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
Preliminary Amendment
The preliminary amendment filed on 02/28/2025 has been entered into this application. Claims 10, 13 and 15 are cancelled. Claims 16-23 have been added.
Information Disclosure Statement
The information disclosure statement filed on 02/28/2025 has been entered and considered by the examiner.
Drawings
The drawings filed on 02/28/2025, has been accepted for examination.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-9, 11-12, 14 and 16-23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Milne et al. (2014/0177932 A1).
Regarding claims 1, 12 and 14, Milne discloses an inspection system/method/inspection 160 (figs. 1A-2A, 4-12, 38A-38C and 45) operative to inspect a medical container (10) containing a liquid, the inspection system/method of inspecting a medical container containing a liquid is performed by an inspection system inspection 160 (figs. 1A-2A, 4-12, 38A-38C and 45) (claim 14) comprising:
a sample holder included in a spindle 150/tray172, operative to hold the medical container (10) along an axis [pars. 0119-130];
at least one optical system the unit 100 (figs. 1A and 38B) [pars. 0125-133] having:
at least one light source included in illumination system 120 operative to output light incident onto the medical container (10); and
at least one detector an imager 110 operative to detect return light from the medical container (10), wherein the at least one detector comprises a first detector included in plurality of imager(s) comprising an opto-electrical transducer having a plurality of pixels [pars. 0143-0146]; and
an evaluation system a processor 130 coupled to the at least one optical detector and operative to detect and/or determine characteristics of a particle in the medical container based at least on an output of the at least one detector [pars. 0125, 0184-0186];
at least one actuator operative to move the at least one light source and/or the at least one detector around the axis while the sample holder (10) [par. 0249] holds the medical container in a rotationally and translationally fixed manner [pars. 0278-279, 0289];
wherein the at least one light source comprises a first light source included in LED arrays operative to output a light sheet [pars. 0178], and wherein the first detector comprises a tilt objective as can be seen in depicted drawing (figs. 6 and 38).
For the purpose of clarity, the method claims 12 and 14 is/are taught/suggested by the functions shown/stated/set forth with regards to the apparatus/system claim 1 as rejected above as being anticipated by Milne.
As to claim 2, Milne also discloses wherein the at least one actuator/mechanism that actually moves or controls a mechanism is operative to move the at least one light source and the at least one detector along a path that is curved around the axis [pars. 0279, 0289], as can be seen in depicted drawing (figs. 6A and 38B, curve angle 1200);
As to claims 3-4, Milne also discloses a structure that is use in an inspection system that is implementing limitations such as, further comprising a frame included in the inspection platform 170 (fig. 1C) on which the at least one optical system the unit 100 that includes the imager 110 and the illumination system 120 is supported, wherein the sample holder that is included in the spindle 150/tray172 is arranged implicitly in a fixed location relative to the frame, and wherein the at least one actuator/mechanism that actually moves or controls a mechanism is operative to move the at least one light source and/or the at least one detector relative to the frame, as can be seen in depicted drawing (figs. 6A and 38B, curve angle 1200) (claim 3); and wherein the at least one actuator/mechanism that actually moves or controls a mechanism comprises a first actuator/mechanism that actually moves or controls a mechanism is included in the array of optical system that include array of light source operative to move the first light source around the axis as can be seen in depicted drawing (figs. 6A and 38B, curve angle 1200) [pars. 0158, 0289] (claim 4).
As to claim 5, Milne also discloses wherein the first detector included in CMOS arrays [pars. 0145, 0171] is operative to provide a first detector output responsive to the return light during illumination of the medical container with the light sheet, wherein the first detector comprises a Scheimpflug camera (i.e. wherein particle image has a significant number of pixels to the right of the threshold value) [pars. 0129, 0261-262].
For the purposes of clarity, Scheimpflug imaging refers to a technique where the lens plane is tilted relative to the particle and focal planes, in the same manner as the particle image has a significant number of pixels to the right of the threshold value (tilt and swing to the right/left). Also, the robot 180 include a six-axis robotic arm that can spin, vibrate, and/or shake (e.g., perform the "back-and-forth" needle shaking described below) the container 10 that anticipates the effect of relative Scheimpflug camera.
As to claim 6, Milne further discloses wherein the evaluation system the processor 130 is operative to at least one of: detect, based at least on the first detector output, the particle when the particle is located in the light sheet; determine, based at least on the first detector output, that the particle is located in an interior of the medical container [pars. 0145]; discriminate, based at least on the first detector output, the particle from a bubble in a liquid within the medical container [par. 0238];
discriminate, based at least on the first detector output, the particle from an impurity/contaminant within a container wall of the medical container [pars. 0176, 0197]; determine, based at least on the first detector output for several different angular positions of the first light source and/or the first detector around the axis, information on a morphology of the particle, a three-dimensional surface shape of the particle [par. 0178]; determine, based at least on the first detector output, information on a size of the particle, a three-dimensional size of the particle [pars. 0166, 0197, 0283-286].
As to claims 7, 8, and 9, Milne also discloses a structure that is use in an inspection system that is implementing limitations such as, wherein a non-destructive analytical technique that maps the chemical composition and molecular structure of the particle(s) by shining a focused laser/the fiber/probe beam onto the particles in the container sample and measuring the scattered light to create a detailed visual characteristic/map of its chemical makeup/properties [pars. 0178, 0180, 0274] (fig. 8) is wherein the at least one light source comprises a second light source included in LED array/ light sources 122 operative to output a Raman probe beam (focus fiber light beam) and the at least one detector comprises a second detector (i.e. a second camera (1102b) [par. 0173]/ coupled to a Raman spectrometer (claim 7); wherein the at least one light source that is included in the LED arrays comprises a second light source that is included in the LED arrays operative to output a Raman probe beam (focus fiber beam) and the at least one detector included in detector array comprises a second detector included in detector array (fig. 38) coupled to a Raman spectrometer [par. 0118] (fig. 45) (Milne, claims 124, 131), wherein the at least one actuator/mechanism that actually moves or controls a mechanism comprises a second actuator operative to move both the second light source (figs. 6, 8 and 38) and the second detector, wherein the second actuator has more degrees of freedom than the first actuator [par. 0249] (figs. 6, 8 and 38), and/or the inspection system/inspection 160 (figs. 1A-2A, 4-12, 38A-38C and 45) implicitly comprises a control device operative to control the second actuator/mechanism that actually moves or controls a mechanism based at least on the first detector that is included in detector array output (claim 8); and wherein the evaluation system processor 130 is operative to determine chemical characteristics of the particle based at least on a second detector that is included in detector array output provided by the second detector or a Raman spectrum provided by the Raman spectrometer [par. 0118] (fig. 45) (Milne, claims 124, 131) (claim 9).
For the purposes of clarity, Raman probe beam imaging is considered as a non-destructive analytical technique that maps the chemical composition and molecular structure of a material/sample by shining a focused laser/light/probe beam onto a sample and measuring the scattered light to create a detailed visual fingerprint map of its chemical makeup.
As to claims 11, Milne also discloses a structure that is use in an inspection system that is implementing limitations such as, a filling device (i.e. a syringe 12) operative to fill at least one liquid into a medical container [pars. 0141, 0245-248];
a closure device cap operative to close the medical container with the at least one liquid contained therein as can be seen in depicted drawing (fig. 3A); and an inspection system /inspection 160 (figs. 1A-2A, 4-12, 38A-38C and 45) according to claim 1 operative to inspect the closed medical container for particulate matter [pars. 0002, 0101-102, 0119, 0130].
As to claims 16-17, Milne also discloses a structure that is use in an inspection system that is implementing limitations such as, wherein at least a segment of the path extends in a plane perpendicular to the axis (claim 17); and wherein the path comprises an elliptical arc and/or a circular arc (claim 18), as can be seen in depicted drawing (figs. 6, 8 and 38).
As to claims 18-20, Milne also discloses a structure that is use in an inspection system that is implementing limitations such as, wherein the at least one actuator/mechanism that actually moves or controls a mechanism is operative to concurrently change a position and an orientation of the at least one light source included in LED arrays relative to keep the illumination light incident onto the medical container (10) and/or the axis (claim 18); wherein the at least one actuator/mechanism that actually moves or controls a mechanism is operative to concurrently change a position and an orientation of the at least one detector that is included in detector array to cause the return light to be incident onto the at least one detector (claim 19); and wherein the first actuator/mechanism that actually moves or controls a mechanism is operative to relatively move the first light source around the axis such that the light sheet remains incident upon the axis as the first light source is moved around the axis (claim 20), as can be seen in depicted drawing (figs. 6 and 38) [pars. 0278-279, 0289] [par. 0249].
As to claim 21, Milne also discloses wherein the evaluation system processor 130 is operative to determine chemical characteristics detect a characteristic (e.g., a spectral characteristic) of one or more particles in the container 10 [pars. 0003, 0298) of the particle based at least on a second detector output provided by the second detector or a Raman spectrum provided by the Raman spectrometer (Spectral Detection) [par. 0118] (fig. 45) (Milne, claims 124, 131) [pars. 0178, 0180, 0274] (fig. 8).
As to claims 22-23, Milne also discloses a structure that is use in an inspection system that is implementing limitations such as, wherein robot 180 may include a six-axis robotic arm that can spin, vibrate, and/or shake (e.g., perform the "back-and-forth" needle shaking described below) the container 10, which also obviates the need for spindles 160 [par. 0129] that provide relative effect of the first actuator has one degree of freedom and the second actuator has at least two degrees of freedom (claim 22); and wherein the second actuator included in the second detection device assembly comprises a multi-axis robotic arm or a multi-axis linear displacement actuator (claim 23), as can be seen in depicted drawing (figs. 1A-2A, 4-12, 38A-38C and 45) [pars. 0278-279, 0289].
Additional Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The references listed in the attached form PTO-892 teach of other prior art inspection system/method.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Isiaka Akanbi whose telephone number is (571) 272-8658. The examiner can normally be reached on 8:00 a.m. - 4:30 p.m.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tarifur R. Chowdhury can be reached on (571) 272-2287. The fax phone number for the organization where this application or proceeding is assigned is 703-872-9306.
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/ISIAKA O AKANBI/Primary Examiner, Art Unit 2877
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