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 .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/08/2025 has been entered.
Amendments of Claims 1 to 7, 10 and 11are acknowledged.
New Claims 13 to 18 are acknowledged.
It is to be noted that:
If a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will perform the claimed process. Thus, the method, as claimed, would necessarily result from the normal operation of the apparatus. See MPEP 2112.02.
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 11, 13 and 17 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.
Regarding Claims 11 and 17:
The Claim include the limitation “so that the path along which a movement of the manipulator is performed can be logged in the memory unit”. It is unclear if the path is actually being logged in the memory unit or not. For prosecution it is being considered as the path is being logged in the memory unit. The same argument and consideration is made for claim 17.
Regarding Claim 13:
The claim includes the limitation: “at least one of the following is logged: over what period of time the manipulator was moved in the primary air supply or with what coverage the manipulator was moved in the primary air supply”. But it is unclear where the logging is done. For prosecution it will be considered that the logging is at a memory unit of a computing unit same as on claim 11.
Claim Rejections - 35 USC § 102
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 7 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Procyshyn (US 20140196411).
Regarding Claim 7:
Procyshyn discloses a device for handling of disturbances in a filling and/or closing and/or post-processing installation for the pharmaceutical industry comprising a manipulator and a computing unit configured to plan a path along which the manipulator is movable to handle the disturbance (Figure 2, filling system 10, Robotic arms 30, 40, 50 will be considered the manipulator, Figure 1, paragraph 0027, the optical sensor 12 is configured to perform a pre-fill inspection of containers 90 to determine if any containers are defective or otherwise unfit for filling, If a defective container is found it can be considered a “disturbance” as defined, an irregularity in the process flow, the container will be ignored during the filling process and it will be considered the “handling of the disturbance”; Paragraph 0033, once the containers 90 have been filled, the holding arm 30 can be used to open a port 22, to place the tray 80 of filled containers 90 within a transfer isolator for removal of the filled containers 90 from within the chamber 20),
and a computing unit configured to plan a path along which the manipulator is movable to handle the disturbance (Paragraph 0027, 0031, 0034, the arms are controlled by a not numbered controller of the filling system 10), wherein the path is planned in such a way that travel paths of the manipulator which influence a primary air supply to primary packaging means and/or to components of the filling and/or closing and/or post-processing installation which are in contact with the primary packaging means are minimized (Paragraph 0048, the systems are configured to be minimally disruptive to sterilized air flows commonly used in aseptic filling, that will be considered the claimed “primary air supply”, also Paragraph 0045 mentions how the turntable is moved to minimize movement of the robotic arms).
Regarding Claim 8:
Procyshyn discloses that the computing unit is configured to plan the path using an algorithm optimized for pharmaceutical compliance, wherein criteria for pharmaceutical compliance are in particular selected from a group comprising:
minimization of a time for which the manipulator is arranged above the primary packaging means,
minimization of a time for which the manipulator is arranged above components of the filling and/or closing and/or post-processing installation which are in contact with the primary packaging means,
flow optimization of a movement and/or speed profile,
minimization of a rotation of axes of the manipulator,
minimization of a movement of a handling system of the manipulator above the primary packaging means and/or the components of the filling and/or closing and/or post-processing installation which are in contact with primary packaging means,
minimization of a gripper movement above the primary packaging means, and
minimization of an impact surface in the primary air supply.
(Paragraphs 0023 and 0034, filling system 10 handles pharmaceutical products, so it will be considered that the not numbered controller of the filling system 10 is running a software optimized for pharmaceutical compliance, such software will be considered an algorithm; wherein the criteria for pharmaceutical compliance, as indicated on Paragraph 0048, the systems are configured to be minimally disruptive to sterilized air flows commonly used in aseptic filling, that lacking any additional limitations will be considered as “minimization of an impact surface in the primary air supply”, also Paragraph 0045 mentions how the turntable is rotated to minimize movement of the robotic arms, that can be considered “minimization of a movement of a handling system of the manipulator above the primary packaging means and/or the components of the filling and/or closing and/or post-processing installation which are in contact with primary packaging means”).
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 9 is rejected under 35 U.S.C. 103 as being unpatentable over Procyshyn (US 20140196411) in view of Da Silva (US 2021/0048421).
Regarding Claim 9:
Procyshyn discloses that the computing unit is configured to plan the path using an algorithm optimized for pharmaceutical compliance, wherein criteria for pharmaceutical compliance are in particular selected from a group comprising
minimization of a time for which the manipulator is arranged above the primary packaging means,
minimization of a time for which the manipulator is arranged above components of the filling and/or closing and/or post-processing installation which are in contact with the primary packaging means,
flow optimization of a movement and/or speed profile,
minimization of a rotation of axes of the manipulator,
minimization of a movement of a handling system of the manipulator above the primary packaging means and/or the components of the filling and/or closing and/or post-processing installation which are in contact with primary packaging means,
minimization of a gripper movement above the primary packaging means, and
minimization of an impact surface in the primary air supply.
(Paragraphs 0023 and 0034, filling system 10 handles pharmaceutical products, so it will be considered that the not numbered controller of the filling system 10 is running a software optimized for pharmaceutical compliance, such software will be considered an algorithm; wherein the criteria for pharmaceutical compliance, as indicated on Paragraph 0048, the systems are configured to be minimally disruptive to sterilized air flows commonly used in aseptic filling, that lacking any additional limitations will be considered as “minimization of an impact surface in the primary air supply”, also Paragraph 0045 mentions how the turntable is rotated to minimize movement of the robotic arms, that also, lacking any additional limitation, can be considered “minimization of a movement of a handling system of the manipulator above the primary packaging means and/or the components of the filling and/or closing and/or post-processing installation which are in contact with primary packaging means”).
Procyshyn (Paragraph 0034) discloses that the path is determined using an optical sensor and pattern recognition software, but does not disclose that the computing unit plan the path using an artificial intelligence model.
DaSilva (Paragraph 0048) teaches using artificial intelligence as part of a pattern recognition software from images obtained from an optical to detect defects on pieces and by identifying the depth in the images and obtaining the classification of common types of malfunctions in samples. Once each grain is classified with the proper characteristics, the system identifies its location on the table in coordinate (X, Y) form. This coordinate is sent to the robotic system.
Therefore, it would have been obvious to a person having ordinary skill in the art to which the claimed invention pertains, before the effective filing date of the claimed invention, to incorporate to Procyshyn the teachings of DaSilva and use artificial intelligence as part of a pattern recognition software to obtain and classify the defects on the filling and/or closing and/or post-processing installation and provide location information to the manipulator as an alternative way to process the information from the optical sensor.
Claims 1, 2, 4 to 6, 10 to 12, 14 to 16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Procyshyn (US 20140196411) in view of Limone (US 2020/0001457).
Regarding Claims 1 and 12:
Procyshyn discloses a method for handling of disturbances in at least one of a filling closing and post-processing installation for the pharmaceutical industry using a manipulator (Figure 2, filling system 10 will be considered the installation, Robotic arms 30, 40, 50 will be considered the manipulator, Figure 1, paragraph 0027, the optical sensor 12 is configured to perform a pre-fill inspection of containers 90 to determine if any containers are defective or otherwise unfit for filling, the information is provided to a numbered controller of the filling system 10, that will be considered a computing unit running a software program to carry out the method, If a defective container is found, the container can be ignored during the filling process; If a defective container is found it can be considered a “disturbance” as defined, an irregularity in the process flow, the container will be ignored during the filling process and it will be considered the “handling of the disturbance”, Paragraph 0033, once the containers 90 have been filled, the holding arm 30 can be used to open a port 22, to place the tray 80 of filled containers 90 within a transfer isolator for removal of the filled containers 90 from within the chamber 20), comprising the step of:
moving a manipulator along a path for handling of the disturbances, wherein the path along which the manipulator is moved is planned in such a way that travel paths of the manipulator which influence a primary air supply to at least one of a primary packaging means and to components of at least one of the filling, closing and post-processing installation which are in contact with the primary packaging means are minimized (Paragraphs 0023 and 0034, filling system 10 fills, closes and delivers pharmaceutical packages and as indicated on Paragraph 0048, the systems are configured to be minimally disruptive to sterilized air flows commonly used in aseptic filling, that lacking any additional limitations will be considered as “minimization of an impact surface in the primary air supply”).
Procyshyn does not specifically mention the manipulator is moved for collision-free handling of the disturbance.
Limone teaches a robotic system and method, which may include one or more robots using a collision avoidance algorithm to avoid collisions with the environment or between manipulators (Paragraphs 0048, 0050 and 0070) by determination of collision free paths and coordination of robots.
Therefore, it would have been obvious to a person having ordinary skill in the art to which the claimed invention pertains, before the effective filing date of the claimed invention, to incorporate to Procyshyn the teachings of Limone and use a collision avoidance algorithm to avoid collisions with the environment or between manipulators.
Regarding Claim 2:
Procyshyn discloses that the computing unit is configured to plan the path using an algorithm optimized for pharmaceutical compliance (Paragraphs 0023 and 0034, filling system 10 handles pharmaceutical products, so it will be considered that the not numbered controller of the filling system 10 is running a software optimized for pharmaceutical compliance, such software will be considered an algorithm), wherein criteria for pharmaceutical compliance are in particular selected from a group comprising:
minimization of a movement of a handling system of the manipulator above the primary packaging means and/or the components of the filling, closing and post- processing installation which are in contact with primary packaging means,
minimization of a gripper movement above the primary packaging means, and
minimization of an impact surface in the primary air supply (Paragraph 0048, the systems are configured to be minimally disruptive to sterilized air flows commonly used in aseptic filling, that will be considered as minimization of an impact surface in the primary air supply, also Paragraph 0045 mentions how the turntable is rotated to minimize movement of the robotic arms, so it will be considered as minimization of a movement of a handling system of the manipulator above the primary packaging means and/or the components of the filling, closing and post- processing installation which are in contact with primary packaging means).
Regarding Claims 4, 10, 15 and 16:
As discussed for Claims 1 and 7 above, Procyshyn, or the modified invention of Procyshyn discloses the invention as claimed.
The modified invention of Procyshyn does not disclose the path being visualized on a monitor in a digital image of the environment, wherein in particular the path is visualized before a movement of the manipulator is performed for an interactive correction and/or an approval, and/or areal movement of the manipulator is visualized on the monitor in the digital image of the environment.
Limone teaches a system and method for natural tasking one or more robots that includes creating paths for the robot tools with an offset configured so there were no collisions and at the same time avoiding tasking robots in an unnatural, over constrained way; each path is visualized on a monitor in a digital image of the environment (Figures 2, 7, 8, 9, 10 and 12 show path being visualized on a monitor before a movement of the manipulator is performed) for an interactive correction and/or an approval (Paragraph 0068, one or more constraints may be combined and/or specified by the user using a visual editor to create complex combinations of constraints that change over time to best achieve a real-world task. It should be noted that some or all of these constraints may be changed during execution of a robot task or operation, even time step by time step, and may be combined with optimizations such as collision and joint-limit avoidance. In this way, the number and type of constraints may be updated, dynamically, in real-time), a real movement of the manipulator is visualized on the monitor in the digital image of the environment (Figures 16 to 20).
Therefore, it would have been obvious to a person having ordinary skill in the art to which the claimed invention pertains, before the effective filing date of the claimed invention, to incorporate to the modified invention of Procyshyn the teachings of Limone and use a system and method for natural tasking one or more robots including the path being visualized on a monitor in a digital image of the environment, as disclosed to create paths for the robot tools with an offset configured so there were no collisions and at the same time avoiding tasking robots in an unnatural way.
Regarding Claims 5, 11, 14 and 18:
As discussed for Claims 1 and 7 above, Procyshyn, or the modified invention of Procyshyn discloses the invention as claimed, including the manipulator operation being configured to be minimally disruptive to sterilized air flows commonly used in aseptic filling.
The modified invention of Procyshyn does not disclose the path along which the manipulator is moved is electronically logged, or the computing unit being configured to at least one of identify and mark primary packaging means and components of the installation which are in contact with primary packaging means over which the manipulator is moved along the path.
Limone teaches a system and method for natural tasking one or more robots that includes creating paths for the robot tools wherein all the instructions are stored in digital media including positions of the tool of the manipulator, algorithms, velocities, constrains and images are stored for future use or for editing during operation in real time (Paragraphs 0068, data obtained from rom lidar, stereo cameras, color cameras, multispectral cameras, 0069, the user may not specify how the robotic system may perform the task and the system may determine how to perform the task automatically or using minimal inputs, 0074, graphical user interfaces 1100, 1200 configured to edit constraints and manage tool offset, 0081, Any combination of one or more computer readable medium(s) may be utilized. The computer readable medium may be a computer readable signal medium or a computer readable storage medium).
Therefore, it would have been obvious to a person having ordinary skill in the art to which the claimed invention pertains, before the effective filing date of the claimed invention, to incorporate to the modified invention of Procyshyn the teachings of Limone and store in real time the whole operation of the device, including the manipulator, that is in contact direct or indirect with the containers and closures, that in the specification are referred to as primary packaging means, when the manipulator is moved in the primary air supply or gets in contact with the primary packaging means.
Regarding Claim 6:
As discussed for Claims 1 above, the modified invention of Procyshyn disclose the invention as claimed.
The modified invention of Procyshyn does not disclose if the path is planned taking into account interference contours of an environment and/or a distance of a distal end of the manipulator is detected using virtual distance sensors, wherein the virtual distance sensors are configured to detect a distance of the distal end to the environment in a digital image of the moving manipulator and the environment.
Limone teaches a system and method for natural tasking one or more robots that includes creating paths for the robot tools with an offset configured so there were no collisions and at the same time avoiding tasking robots in an unnatural, over constrained way; the paths are planned taking into account interference contours of an environment (Paragraph 0006, The at least one natural workpiece constraint associated with the natural robot task may be selected from the group including directional constraints, assignment to a curve or surface, distance constraints, joint positions, linear and nonlinear functional combinations of joint positions, workpiece geometry, workpiece features, center of mass, and linear and angular momentum. The system may include a scanner configured to identify the at least one natural workpiece constraint associated with the natural robot task, Paragraph 0048 discuss threshold distances from other bounding volumes).
Therefore, it would have been obvious to a person having ordinary skill in the art to which the claimed invention pertains, before the effective filing date of the claimed invention, to incorporate to the modified invention of Procyshyn the teachings of Limone and use a system and method for natural tasking one or more robots including the path the paths being planned taking into account interference contours of an environment, as disclosed to create paths for the robot tools with an offset configured so there were no collisions and at the same time avoiding tasking robots in an unnatural way.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Procyshyn (US 20140196411) in view of Limone (US 2020/0001457) as applied to Claim 1 above and further in view of Da Silva (US 2021/0048421).
Regarding Claim 3:
Procyshyn discloses that the computing unit is configured to plan the path using an algorithm optimized for pharmaceutical compliance, wherein criteria for pharmaceutical compliance are in particular selected from a group comprising minimization of a movement of a handling system of the manipulator above the primary packaging means and/or the components of the at least one of the filling, closing and post- processing installation which are in contact with primary packaging means, in particular minimization of a gripper movement above the primary packaging means, and minimization of an impact surface in the primary air supply (Paragraphs 0023 and 0034, filling system 10 handles pharmaceutical products, so it will be considered that the not numbered controller of the filling system 10 is running a software optimized for pharmaceutical compliance, such software will be considered an algorithm; Paragraph 0048, the systems are configured to be minimally disruptive to sterilized air flows commonly used in aseptic filling, also Paragraph 0045 mentions how the turntable is rotated to minimize movement of the robotic arms).
Procyshyn (Paragraph 0034) discloses that the path is determined using an optical sensor and pattern recognition software, but does not disclose that the computing unit plan the path using an artificial intelligence model.
DaSilva (Paragraph 0048) teaches using artificial intelligence as part of a pattern recognition software from images obtained from an optical to detect defects on pieces and by identifying the depth in the images and obtaining the classification of common types of malfunctions in samples. Once each grain is classified with the proper characteristics, the system identifies its location on the table in coordinate (X, Y) form. This coordinate is sent to the robotic system.
Therefore, it would have been obvious to a person having ordinary skill in the art to which the claimed invention pertains, before the effective filing date of the claimed invention, to incorporate to Procyshyn the teachings of DaSilva and use artificial intelligence as part of a pattern recognition software to obtain and classify the defects on the filling and/or closing and/or post-processing installation and provide location information to the manipulator as an alternative way to process the information from the optical sensor.
Allowable Subject Matter
Claims 13 and 17 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Regarding Claim 13 and 17:
Both claims include the limitation:
wherein at least one of the following is logged: over what period of time the manipulator was moved in the primary air supply or with what coverage the manipulator was moved in the primary air supply.
As indicated in the Specification, Paragraph 0016:
In the context of the application, primary air supply means an air supply from a source or a filter, in particular a high-efficiency particulate air filter (HEPA filter for short), in a unidirectional air flow that is at least substantially particle-free.
The use of such “primary air supply” is common in the air, one of many forms is the use of what is called “laminal flow curtains” or similar to prevent contamination inside open containers or closures, in particular Procyshyn (US 20140196411), Krauss (US 2012/0090268), Bechini (EP 3335844) and Py (US 2005/0217211), just to name a few, teach avoiding or minimizing disturbing the “primary air supply” and algorithms developed to do so; but no reference on the record teach logging in the memory of a computing unit configured to plan a path along which the manipulator is movable to handle the disturbance, over what period of time the manipulator was moved in the primary air supply or with what coverage the manipulator was moved in the primary air supply or there is a reasonable motivation to modify the reference in such way.
Response to Arguments
Applicant's arguments filed 12/08/2025 have been fully considered but they are not persuasive.
Same as discussed before, the Examiner insist that Claim 1 reads:
A method for handling disturbances in an installation for the pharmaceutical industry using a manipulator, wherein the installation is at least one of a filling, closing or post-processing installation and the method comprising the step of:
moving a manipulator along a path for a collision-free handling of the disturbances, wherein the path along which the manipulator is moved is planned in such a way that travel paths of the manipulator which influence a primary air supply to at least one of a primary packaging means or to components of at least one of the fillings closing or post-processing installation which are in contact with the primary packaging means are minimized.
The Examiner notes that still the disturbance is not defined, so the examiner is free to consider having a defective container a “disturbance” even if Procyshyn doesn’t specifically calls it that way, and that container is to be avoided. Moving a manipulator along a path, on a collision free way is extremely common, in general no one wants to have a collision and regarding influencing a primary air supply, again the rule is avoiding if possible, affecting the air supply that keeps an area “clean”.
Regarding Claim 7 similar arguments can be made, still an undisclosed “disturbance” is mentioned and the manipulator is moved to avoid “influence a primary air supply”.
Claims 13 and 17 were considered could be allowable if overcome the rejections under 35 U.S.C. 112(b), set forth in this Office action and to include all of the limitations of the base claim and any intervening claims. In particular regarding Claim 13 it is required that the logging is to the memory of a computing unit configured to plan a path along which the manipulator is movable to handle the disturbance, since in general an interruption in the path of a laminar flow curtain would trigger an alarm on the installation because of physical interruption on a light sensor or a pressure sensor of the interruption is large enough, but not typically on the manipulator.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. In particular Py (US 20160068283) discloses using a robotic arm for filling containers inside an assembly device operating mounted within a barrier enclosure, with substantially sterile laminar flow barrier, Keshmiri (US 2017/0364076) that discloses modeling a route and displaying it on a monitor and Grifols (US 2004/0139698) or Bechini (EP 3335844) that disclose a method for sterile dosing of vials using a manipulator inside a laminar air-flow environment.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDUARDO R FERRERO whose telephone number is (571)272-9946. The examiner can normally be reached M-F 9:30-7:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, SHELLEY SELF can be reached at 571-272-4524. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EDUARDO R FERRERO/Examiner, Art Unit 3731
/ROBERT F LONG/Primary Examiner, Art Unit 3731