DETAILED ACTION
This action is a non-final, first office action on the merits in response to applicant’s communication filed on 1/17/2024, wherein claims 1-10 are currently pending.
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
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d) based upon an application filed in Germany. The certified copy has been filed in parent Application No. 10 2021 207 747.1, filed on July 20, 2021.
Information Disclosure Statement
The multiple information disclosure statements (IDS) submitted on 4/23/2024, 7/15/2025, and 3/17/2026 are being considered by the examiner.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: Claims 1, 4, and 8 mention a “sluice device” with no mention of it in the specification.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “sluice device” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim 1 invokes 112(f) describing “a handling device for moving the object within the clean-room region.” It is understood in view of applicant’s specification and drawings that the aforementioned can be: “[0108] The handling device can have a distribution unit via which objects to be transported can be supplied to the storage transport device and/or can be received thereby. Optionally, the distribution unit can be designed as an, or as part of an, airlock transport device, or can be assigned to such a device… [0119] The handling device can be a multi-axis robot arm or can comprise such. [0120] Additionally or alternatively, it can be provided that the handling device is a pick-and-place robot or a cable robot or comprises such a robot, and/or that the handling device is a suitable gripper actuator, or comprises such a gripper actuator, configured on a planar rotor.”
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 1-10 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, for example, claim 1 recites the broad recitation “method for producing a product,” and the claim also recites “in particular a biological-pharmaceutical product” which is the narrower statement of the range/limitation. Likewise, claim 3, 5, and 7-10 employ a similar construction using the phrase “in particular.” The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claim(s).
Claim 1 also recites in its body “the reactant is stored in a storage location of a storage device of the production facility.” The preamble already recites “a storage device which is arranged within the clean-room region and comprises a plurality of storage locations.” It is unclear whether “a storage device” and “a storage location” in the body refer to the previously recited storage device and one of its plurality of storage locations, or to a newly introduced, different storage device and location. The claim is therefore indefinite for lack of clear antecedent basis.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-5, 7, 8, and 10 are rejected on the ground of nonstatutory (obviousness-type) double patenting as being unpatentable over claims 1, 4, 6, and 8 of US Patent No. 12,649,603 B2, hereinafter ‘603 patent,” with the specific patent claim(s) relied upon for each instant claim identified below. Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of the ‘603 patent in view of Osborne (WO 2009147252 A1). Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of the ‘603 patent in view of Krones (EP 3815877 A1). Claim 9 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of the ‘603 patent in view Reinhardt et al. (EP 2457550 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are method claims that recite more steps than, and use terminology that does not literally match, the apparatus claims of the ‘603 patent; accordingly, for each instant claim the limitations that match and are anticipated by the identified claim(s) are stated on the record, together with what is taught and obvious in view of the patent claim(s).
Instant Claim 1 over Claim 6 of the ‘603 Patent
Claim 1 of US Patent No. 12,649,603 B2 is directed to a production plant for producing biological-pharmaceutical products comprising a clean room region, a lock device configured for feeding an object into the clean room region and/or removing an object from the clean room region, a handling device configured to move the object within the clean room region, and a storage device arranged within the clean room region comprising a plurality of storage locations for receiving a plurality of objects; and an unpacking device configured to unpack objects to be fed to the clean room region, including a plurality of unpacking units configured to unpack different types of objects and/or packaging and/or remove different types of packaging from the objects. Claim 6 of ‘603 patent recites that one or more unpacking units are designed for unpacking reactants.
The following limitations of instant claim 1 match and are anticipated by claim 1 of the ‘603 patent:
The recited “production facility,” in particular for producing a biological-pharmaceutical products – matched by the patented production plant for producing biological-pharmaceutical products;
The recited “clean-room region” – matched by the patented clean room region;
The recited “sluice device for feeding an object from an environment of the production facility into the clean-room region and/or for removing an object from the clean-room region” – matched by the patented lock device configured to feed an object from an environment of the production plant into the clean room region and/or to remove an object from the clean room region, the recited “sluice device” and the patented “lock device” being different terminology for the same structure performing the same recited function;
The recited “handling device for moving the object within the clean-room region” – matched by the patented handling device configured to move the object within the clean room region; and
The recite “storage device which is arranged within the clean-room region and comprises a plurality of storage locations for receiving a plurality of objects” – matched in substance by the patented storage device arranged within the clean room region comprising a plurality of storage locations for receiving a plurality of objects.
The instant claim differs from the patented claims in that it recites method steps of operating the facility, selecting one of a plurality of production programs, introducing a reactant into the sluice device, automatically transporting the reactant into the clean-room region and storing it in a storage location of the storage device, and automatically carrying out one or more treatment processes on the reactant, whereas the patented claims recite the plant itself. The patented claims additionally recite an unpacking device, which the instant claim does not recite; the instant claim is broader in that respect.
The recited method steps are taught by and obvious in view of claims 1 and 6 of the ‘603 patent because they recite the normal and expected use/operation of the patented plant. Claim 6 of the ‘603 patent expressly contemplates reactants being fed into the plant (one or more unpacking units designed for unpacking reactants); introducing the reactant through the patented lock device is the recited introduction into the sluice device; moving the reactant within the clean room region by the patented handling device to one of the patented plurality of storage locations is the recited automatic transporting and storing; and processing the reactant within the patented clean room region of a plant for producing biological-pharmaceutical products, in accordance with a production program selected for the product to be produces, is the recited automatic carrying out of one or more treatment processes.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed intention to use the production plant of the claims 1 and 6 of the ‘603 patent to perform the claimed production method because the instant method recites the normal expected use/operation of the claimed production plant, a method of using a patented apparatus in its normal and expected manner is not patentably distinct from the apparatus claims.
Instant Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of the ‘603 patent in view of Osborne (WO 2009147252 A1)
Claim 1 of the ‘603 patent discloses the production plant, including the handling device configured to move the object within the clean room region and the storage device within the clean room region, as set forth in instant claim 1 above.
Claim 1 of the ‘603 patent does not recite that one or more treatment processes are carried out fully automatically until the product to be produce from the reactant is completed.
However, Osborne teaches one or more treatment processes are carried out fully automatically until the product to be produce from the reactant is completed (See Fig. 1, Page 1, Line 28: “The present invention relates to an automated workstation for preparing and supplying such final products which ensures the greatest possible safety for the patients, in particular regarding the guarantee of the composition of the final product and the dosage”); (See also Page 21, Line 14: “As diagrammatically illustrated in Figures 52A to 52D, and by means of a simple robot or programmable logic controller with three axes, it is possible to perform the four main operations consisting in adding diluents to the vial F, verifying the weight of the quantity of diluent added to the vial, mixing the powder and diluents, and transferring the liquid with the medicinal substances from the vial into the container of the final product such as the syringe S”).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed intention to operate the production plant of claim 1 of the ‘603 patent so that the treatment processes are carried out fully automatically until the product is completed, as taught by Osborne, in order to obtain the throughput, repeatability, and reduced-contamination benefits of fully automated operation of the patented plant.
Instant Claim 3 over Claim 1 of the ‘603 Patent
Instant claim 3 recites that one or more, in particular all, treatment processes are carried out at the storage location. Claim 1 of the ‘603 patent recites the storage device arranged within the clean room region comprising a plurality of storage locations for receiving a plurality of objects, the handling device being configured to move the object within the clean room region.
Claim 1 of the ‘603 patent does not recite that one or more, in particular all, treatment processes are carried out at the storage location.
However, carrying out one or more treatment processes on the reactant at the storage location at which it is received is an obvious manner of operating the patented plant.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed intention to operate the production plant as stated because the patented storage locations are within the same clean room region in which production takes place, and performing one or more of the treatment processes where the object is stored, rather than first relocating it, yields the predictable benefit of reduced handling.
Instant Claim 4 over Claim 1 of the ‘603 Patent
Instant claim 4 recites that the product produced is removed from the storage location and automatically transported to the sluice device for removal from the production facility.
Claim 1 of the ‘603 patent recites the lock device being configured to remove an object from the clean room region and the handling device being configured to move the object within the clean room region. Removing the produced product from the storage location by the patented handling device and automatically transporting it to the patented lock device (sluice) for removal from the production facility matches the recited removal function of the patented lock device.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed intention to operate the production plant and produce a product as mentioned above and for the reasons stated as it is the normal and expected use and operation of the patented plant.
Instant Claim 5 over Claim 1 of the ‘603 Patent
Instant claim 5 recites that the product is filled and or packaged before it is removed.
Claim 1 of the ‘603 patent recites the plant for producing biological pharmaceutical products, including the lock device configured to remove an object from the clean room region.
Filling and/or packaging the biological-pharmaceutical product within the clean room region before it is removed through the patented lock device is taught by and obvious in view of claim 1 because a biological-pharmaceutical product must be contained for removal and distribution, and completing the product in filled/packaged form within the clean room region before removal is the normal and expected manner of producing biological pharmaceutical products with the patented plant.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed intention to operate the production plant and produce a product as mentioned above and for the reasons stated as it is the normal and expected use and operation of the patented plant.
Instant Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of the ‘603 patent in view of Winzinger (EP 3815877 A1)
Instant claim 6 recites that one or more vessels, receptacles and or tools which have been used to produce the product remain at least partially within the clean-room region after completion of the product, are cleaned and sterilized, and are subsequently reused for producing a further product.
Claim one of the ‘603 patent recites the storage device arranged within the clean-room region comprising a plurality of storage locations for receiving a plurality of objects, and claim 5 recites that the lock device comprises a cleaning device, establishing cleaning capability within the patented plant.
The patented claims do not recite that vessels, receptacles and or tools used to produce the product remain within the clean room region, are cleaned and sterilized, and are subsequently reused for producing a further product.
However, Winzinger discloses that exchangeable components remain within the clean Room (clean room 50) and are included in an automatic cleaning and sterilization process. The components are stored by the robot arm (robot arms 11 and 31) in a magazine (magazines 20 and 21) in the clean room, oriented so that cleaning and sterilization medium reaches their surfaces and thereby available for subsequent production without transfer through locks. (See also Winzinger, Pars. [0027], [0033], and [0047-0048] as cited below).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, with a reasonable expectation of success to operate the production plant of claims 1 and 5 of the ‘603 patent such that vessels, receptacles and/or tools used to produce the product remain within the clean-room region at the patented storage locations, are cleaned and sterilized, and are reused for producing a further product, as taught by Krones, in order to reduce repeated transfer of components through the patented lock device, maintain sterile conditions, and keep the components available for subsequent production.
Instant Claim 7 over Claim 6 of the ‘603 Patent
Instant claims 7 recites that required consumables, in particular consumable materials and/or tool consumables are stocked up within the clean-room region.
Claims 6 of the ‘603 patent recites that one or more further unpacking units are designed for unpacking tools and/or consumables, and claim 1 recites the storage device arranged within the clean-room region comprising a plurality of storage locations for receiving a plurality of objects.
The recited stocking of required consumables within the clean-room region matches and is anticipated in substance by the patented plant’s handling of tools and/or consumables (claim 6) received in the storage device within the clean-room region (claim 1). Feeding, unpacking, and storing the tools/consumables in the patented storage device so that they are stocked for production is the normal and expected use/operation of the patented plant.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed intention to operate the production plant and produce a product as mentioned above and for the reasons stated as it is the normal and expected use and operation of the patented plant.
Instant Claim 8 over Claim 6 of the ‘603 Patent
Instant Claim 8 recites that the consumables are automatically transported into the clean-room region via the sluice device and stored in one or more storage locations of the storage device.
Claim 1 of the ‘603 patent recites the lock device configured to feed an object into the clean-room region, the handling device configured to move the object within the clean-room region, and the storage device comprising the plurality of storage locations. Claim 6 of the ‘603 patent recites unpacking units designed for unpacking tools and/or consumables.
Feeding the consumables through the patented lock device and moving them by the patented handling device to the patented storage locations matches the recited functions of those patented structures and is the normal and expected use and operation of the patented plant. It is therefore taught by and obvious in view of claims 1 and 6.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed intention to operate the production plant and produce a product as mentioned above and for the reasons stated as it is the normal and expected use and operation of the patented plant.
Instant Claim 9 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of the ‘603 patent in view Reinhardt et al. (EP 2457550 A1)
Instant claim 9 recites that a quantity of the consumable stocked up within the clean room-region is monitored and when the quantity falls below a prespecified minimum quantity, the supply is replenished by supplying the required consumables, in particular via an indication or a warning message at an operating unit.
Claim 1 of the ‘603 patent recites the storage device within the clean-room region for receiving a plurality of objects, and claim 7 recites that the unpacking device comprises a detection device and a control device by means of which a type of the object to be unpacked can be determined, establishing automated detection and control over the objects fed into the patented plant.
The patented claims do not recite monitoring a quantity of the consumables, replenishing the supply when the quantity falls below a prespecified minimum quantity, or an indication or warning message at an operating unit.
However, Reinhardt et al. discloses monitoring inventory and replenishing/notifying -- the cell exchanging historical, current, and anticipated inventory information, ordering automatically to maintain a minimum level of inventory of certain inputs, and notifying the technician what inputs need to be loaded, with the flat panel monitor (flat panel monitor 202) displaying a message to the operator when a predetermined condition has occurred (APAS cell 100; inventory racks 210; Figure 2). (See also Pars. [0015] and [0019] as cited below).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention with a reasonable expectation of success to operate the production plant of claims 1 and 7 of the ‘603 patent such that the quantity of consumables stocked in the patented storage device is monitored and the supply replenished when it falls below a prespecified minimum, with an indication or warning message at an operating unit, as taught Reinhardt et al., in order to maintain required input supplies and avoid interruption of production by the patented plant.
Instant Claim 10 over Claim 6 of the ‘603 Patent
Instant claim 10 recites that a plurality of products, in particular a plurality of different products, are simultaneously produced within the clean-room region.
Claim 1 of the ‘603 patent recites the storage device comprising a plurality of storage locations for receiving a plurality of objects, and the unpacking device comprising a plurality of unpacking units being configured to unpack different types of objects. Claim 6 recites unpacking units designed for unpacking reactants and further unpacking units designed for tools and or consumables. The patented plant is thus configured to receive, hold, and handle a plurality of different objects concurrently within the clean-room region.
Producing a plurality of products, including different products, concurrently within the clean-room region is taught by and obvious in view of claims 1 and 6 because operating the patented plant on the plurality of objects it is configured to concurrently receive and store is its normal and expected use/operation, with the predictable benefit of increased throughput.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed intention to operate the production plant and produce a product as mentioned above and for the reasons stated as it is the normal and expected use and operation of the patented plant.
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.
Claims 1-5 and 7-10, as best understood in view of the relevant 112(b) rejections, are rejected under 35 U.S.C. 103 as being unpatentable over Osborne (WO 2009147252 A1) in view Reinhardt et al. (EP 2457550 A1), hereinafter “Reinhardt.”
Regarding Claim 1, Osborne discloses:
[A] Method for producing a product, in particular a biological-pharmaceutical product, by means of a production facility, in particular a production facility (See Abstract: “an automated workstation (10) for the preparation, from different substances, each of which is contained in a vessel, of a final product for medical or pharmaceutical use”),
which comprises the following:
a clean-room region (See Abstract, Fig. 1: “an area (20) for storing the filled vessels and containers … a transfer area (24), an area (22) for preparing the final products which communicates at least with said storage area (20) via said transfer area (24)”); The collective clean-room region maps to Osborne’s elements listed above;
a sluice device for feeding an object from an environment of the production facility into the clean-room region and/or for removing an object from the clean-room region (See Abstract, Fig. 1: “a loading area (18) comprising rapid decontamination means … a lock device (26) for unloading the final products from the workstation (10)”); Loading area 18 maps to the feed-side sluice device while lock device 26 maps to the removal-side sluice;
a handling device for moving the object within the clean-room region (See Abstract: “at least one robot or one programmable logic controller for handling the objects contained in the storage area (20) and/or in the preparation area (22)”); (See also Page 2, Line 30: “the workstation comprises at least two robots (R1, R2), or programmable logic controllers for handling objects, one of which is arranged in the storage area and the other one of which is arranged in the preparation area”), and
a storage device which is arranged within the clean-room region and comprises a plurality of storage locations for receiving a plurality of objects (See Page 7, Line 10: “As illustrated diagrammatically in Figure 1, the storage area 20 comprises groups 28 of shelves, some of which can belong to a refrigerated area forming refrigerated storage means arranged in the storage area.”),
wherein the method comprises the following:
introducing a reactant into a sluice device of a production facility (See Abstract, Fig. 1: “a lock device for introducing the vessels and containers into the loading area (18)”); The recited reactant is construed as a starting substance subjected to one or more treatment processes, and Osborne on Page 1, Line 20 discloses that “The final product results from a preparation operation starting from different substances contained in vessels such as vials and/or flexible bags … The present invention relates to an automated workstation for preparing and supplying such final products which ensures the greatest possible safety for the patients, in particular regarding the guarantee of the composition of the final product and the dosage”);
automatically transporting the reactant into a clean-room region of the production facility, wherein the reactant is stored in a storage location of a storage device of the production facility, which location is located within the clean-room region (See Page 8, Line 9: “The loading area 18, with its lock device function for introduction into the storage area 20, is used to introduce all the elements, components and consumables (disposables) into the storage area 20”); (See also Page 13, Line 26: “After identification, and by means of the robot, the elements and components are stored in the different areas and storage means that are defined”); and
automatically carrying out one or more treatment processes on the reactant (See Page 8, Line 33: “The preparation area 22 is the one in which the final product preparation phase is implemented, in particular by mixing liquid products inside the vials, by weighing them, by transferring the liquid from a vial to a final container such as an intravenous flexible IV bag or a syringe. It is also where adding diluents and decontaminating is carried out”); (See also Page 21, Line 14: “As diagrammatically illustrated in Figures 52A to 52D, and by means of a simple robot or programmable logic controller with three axes, it is possible to perform the four main operations consisting in adding diluents to the vial F, verifying the weight of the quantity of diluent added to the vial, mixing the powder and diluents, and transferring the liquid with the medicinal substances from the vial into the container of the final product such as the syringe S”).
Osborne further discloses computer control that reads labels to interpret the medicinal substance and concentration needed to prepare the prescribed dose (See Page 13, Line 22: “The software of the computer system managing the installation as a whole and the workstation also makes it possible to read the inscriptions on the label and thus to interpret the appropriate nature of the medicinal substance and its concentration that must be used to prepare the prescribed dose”).
However, Osborne does not appear to disclose selecting one of a plurality of production programs for producing one of a plurality of products that can be produced by means of the production facility.
In the same field of endeavor, Reinhardt teaches:
selecting one of a plurality of production programs for producing one of a plurality of products that can be produced by means of the production facility (See Paragraph [0316]: “In some examples, one drug may be associated with multiple reconstitution profiles. A particular profile may be selected from the multiple profiles based on the requested drug order dosage. For example, Cefazolin 10 Gram bulk vial (e.g., Pharmaceutical Partners of Canada Inc., DIN 02237140) may be associated with two drug profiles for injection. A first profile to produce 200 MG/ML doses may include diluting with 45 ml of sterile water. A second profile to produce 100 MG/ML doses may include diluting with 96 ml of sterile water”).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the automated pharmaceutical preparation method of Osborne to incorporate the selectable reconstitution/production profiles of Reinhardt in order to select and execute an appropriate automated preparation process based on the requested product or dosage. Such modification would have amounted to combing prior-art elements according to known methods to yield the predictable result of selectable, automated production of different pharmaceutical products, with a reasonable expectation of success given that both references operated computer-controlled robotic compounding processes on vials, diluent, and containers. See KSR; MPEP § 2143(I)(A).
Regarding Claim 2, Osborne in view of Reinhardt discloses:
The method according to Claim 1, wherein one or more treatment processes are carried out fully automatically until a product to be produced from the reactant is completed (See Fig. 1, Page 1, Line 28: “The present invention relates to an automated workstation for preparing and supplying such final products which ensures the greatest possible safety for the patients, in particular regarding the guarantee of the composition of the final product and the dosage”); (See also Page 21, Line 14: “As diagrammatically illustrated in Figures 52A to 52D, and by means of a simple robot or programmable logic controller with three axes, it is possible to perform the four main operations consisting in adding diluents to the vial F, verifying the weight of the quantity of diluent added to the vial, mixing the powder and diluents, and transferring the liquid with the medicinal substances from the vial into the container of the final product such as the syringe S”).
Regarding Claim 3, Osborne in view of Reinhardt discloses:
The method according to Claim 1, wherein one or more, in particular all, treatment processes
are carried out at the storage location (See Page 13, Line 22: “It is in the storage area 20 that a part of the preparation method is carried out, and in particular the final identification of the vials, the labelling of the containers for the prepared final products, the assembly of the adaptors on the vials, the visual recognition of certain elements, the decontamination by gaseous means, or bio-decontamination, of the external surfaces of everything contained in the storage area, weighing, etc.”).
Regarding Claim 4, Osborne in view of Reinhardt discloses:
The method according to Claim 1, wherein the product produced in this way is removed
from the storage location and is automatically transported to the sluice device for removal from the production facility (See Abstract, Fig. 1: “a lock device (26) for unloading the final products from the workstation (10)”); (See Page 25, Line 39: “Since the systems and the workstation are entirely automated, certain customers may ask for additional quality control tests to be carried out so as to be certain that the cytotoxic drug prepared at the dose for the patient is the correct drug and is delivered in the correct concentration”).
Regarding Claim 5, Osborne in view of Reinhardt discloses:
The method according to Claim 4, wherein the product is filled and/or packaged before it is removed, in particular filled and/or packaged ready for use (See Page 8, Line 33: “The preparation area 22 is the one in which the final product preparation phase is implemented, in particular by mixing liquid products inside the vials, by weighing them, by transferring the liquid from a vial to a final container such as an intravenous flexible IV bag or a syringe).
Regarding Claim 7, Osborne in view of Reinhardt discloses:
The method according to Claim 1, wherein, for producing the product and/or for producing a plurality of different products, required consumables, in particular consumable materials and/or tool consumables, are stocked up within the clean-room region device (See Page 8, Line 9: “The loading area 18, with its lock device function for introduction into the storage area 20, is used to introduce all the elements, components and consumables (disposables) into the storage area 20”); (See also Fig. 1); (See also Page 8, Line 13: “The storage area 20 is in particular the one containing all the vessels, such as vials, containing for example the cytotoxic products that are stored therein with the other consumable elements or components - that is, all the components or elements other than the containing vessels and the substances - which are required for the operation of the workstation, for the preparation of the final products, such consumables being, for example, labels and/or ribbons for the printer. Of course, the storage area 20 also stores syringes of different sizes, needle-less adaptors or pins for vials, flexible bags, in particular of the intravenous IV type, universal supports for handling the vials and bags, cleaning equipment, gloves and envelopes (jackets) for the robots, absorbent mats for the shelving units, connecting pins, etc.”).
However, Osborne does not appear to disclose wherein consumable materials and/or tool consumables, are stocked up within the clean-room region before the product to be produced is selected.
In the same field of endeavor, Reinhardt teaches:
Wherein consumable materials and/or tool consumables, are stocked up within the clean-room region before the product to be produced is selected (See Paragraph [0019]: “In some implementations, the inventory racks 210 may be pre-loaded (e.g., off-line in advance) with the inventory 212 needed for input to the APAS cell 100. For example, pre-loaded racks of commonly used inputs (e.g., saline IV bags) may be prepared to satisfy anticipated, expected, or planned compounding production orders”).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Osborne’s system to pre-load/stock the required consumables and inventory within the clean-room region, as taught by Reinhardt, in order to ensure that required vessels, materials, and other consumables are available for automated pharmaceutical production. Such modification would have amounted to combing a known inventory-stocking technique with the known automated pharmaceutical production workstation of Osborne to yield predictable results, with a reasonable expectation of success given that both references store compounding consumables in racks/shelves within the controlled environment for robotic access. See KSR; MPEP § 2143(I)(A).
Regarding Claim 8, Osborne in view of Reinhardt discloses:
The method according to Claim 7, wherein the consumables are automatically transported
into the clean-room region via the sluice device and are stored there in particular in one or more storage locations of the storage device (See Page 8, Line 9: “The loading area 18, with its lock device function for introduction into the storage area 20, is used to introduce all the elements, components and consumables (disposables) into the storage area 20”); (See also Fig. 1); (See also Page 25, Line 39: “Since the systems and the workstation are entirely automated”).
Regarding Claim 9, Osborne in view of Reinhardt discloses:
The method according to Claim 7 as set forth above.
However, Osborne does not appear to disclose wherein a quantity of the consumables stocked up within the clean-room region is monitored, and in that, when the quantity falls below a prespecified minimum quantity, the supply is replenished by supplying the required consumables, in particular via an indication or a warning message at an operating unit.
In the same field of endeavor, Reinhardt teaches:
wherein a quantity of the consumables stocked up within the clean-room region is monitored, and in that, when the quantity falls below a prespecified minimum quantity, the supply is replenished by supplying the required consumables, in particular via an indication or a warning message at an operating unit (See Paragraph [0019]: “The computer device 208 may communicate with the APAS cell 100, and each may be programmed to process and/or exchange information about historical, current, and anticipated inventory, supply schedules, and demand information. The information may be used to prioritize, schedule, and order inventory to respond to and satisfy production input requirements for one or more APAS cell 100 systems, for example. In some cases, the APAS cell 100 may coordinate with a hospital inventory control system to place orders automatically, for example, to maintain a minimum level of inventory of certain inputs or outputs of the APAS cell 100 based on historical and expected demand information”); (See also Paragraph [0015]: “ the flat panel monitor 202 can be used in the monitoring of the status and alarm conditions of the APAS by displaying, for example, a message to the operator when a predetermined condition has occurred”).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Osborne’s system to monitor consumable quantity and provide replenishment indications/warnings at an operating unit, as taught by Reinhardt, in order to maintain required input supplies and avoid interruption of automated pharmaceutical production. Such modification would have amounted to applying a known inventory-monitoring and operator-notification technique to the known automated pharmaceutical workstation of Osborne to yield predictable results, with a reasonable expectation of success because the modification applies Reinhardt’s monitoring/notification function to Osborne’s already computer-managed workstation. See KSR; MPEP § 2143(I)(C),(D).
Regarding Claim 10, Osborne in view of Reinhardt discloses:
The method according to Claim 1, including the production of products concurrently/simultaneously in process within the clean-room region in view of the provided two robots arranged in different areas of the isolated chamber (See Page 2, Line 30: “the workstation comprises at least two robots (R1, R2), or programmable logic controllers for handling objects, one of which is arranged in the storage area and the other one of which is arranged in the preparation area”). The recitation “simultaneously produced within the clean-room region” is given its broadest reasonable interpretation as products being in production within the clean-room region at overlapping times; the limitation does not require that the separate products reach completion at the same instant.
However, Osborne does not appear to disclose wherein a plurality of products, in particular a plurality of different products, are simultaneously produced within the clean-room region.
In the same field of endeavor, Reinhardt teaches:
wherein a plurality of products, in particular a plurality of different products, are produced within the clean-room region (See Paragraph [0020]: “the APAS cell 100 may be operated in a batch mode to produce some number of substantially similar outputs”); (See also Paragraph [0103]: “Batch mode 1800 involves the loading of the APAS cell with a batch of input drugs and diluents and syringes and IV bags for the output doses to produce a pre-defined set of drug orders.”); (See also Paragraph [0316]: “In some examples, one drug may be associated with multiple reconstitution profiles. A particular profile may be selected from the multiple profiles based on the requested drug order dosage. For example, Cefazolin 10 Gram bulk vial (e.g., Pharmaceutical Partners of Canada Inc., DIN 02237140) may be associated with two drug profiles for injection. A first profile to produce 200 MG/ML doses may include diluting with 45 ml of sterile water. A second profile to produce 100 MG/ML doses may include diluting with 96 ml of sterile water”).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to operate Osborne’s system so as to have a plurality of products concurrently in process within the clean-room region, in particular a plurality of different products as taught by Reinhardt, in order to increase throughput and enable batch, on-demand, or intermixed production of pharmaceutical products or doses. Such modification would have amounted to applying a known batch/multi-product production technique to the known automated pharmaceutical workstation of Osborne to yield predictable results, with a reasonable expectation of success because Osborne/s dual-robot architecture already supports concurrent operation with the controlled environment and Reinhardt demonstrates production of multiple and differing outputs from a single automated compounding cell. See KSR; MPEP § 2143(I)(C),(D).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Osborne (WO 2009147252 A1) in view Reinhardt et al. (EP 2457550 A1), and further in view of Winzinger et al. (EP 3815877 A1), hereinafter “Winzinger.”
Regarding Claim 6, Osborne in view of Reinhardt discloses:
The method according to Claim 1, as well as the cleaning of all surfaces and contents after working sessions, implemented by the robots (See Page 6, Line 16: “Inside the storage and preparation areas, a cleaning system is used, after one or more working sessions, to clean all the surfaces and all the contents. Such a system can, for example, be implemented by the robots. It is designed in such a way as to recover the cleaning and soiled products”).
However, Osborne/Reinhardt does not appear to explicitly disclose wherein one or more vessels, receptacles and/or tools which have been used to produce the product remain at least partially within the clean-room region after completion of the product, are cleaned and sterilized, and are subsequently reused for producing a further product.
Reasonably pertinent to the problem of maintaining sterile conditions while keeping handling components available without repeated transfer through locks, Winzinger teaches:
wherein one or more vessels, receptacles and/or tools which have been used to produce the product remain at least partially within the clean-room region after completion of the product, are cleaned and sterilized, and are subsequently reused for producing a further product (See Paragraph [0027]: “Preferably, the cleanroom is subjected to automatic cleaning and/or sterilization, for example at regular intervals, whereby the unassembled, i.e. unused, component is placed by the robot arm in such a storage location in the cleanroom that it is included in the sterilization and/or cleaning process of the cleanroom, i.e. synergistically cleaned or sterilized”); (See also Paragraph [0033]: “In particular, the components to be replaced do not need to be laboriously brought into and removed from the cleanroom through airlocks or similar means. Rather, the unused parts can remain in the cleanroom, so that they are immediately available for another format change”). (See also Paragraphs [0047-0048]: “The components can be placed in the magazine in a suitable orientation so that cleaning or sterilization medium can reach these surfaces. Accordingly, it may be possible that a specific component is cleaned and/or sterilized alternately in the magazine and in the installation position in the carousel at a station over certain periods of time.”
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Osborne’s system so that vessels, receptacles, tools, and/or components used to produce the product remain at least partially within the clean-room region after completion of the product, are cleaned and sterilized, and are reused for producing a further product, as taught by Winzinger, in order to reduce repeated transfer of components through locks, maintain sterile conditions, and keep components available for subsequent production. Such modifications would have amounted to applying a known clean-room retention-and-sterilization technique to the known automated clean/sterile pharmaceutical production workstation of Osborne to yield predictable results, with a reasonable expectation of success given that Osborne already performs robot-implemented cleaning of all surfaces and contents within its isolated clean-room chamber. See KSR; MPEP § 2143(I)(C),(D).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. US 20160076780 A1, Process For Operating A Clean Room And Control Device, relates to a process for operating a clean room and to a control device for a clean room, the clean room comprising a work room, a room ventilation system and a control device. US 10071177 B1, Hospital And Operating Room Designs And Sterilization Methods, is in the field of improved hospital and operating room designs and sterilization methods.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Fathi Abdelsalam whose telephone number is (571) 270-0380. The examiner can normally be reached Monday through Friday from 10 AM to 6 PM ET.
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/ERNESTO A SUAREZ/Supervisory Patent Examiner, Art Unit 3655
/FATHI K. ABDELSALAM/Examiner, Art Unit 3655
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