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.
Claim Status
Claims 1-15 are pending in this application. Claims 1, 5, 8-11, and 14 were amended.
Examiner’s Note
The examiner would welcome an interview to clarify any of the various rejections seen below in order to expedite prosecution of the instant application.
Response to Arguments
Applicant’s arguments, see arguments/remarks, filed May 30, 2026, with respect to the rejections of claims 1-15 under 35 U.S.C. 112(b) have been fully considered and are persuasive. The rejections of claims 1-15 have been withdrawn. Applicant has corrected their range language as required. However, in performing some of these amendments applicant has introduced grammatical issues for which objections are noted under Claim Objections below.
Applicant's arguments filed May 30, 2026, with respect to the rejections of claims 1-15 under 35 U.S.C. 102 and 35 U.S.C. 103 have been fully considered but they are not persuasive. Applicant has amended independent claim 1 to require a plurality of workpiece carriers capable of receiving reactants (interpreted here as substances used in the production of pharmaceuticals and similar products, typically stored and transported in vials or syringes or similar containers) and capable of being mounted in storage spaces of a claimed storage device comprised by applicant’s overall product system. We find that primary reference Osborne (cited in rejections in the previous office action) anticipates and discloses the new limitations of the amended claim. The dependent claims have not been substantively amended except to overcome rejections under 35 U.S.C. 112(b) from the previous office action. As applicant’s traversal argument is based entirely on the matter of their amendments, we do not respond to them point by point here but rather direct the reader to the text of the rejection of claim 1, below.
Claim Objections
Claims 5, 8 and 14 are objected to because of the following informalities: in amending to correct the range-scope rejections from the previous action, applicant has replicated certain phrases in combination with disjunctive “or” clauses that do not further limit the claims.
Claim 5 recites, “…wherein the storage transport device comprises one or more rail-guided storage transport units by means of which one or more storage racks of the storage device are accessible or are accessible for storage and retrieval processes and for treatment processes and/or maintenance processes”. The boldface phrase “accessible or are accessible” is ungrammatical and moreover the disjunction it suggests is meaningless as the first broad disjunct includes the narrower condition of the second. The simplest correction is to redact the phrase “or are accessible” if at least one of the listed processes is meant to apply in all cases. If they are only optional, then the remainder of the sentence including and following “or are accessible” may be redacted.
Claim 8 recites, “…by means of which changing device different gripping units and/or carrier units can be mounted on one or more storage transport units of the storage transport device and/or on one or more handling units of the handling device, or by means of which changing device different gripping units and/or carrier units can be mounted on one or more storage transport units of the storage transport device and/or on one or more handling units of the handling device.” The underlined/boldface clause repeats the non-emphasized clause and can be redacted.
Claim 14 recites, “…wherein the production system comprises a cleaning device which can be supplied to workpiece carriers for cleaning same, or which can be supplied to workpiece carriers for cleaning same after the transport of an object by means of the corresponding workpiece carrier.” The boldface clause is unnecessary because it is an alternative further limitation of the non-boldface clause in an optional “or” disjunction and may be redacted. Alternatively, the non-boldface clause may be redacted along with “or” to require the terms of the boldface clause to apply.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-7, 9-11, and 13-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Osborne, Joel, US 2011/0067781 (hereinafter Osborne).
Regarding claim 1,
Osborne discloses:
A production system (automated workstation 10: fig. 1) for producing biological-pharmaceutical products (see abstract),
wherein the production system comprises: - a clean room region (areas 18, 20, 22, 24: fig. 1, [0090]);
- an airlock device (lock devices in areas 18 and 26: fig. 1, [0068], [0070]) for supplying an object from the surroundings of the production system into the clean room region and/or for removing an object from the clean room region;
- a handling device (robot R2: fig. 14) for moving the object within the clean room region;
- a storage device (storage area 20: fig. 1, [0082]-[0084]) which is arranged within the clean room region and which comprises a plurality of storage spaces (shelves, [0071]-[0073]) for receiving a plurality of objects.
wherein the production system comprises a plurality of workpiece carriers (matrix deck 104: figs. 6, 26) which serve to receive objects, wherein a plurality of workpiece carriers are designed as receiving boxes for receiving reactants (storing and combining substances in syringes, [0086]; storing the syringes themselves in the matrix deck, [0138]-[0143]), and wherein the receiving boxes can be mounted in storage spaces (shelves of storage area 20, [0071]-[0073]; matrix deck stored therein, [0141]) of the storage device.
Regarding claim 2,
Osborne discloses the limitations of claim 1 and also:
wherein the storage device comprises a storage transport device (robot R1: fig. 14, [0113]-[0115]) for transporting objects to the storage spaces and/or away from the storage spaces.
Regarding claim 3,
Osborne discloses the limitations of claim 2 and also:
wherein the storage transport device is a device different from the handling device.Osborne’s robots R1 (storage transport device) and R2 (handling device) are different devices.
Regarding claim 4,
Osborne discloses the limitations of claim 2 and also:
wherein the storage transport device comprises a rail-guided transport system and/or one or more free-moving transport vehicles.Osborne’s robot R1 is mobile on a rail per [0114]-[0115] and thus fulfills the first of the two options.
Regarding claim 5,
Osborne discloses the limitations of claim 2 and also:
wherein the storage transport device comprises one or more rail-guided storage transport units by means of which one or more storage racks of the storage device are accessible or are accessible for storage and retrieval processes and for treatment processes and/or maintenance processes.Osborne’s robot R1 is mobile on a rail per [0114]-[0115]. It accesses the storage area 20 per [0114], which storage area comprises shelves (racks) per [0071].
Regarding claim 6,
Osborne discloses the limitations of claim 2 and also:
wherein the storage transport device comprises one or more storage transport units (R1: fig. 14) designed as gantry conveyors.Osborne’s robot R1 conforms to our understanding of a “gantry conveyor” inasmuch as it is a robotic arm that is mobile on a rail per [0114]-[0115].
Regarding claim 9,
Osborne discloses the limitations of claim 2 and also:
wherein a cleaning device of the production system is associated with the storage transport device and/or the handling device, by means of which cleaning device at least one gripping unit and/or carrier unit of one or more storage transport units of the storage transport device and/or one or more handling units of the handling device can be cleaned after carrying out a storage process, transport process, handling process, maintenance process, and/or treatment process.Osborne discloses a cleaning system in [0064] which is used, after one or more working sessions (i.e. after any of the claimed processes) to “clean all the surfaces and all the contents” of the storage and preparation areas. Since robot R1 is a content of the storage area and comprises surfaces, it is cleaned as part of this process.
Regarding claim 10,
Osborne discloses the limitations of claim 2 and also:
wherein one or more objects are transferable from an airlock space of the airlock device to a storage transport device to one or more storage transport units of a storage transport device, by means of the handling device.Sun discloses in [0113]-[0117] that robots R1 (storage) and R2 (handling) can access a carousel 58 between the preparation area and storage area. Both these areas are in the airlock space. Robot R2 can pass objects via the carousel to robot R1 for storage and vice versa.
Regarding claim 7,
Osborne discloses the limitations of claim 1 and also:
wherein the handling device is a multi-axis robot arm or comprises same. Osborne’s robot R2 is disclosed in [0114]-[0116] to comprise a multi-axis robot arm.
Regarding claim 11,
Osborne discloses the limitations of claim 1 and also:
wherein the handling device comprises an airlock transport device by means of which one or more objects can be transported from an airlock space or an inlet airlock space, to a further airlock space or a transfer airlock space, and/or from an airlock space or a transfer airlock space, to a further airlock space or an outlet airlock space.Osbourne discloses at least two airlocks to their system, 18 and 26 in fig. 1, along with a transfer area 24 which is in a clean volume per [0090]. Handling device robot R2 is disclosed in [0117] to have access to both 18 and 26, thus performing the transfer of objects from one airlock to another.
Regarding claim 13,
Osborne discloses the limitations of claim 1 and also:
wherein the airlock device comprises a cleaning device ([0097]) for cleaning one or more workpiece carriers and/or for cleaning one or more workpiece carrier receptacles.Osborne discloses a matrix deck 104 (workpiece carrier) in [0143], a cleaning system in [0064], and a cleaning device in its airlock in [0097]. Per [0064], the cleaning system cleans all contents and surfaces, these contents including matrix decks per [0141].
Regarding claim 14,
Osborne discloses the limitations of claim 1 and also:
wherein the production system comprises a cleaning device which can be supplied to workpiece carriers for cleaning same, or which can be supplied to workpiece carriers for cleaning same after the transport of an object by means of the corresponding workpiece carrier.Osborne discloses a matrix deck 104 (workpiece carrier) in [0143], a cleaning system in [0064], and a cleaning device in its airlock in [0097]. Per [0064], after one or more working sessions (i.e. after any of the claimed processes including transport) the cleaning system cleans all contents and surfaces, these contents including matrix decks per [0141].
Regarding claim 15,
Osborne discloses the limitations of claim 1 and also:
wherein the storage device comprises one or more storage racks and/or one or more storage space areas which each have a plurality of storage spaces, wherein reactants and/or tools and/or consumable materials can be stored in or removed from the storage spaces by means of the storage transport device.Osbourne discloses a plurality of storage units in storage area 20 in [0082]-[0084] for various of these stored item types including consumables. Robot R1 accesses these stored items in [0114]-[0116].
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 8 is rejected under 35 U.S.C. 103 as being unpatentable over Osborne in view of Eliuk, et al., US 2015/0250678 (hereinafter Eliuk).
Osborne discloses the limitations of claim 2 but not:
wherein a changing device of the production system is associated with the storage transport device and/or the handling device, by means of which changing device different gripping units and/or carrier units can be mounted on one or more storage transport units of the storage transport device and/or on one or more handling units of the handling device, or by means of which changing device different gripping units and/or carrier units can be mounted on one or more storage transport units of the storage transport device and/or on one or more handling units of the handling device for carrying out different storage processes, transporting processes, handling processes, maintenance processes and/or treatment processes by means of the corresponding storage transport unit and/or handling unit.Osborne does not disclose interchangeable or replaceable grippers, end-effectors or other robotic tools.
Eliuk, an invention in the field of pharmaceutical manufacture automation, teaches the limitation:
wherein a changing device of the production system is associated with the storage transport device and/or the handling device, by means of which changing device different gripping units and/or carrier units can be mounted on one or more storage transport units of the storage transport device and/or on one or more handling units of the handling device, or by means of which changing device different gripping units and/or carrier units can be mounted on one or more storage transport units of the storage transport device and/or on one or more handling units of the handling device for carrying out different storage processes, transporting processes, handling processes, maintenance processes and/or treatment processes by means of the corresponding storage transport unit and/or handling unit.Eliuk teaches in [0122] that a gripper finger exchange station may be employed in the processing chamber to swap out gripper fingers for different robotic tasks and applications.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the system of Osborne, wherein a changing device of the production system is associated with the storage transport device and/or the handling device, by means of which changing device different gripping units and/or carrier units can be mounted on one or more storage transport units of the storage transport device and/or on one or more handling units of the handling device, or by means of which changing device different gripping units and/or carrier units can be mounted on one or more storage transport units of the storage transport device and/or on one or more handling units of the handling device for carrying out different storage processes, transporting processes, handling processes, maintenance processes and/or treatment processes by means of the corresponding storage transport unit and/or handling unit, as taught by Eliuk because different robotic tasks may be better performed by one gripper, end-effector, or EOAT than another and because robots with interchangeable or swappable end-effectors are widespread and commonplace in the art.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Osborne in view of Deutschle, et al., US 2020/0290756 (hereinafter Deutschle).
Osborne discloses the limitations of claim 2 but not all aspects of:
wherein the storage transport device and/or the handling device each comprise one or more workpiece carrier receptacles for receiving and transporting one or more workpiece carriers.Osborne does not disclose the claimed receptacles for workpiece carriers. However, its robotic arms are capable of transporting such receptacles.
Deutschle, an invention in the field of pharmaceutical packaging, teaches the limitation:
wherein the storage transport device and/or the handling device each comprise one or more workpiece carrier receptacles for receiving and transporting one or more workpiece carriers.Deutschle teaches the claimed receptacles in fig. 4D in the form of transport and packaging containers 10 that receive and transport workpiece carriers in the form of supports 20 that in turn carry workpieces in the form of cartridges 8. As seen in fig. 5 these containers 10 are themselves comprised by the processing system 50 with its various transport, storage, and handling devices.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the system of Osborne wherein the storage transport device and/or the handling device each comprise one or more workpiece carrier receptacles for receiving and transporting one or more workpiece carriers, as taught by Deutschle because transporting receptacles containing multiple workpiece carriers is plainly more efficient than transporting individual workpiece carriers, and because manufacturing and storage facilities in all commercial and industrial arts have long transported such containers via receptacles in conveying devices.
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.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2006/0257999 and US 2019/0315004, disclosed in applicant’s IDS of June 17, 2026, bear strongly on the instant application even though they were not selected as teaching references in this office action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURENCE RAPHAEL BROTHERS whose telephone number is (703)756-1828. The examiner can normally be reached M-F 0830-1700.
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, Ernesto Suarez can be reached at (571) 270-5565. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERNESTO A SUAREZ/Supervisory Patent Examiner, Art Unit 3655
LAURENCE RAPHAEL BROTHERS
Examiner
Art Unit 3655A
/L.R.B./Examiner, Art Unit 3655
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