device for mixtures having solid ingredients.
Allowable Subject Matter
Claim 101 is 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.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art of record discloses various devices for metering or preparing a mixture of substances having containers and dosing devices for delivering the substances to a mixing chamber.
However, the prior art of record did not reasonably disclose, teach or otherwise suggest a device for metering or preparing a mixture of substances having containers and dosing devices for delivering substances to a mixing chamber for forming a mixture where the mixture is delivered from the mixing chamber to a collection container and wherein the device includes a fluid container with a first opening and a second opening wherein a fluid dosing device comprises first and second stroke systems each of which comprises a piston pump and wherein the first stroke system is in fluid communication with the first opening of the fluid container and the second stroke system is in fluid communication with the second opening of the fluid container.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Baenninger et asl. (US 20180222654) discloses a container with attached dispensing device which is disposable.
Donhowe (US 20030134007) discloses sterile filtering a beverage before placing the beverage in a can or bottle (para. [0073]).
Wilkie et al. (US 20200078433) discloses the use of sterile filters for preparing a beverage.
Zhu et al. (US 20200155714) discloses a sterile filter membrane (para. [0056]).
Wieslander et al. (US 20200069858) discloses a sterile filter membrane (para. [0049]).
Kampfe et al. (US 5450847) discloses a sterile filter (filter 46) downstream of a mixing chamber (chamber 20).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 PATRICK M MCCARTY whose telephone number is (571)272-4398. The examiner can normally be reached Monday - Thursday 9:00 AM - 5:00 PM.
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, Claire Wang can be reached at 571-270-1051. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/P.M.M./Examiner, Art Unit 1774
/CLAIRE X WANG/Supervisory Patent Examiner, Art Unit 1774