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 .
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 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.
Claim(s) 1, 4-5, 8-9,11-12,15,18, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gebauer (DE 102016218135), US 20200016552 A1 will be used as the English translation, further in view of Bohle (US 20200046610 A1) and Meyers (US2018/0149512 A1).
Regarding claim 1, Gebauer discloses a modular system (1) for the production of dosage-form bulk material in the form of dosage-form base materials or dosage forms [abstract], comprising:
At least one processing unit (4) which has a plurality of process stations (10,21, 38),
At least one container for receiving dosage-form bulk material [0020] comprising a normally closed connecting system (control system (5) controls stations 2-4 as depicted in figure 1);
An electronic system control device (5); and
At least one handling system (2) wherein at least one handling system transfers the containers between the process stations [0041].
Wherein of the process stations, one process station is designed as a feed station (2), one process station is designed as a mixing (3) or granulating station for carrying out a mixing or granulating procedure with regard to the dosage-form bulk material, [0046, 0053]
Wherein the modular system has an electronic system control device (5) that controls each handling system (2), wherein process data for controlling each handling system can be stored or are stored in the system control device, which process data define a specific method for producing dosage-form bulk material, wherein, when the method is carried out, at least one container is moved between a plurality of process stations by means of at least one handling system (Applicants claim language precludes the system has to be capable of, which process data define a specific method for producing dosage-form bulk material, wherein, when the method is carried out, at least one container is moved between a plurality of process stations by means of at least one handling system which Gebauer teaches [0053].
As for the one process station is designed as a discharge station Gebauer discloses “Thus, FIG. 1 shows that finished solid medicaments 22 may be taken both from the tablet press or the capsule filler 11 and from the coating device 10. The finished solid medicaments 22 are preferably output beyond the module boundary 8” [0050] which describes a discharge station. Further, analogous art, Bohle discloses discharging station “as a function of the signals of these detection devices, the system control unit 17 controls the deflector 5 in order to redirect the tablet flow selectively to one of the two discharge channels 6. Furthermore, the system control unit 17 controls the handling system 9 in order to effect handling of the individual containers 8 between a filling station 7, a storage space 11, and the coater 14 as well as from the coater 14 to the filling station 7 as well as have the handling system 9 actuate closure members at the dust-tight locks which are provided at the inlet openings and/or outlet openings of the individual devices of the system 1” [0032]. Bohle is essentially describing a discharge station. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have incorporated a discharge station in order to transport the finished product as taught by both Gebauer and Bohle.
Gebauer and Bohle do not explicitly disclose the handling system is designed as an industrial robot. However, analogous art, Meyers, discloses a dosage-dispensing system for powdery substances includes a robotic handler (2) [0012]. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have included an industrial robot, as taught by Meyers, into the system taught by Gebauer and Bohle for the benefit of providing an automated dosage dispensing system which can automatically adapt to different shapes and sizes of vials [0010]. One ordinary skill in the art would swap the handling system of Gebaur for the industrial robot taught by Bohle since (1) it is conventionally well known to use industrial robots and (2) it’s obvious to automate process to streamline process and cut costs, and (3), industrial robots increase the degree of freedom of movement of the handling system [0053].
Applicant amended the claim to add comprising a normally closed connecting system. However, Gebauer depicts a closed system in figure 1 (the systems are all connected to each other via control unit 5 [abstract] and therefore reads on closed connecting system).
Gebauer depicts wherein the feed station is designed as a container feed station (see figure 1), to receive at least one container filled with dosage-form bulk material (transfer from 2 to mixing device 3 connected to supply device in figure 1), and wherein the mixing (3) or granulation station comprises another of the normally closed connecting system to transfer the dosage-form bulk material from the at least one container to the mixing or granulation station where the dosage-form bulk material is mixed and/or granulated and returned to a container via the connecting system, and wherein the discharge station (4) is designed as a container discharge station, and wherein the discharge station (10, 11) is configured to receive the container comprising the dosage-form bulk material from the mixing or granulation station and to remove the container from the modular system (22).
Further, the Applicant is reminded that apparatus claims are not limited by the function they perform, as per MPEP §2114. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. As the apparatus of the prior art and the claimed apparatus are patentably indistinguishable in terms of structure, the apparatus of the prior art is reasonably expected to be able to perform the claimed functionalities.
As for the limitation, wherein the normally closed connecting system is closed when the at least one container is not connected to a process station and opens once the at least one container is coupled to the process station for dosage-form bulk material transfer from the at least one container to the process station, Gebauer, discloses the bifurcation (can read on container) can be ejected [0020] which one ordinary skill would understand it opening the normally closed connected system. Therefore, it would have been obvious to one having ordinary skill in the art to wherein the normally closed connecting system is closed when the at least one container is not connected to a process station and opens once the at least one container is coupled to the process station for dosage-form bulk material transfer from the at least one container to the process station for the benefit of preventing contamination of the transport network with inferior quality products is prevented.
Regarding claim 4, Gebauer discloses wherein the feed station and the discharge station are designed in the form of a structural unit, as a process station (see figure 1-2).
Regarding claim 5, Gebauer discloses wherein at least one processing unit has a process station designed as a container filling station [abstract, supply station reads on filling station].
Regarding claim 8, Gebauer discloses wherein at least one processing unit comprises a plurality of handle systems (Gebauer describes transport systems between the supply, mixing and final processing device 4 [0057-0059] which reads on plurality of handle system). Further, MPEP 2144.04 VI discloses In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). The court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have incorporated plurality of handle system since it have been held that a mere duplication of working parts of a device involves only routine skill in the art in order to streamline the process.
Regarding claim 9, Gebauer discloses wherein the at least one handling system is arranged in a central area of the processing unit and a plurality of process station is arranged around the central area (see figure 1).
Regarding claim 11, Gebauer does not explicitly discloses wherein the modular system has a plurality of processing units. MPEP 2144.04 VI discloses In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). The court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have incorporated plurality of processing units since it have been held that a mere duplication of working parts of a device involves only routine skill in the art in order to streamline the process.
Regarding claim 12, Gebauer depicts wherein at least two processing units of the modular system form a pair or processing units, the pair of processing units having a process station which can be assigned to each of the processing units which forms the pair of processing units (Gebauer depicts multiple filling stations 21, 37-40 in figure 1 which reads on pair of processing units).
Regarding claim 15, Gebauer discloses the modular system has a plurality of process stations designed as container filling station (Gebauer depicts multiple dosing units 13-16 in figure 1).
Regarding claim 18, Gebauer discloses the modular system comprises a process station designed as a storage station, and has an electronic storage control device [0016], wherein storage times specific to the dosage-form bulk material can be stored or are stored in the storage control device, the storage control device can record the start time of the storage of the at least one container filled with the dosage-form bulk material in the storage station, and, after the storage time has elapsed, can initiate the further processing of the at least one container filled with the dosage-form bulk material ( [0013, 0063]).
Regarding claim 20, Gebauer discloses wherein at least one process station has a sensor (quality sensor [0044]).
Response to Arguments
Applicant's arguments filed 8/13/2025 have been fully considered but they are not persuasive. Applicant argues Gebauer teaches processing stations are connected by piping. However, MPEP 2144.05 states it’s a prima facie case of obviousness when simple substitution is used. In this case, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have swap the handling system of Gebaur for the industrial robot taught by Bohle since (1) it is conventionally well known to use industrial robots and (2) it’s obvious to automate process to streamline process and cut costs, and (3), industrial robots increase the degree of freedom of movement of the handling system [0053].
Applicant further argues Gebaur is connected by piping and changing the piping would be a big design change. Examiner disagrees. Gebaur [0020] discloses changing the bifurcation (can read on container) in order to prevent contamination. Therefore, a container in Gebaur can be removed and does not require piping change. Further, [0044] of Gebaur discloses a manifold pipe can extend into the units but does not explicitly say all the containers are solely connected by pipes. Examiner notes that it has been held that disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971).
Applicant further argues Gebauer, Bohle, and Meyers are not analogous art. However, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Gebauer is directed to solid dosage form (abstract), Bohle is directed to forming pharmaceutical tablets, and Meyers is directed to powder dosage. All three arts are directed to producing pharmaceutical tablets.
Additionally, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Conclusion
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 FARAH N TAUFIQ whose telephone number is (571)272-6765. The examiner can normally be reached Monday-Friday: 8:00 am-4:30 pm.
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/FARAH TAUFIQ/ Primary Examiner, Art Unit 1754
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