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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-2, 4, 6, 8, and 12-13 in the reply filed on 8/11/2026 is acknowledged. Claims 51 and 55-66 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Knollenberg (US 20210140867 A1) in view of Zhang (CN 104111144 A).
Regarding claim 1, Knollenberg teaches A particle counting device for counting particles in a sterilisation tunnel of a medicament filling system (NOTE: the sterilization tunnel is not positively recited and so long as the prior art can be placed in a sterilization tunnel, it would read on this limitation), wherein the sterilisation tunnel comprises at least one conveyor belt (NOTE: the sterilization tunnel and its conveyor are not positively recited), wherein the particle counting device comprises:
-at least one probe (Fig. 4: sample probe 30) that can be connected to a particle counter for receiving particles in the sterilisation tunnel (par. 48: The sample probe 30 has a sampling port 40 that is fluidically connected via a flow path 50 (e.g., tube or conduit) to the particle analyzer inlet 20; par. 53: with flow path 50 providing surface 5 dislodged particles to particle counter 10);
- at least one scanner, wherein the scanner comprises:
- at least one transverse runner with at least one linear guide (Fig. 4: vertical lines attached to sample probe 30),
- at least one bogie, wherein the transverse runner is mounted on the bogie (Fig. 4: upper and lower horizontal lines that form 400),
and
- at least one controller, wherein the controller is configured to control a movement of the scanner (par. 53: FIG. 4 illustrates a sample probe 30 with ejection system connected to a machine controller 400, illustrated as an x-y translation stage controlled by stepper motors. In this manner, coverage of a surface area of surface 5 can be automatically and reliably controlledNOTE: the machine would necessarily have a controller in order to automate movement) but does not teach
with at least one probe holder for mounting the probe
wherein the linear guide is configured to guide the probe holder transversely to a transport direction of the conveyor belt of the sterilisation tunnel;
wherein the bogie is configured to move the linear guide in the transport direction of the conveyor belt.
However, Fig. 4 in conjunction with the recited functionality of being able to move the probe along an x-y translation stage already makes it obvious to one of ordinary skill in the art that the probe is moving in the x-y direction (mapping to the transport/transverse direction) via the stepper motors, along the vertical and horizontal linear guides that make up machine controller 400.
Zhang teaches a device for moving a probe and a particle counter (abstract: A high-efficiency air filter scanning leak detecting device; par. 8: a second servo motor respectively drive the sample probe movement along the X and Y direction; par. 5: an upstream laser dust particle counter, a downstream laser dust particle counter). Zhang teaches an analogous translation movement device that more explicitly reads on the structural and functional features recited in the instant claim and would fulfill the exact X-Y translation function taught by Knollenberg.
Zhang teaches a probe holder for mounting the probe (Fig. 4-5: slide block 16107),
a transverse runner with at least one linear guide wherein the linear guide is configured to guide the probe holder in a transverse direction (Fig. 4-5: X direction guide rail 16108),
a bogie, wherein the transverse runner is mounted on the bogie, wherein the bogie is configured to move the linear guide in a transport direction (Fig. 5: first guide rail 16104 and second guide rail 16105; par. 41: the first servo motor 16101 and the second servo motor 16102 respectively drive the sampling probe along the X and Y direction, the X direction guide rail 16108 the Y direction, a first guide rail 16104 and Y are installed for limiting switching downstream sampling probe 16110 travel range to the second guide rail 16105 of the two ends).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Knollenberg to have at least one probe holder for mounting the probe attached the its transverse runner
wherein the linear guide is configured to guide the probe holder transversely to a transport direction;
wherein the bogie is configured to move the linear guide in the transport direction, as taught by Zhang, as a known means of moving a probe connected to a particle counter in both horizontal and vertical translational directions.
Regarding claim 4, Knollenberg modified by Zhang teaches the particle counting device according to claim 1, as set forth above, and teaches wherein the particle counting device further comprises at least one particle counter that can be connected to the probe (par. 48: The sample probe 30 has a sampling port 40 that is fluidically connected via a flow path 50 (e.g., tube or conduit) to the particle analyzer inlet 20; par. 53: with flow path 50 providing surface 5 dislodged particles to particle counter 10).
Claims 2, 6, 8, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Knollenberg modified by Zhang in view of Hollman (US 7180317 B2).
Regarding claim 2, Knollenberg modified by Zhang teaches the particle counting device according to claim 1, as set forth above, but does not teach wherein the controller comprises a programmable logic controller.
Knollenberg already teaches wherein the movement of the probe can be manual (par. 11: where a user can readily move the probe to the desired surface) which provides motivation to allow a user to customize the machine controlled movement of the probe as well.
Hollman teaches an automated system for moving a probe (abstract: A method and system for probing… A housing is provided with a carrier therein for supporting the specimen in relation to the microscope and a probe assembly is positionable on the surface of the specimen for conveying and acquiring electrical test signals to and from the specimen A drive system is provided for shifting at least one of the probe and the carrier to a predetermined test position). Hollman teaches wherein the system controller can be programmed (C6L23-32: A Model 900VM manipulator, manufactured by The Micromanipulator Company, Inc., Carson City, Nev., is designed to meet the needs of "hands-off" operation and programmable probe applications. The manipulators 18 23 are motorized in the X, Y and Z axes. The Z axis positioning is aided by manual, coarse positioning allowing compensation for various probe holders and probe station systems, which may be operated in a fully programmable or motorized-only (e.g., joystick control) mode depending upon the choice of control system).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the machine controller of Knollenberg modified by Zhang to be programmable, as taught by Hollman, in order to allow the user to customize the movement of the probe without manual operation, which increases convenience.
Regarding claim 6, Knollenberg modified by Zhang teaches the particle counting device according to claim 1, as set forth above, but does not teach further comprising at least one stationary user interface, wherein the user interface is connected to
the scanner and wherein a movement of the scanner is controllable by means of the user interface.
Knollenberg already teaches wherein the movement of the probe can be manual (par. 11: where a user can readily move the probe to the desired surface) which provides motivation to allow a user to customize the machine controlled movement of the probe as well, without having to manually move the probe.
Hollman teaches a stationary user interface connected to the scanner wherein the user interface controls the movement of the scanner (abstract: A drive system is provided for shifting at least one of the probe and the carrier to a predetermined test position; C2L26-42: The computer includes a display which shows a viewer an enlarged view of the surface of the specimen being probed. A cursor indicates the selected location or test site on the specimen at which test signals are transferred to and from the probe. In this manner, an operator can change selected test locations via on-screen manipulation of the cursor, as by a mouse or other computer interface control. Moving the cursor causes the relative position between the probe and the specimen surface to shift under software control so that the probe is oriented at the selected test site. To this end, the software is programed to operate actuators of the probe assemblies and/or the carrier on which the specimen is affixed for precision shifting thereof to position the probe at the selected test site. Accordingly, with a mouse, an operator can click on the cursor, and drag it across the screen to the desired conductive path indicia location or terminal they desire to test; C6L41-43: The model 900VM may be used with joystick only control (REM version) or with external computer control; NOTE: external control is interpreted to teach that the computer can be stationary). The controller calculates a particular path for shifting the probe (C49L44-54: To this end, the software is programed to operate actuators of the probe assemblies 106 and/or the carrier 250, (e.g., X, Y and Z stages 312 316 and/or the motion control mechanisms 450), on which the specimen is affixed for precision shifting thereof to position the probe 256 at the selected test site. More particularly, the software is used to interpret the cursor movement and determine the precise distance with which the DUT needs to be moved. This analysis may not only require the application of a scaling factor to calculate the horizontal distance that must be traveled). Furthermore, the probe is specifically positioned to perform analysis at the position (abstract: a probe assembly is positionable on the surface of the specimen for conveying and acquiring electrical test signals to and from the specimen), which, for Knollenberg, would mean that its probe is positioned to convey particles to the particle counter for analysis. Furthermore, the position of the probe is displayed on an interface (C49L21-24: The control panel 584 also displays the current position data below the XY settings 590 and Z settings 592, and allows the probe station user to select what units measurements and/or movements are made in), which is advantageous for further positioning of the probe and also marking a location from which the data is drawn.
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the machine controller of Knollenberg modified by Zhang to have a user interface that allows the user to move and position the probe to a desired location, whereby the probe conducts analysis (which means working with the particle counter to count the particles), and wherein the interface displays the current position of the probe and calculates a path for the movement of the probe, as taught by Hollman, in order to allow a user to conveniently perform particle counts at desired locations while also keeping track of the exact locations the particle counts were taken from, with much less manual labor.
Regarding claim 8, Knollenberg modified by Zhang and Hollman teaches the particle counting device according to claim 6, as set forth above, but does not teach wherein at least one travel path and/or measuring positions for particle counting are predeterminable by means of the user interface.
Hollman teaches wherein the system controller can be programmed for automatic movement of the probe as opposed to a user actively controlling its movement (C6L23-32: A Model 900VM manipulator, manufactured by The Micromanipulator Company, Inc., Carson City, Nev., is designed to meet the needs of "hands-off" operation and programmable probe applications. The manipulators 18 23 are motorized in the X, Y and Z axes. The Z axis positioning is aided by manual, coarse positioning allowing compensation for various probe holders and probe station systems, which may be operated in a fully programmable or motorized-only (e.g., joystick control) mode depending upon the choice of control system).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the machine controller of Knollenberg modified by Zhang to be programmed to automate movement, as taught by Hollman, in order to allow the user to customize the movement of the probe without manual operation, which increases convenience. A preprogrammed movement would read on a predetermined travel path and/or predetermined measuring positions.
Regarding claim 12, Knollenberg modified by Zhang and Hollman teaches the particle counting device according to claim 6, as set forth above, and teaches wherein the user interface is further configured to specifically move the probe to at least one predeterminable probe position and to carry out a particle count there (see Hollman modification in claim 6 rejection wherein the user selects the next location and the probe is configured to carry out its analysis at that location, wherein analysis for Knollenberg means performing a particle count).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Knollenberg modified by Zhang and Hollman in view of Lutz (US 20210140867 A1).
Regarding claim 12, Knollenberg modified by Zhang and Hollman teaches the particle counting device according to claim 6, as set forth above, but does not teach wherein the user interface is configured to record and in particular to display particle counts as a function of a probe position, wherein the user interface is, in particular, additionally connected to a particle counter.
Knollenberg was modified by Hollman in the rejection to claim 6 to have its user interface display the position of the probe. Thus, if the particle count at that position is also displayed, it would be displayed as a function of the position.
Lutz teaches a moving particle counter that counts particles at different positions (abstract: A surface particle detector that includes a scanner slidable over a surface, a particle counter for counting particles passed therethrough, and a conduit connected between the scanner and the particle counter). Lutz teaches a display connected to the particle counter for showing the current particle count, wherein the display also shows the position (par. 36: The particle counter assembly 12 includes a front display panel 86… Collect Data: shows current or last particle count data (FIG. 8B); Fig. 8A-8F). This is advantageous for making it more convenient for the user to view the data analysis, as Knollenberg itself does not teach a way for users to access the data they wanted to acquire in the first place. Particle count data is also recorded (par. 36: View Data: shows previously recorded data).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Knollenberg modified by Zhang and Hollman to have a user interface connected to the particle counter for recording and displaying both the particle count at a position and the position the data was recorded at (this interface along with the interface added by the Hollman modification would still constitute a single user interface), as taught by Lutz, in order to conveniently allow the user to view the data analysis.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHANGRU CHEN whose telephone number is (571)272-1201. The examiner can normally be reached Monday-Friday 7:30-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached on (571) 272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.C./Examiner, Art Unit 1796
/KEVIN JOYNER/Primary Examiner, Art Unit 1799
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