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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 October 20th, 2025 has been entered.
Response to Arguments
Applicant’s amendment, filed October 20th, 2025, has overcome the previous prior art rejections. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made below.
Applicant’s amendment has overcome all rejections under 35 U.S.C. 112. Therefore, these rejections have been withdrawn.
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(s) 1-4, 9-11, 13, and 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Veillon (WO 2017/134086) in view of Kozo et al. (JP-H0833816), previously cited.
In regards to claims 1 and 15, Veillon discloses an apparatus and method for inspecting a pharmaceutical cylindrical container made of glass or polymer (abstract, page 4, lines 25-30, and fig. 1), comprising: a support device configured to support the pharmaceutical cylindrical container (40) and rotate the container around a longitudinal axis (page 11, lines 6-8 “the mount 40 is rotationally drivable”); a light emitting unit comprising a light source (11) configured to emit unpolarized light and illuminate the container with a detection beam of (page 13, line 4 white light LED, which inherently unpolarized) while the support device rotates the pharmaceutical cylindrical container (page 13, lines 8-10 describes illuminating while rotating the bottle); a light receiving unit comprising a camera (17, page 13, line 12) that acquires polarization information of the detection beam from a surface of the cylindrical pharmaceutical container (page 13, line 26-page 15, line 10), and a control unit (50) configured to control rotation of the support device to rotate the pharmaceutical cylindrical container 360 degrees about its longitudinal axis and to adjust activation and deactivation of the light emitting unit and the camera during inspection of the pharmaceutical cylindrical container based on a speed of the rotation (page 13, lines 10-14 and page 14, lines 17-22). Veillon is silent to the light receiving unit receiving a detection beam that has been reflected on the surface of the container. However, the examiner takes official notice that it is very well known in the art of bottle inspection that an alternative to measuring light through a container, is to measure light reflected from a container, which is done in order to still receive quality information from a more opaque container, or to have less noise from receiving light from two sides of the bottle (when light is going in one side of a bottle and exiting through another side of the bottle).
For example, Kozo, in the same field of endeavor as Veillon of container inspection using a polarizing apparatus (abstract and fig. 1-2), comprises a light emitting unit comprising a light source (41) configured to illuminate the container (41 is either a mercury lamp, as disclosed on page 7, or a laser as disclosed on page 5) while a support device rotates the container (page 5 describes measuring while rotating the bottle); and a light receiving unit (53 and 54) that acquires polarization information of the detection beam reflected on a surface of the cylindrical pharmaceutical container (page 2, ⁋ 7). Therefore, it would be obvious to one of ordinary skill in the art to configure the light receiving unit of Veillon to receive receiving a detection beam that has been reflected on the surface of the container, as taught by Kozo, in order to still receive quality information from a more opaque container, or to have less noise from receiving light from two sides of the bottle.
In regards to claim 2, the light source is a source selected from a group consisting of a gas-discharge lamp, a light-emitting diode, a laser, and any combination thereof (Veillon, page 13, line 4).
In regards to claims 3-4, the apparatus further comprises polarizer, wherein the light emitting unit comprises the polarizer (as seen in fig. 1, 13). Veillon is silent to the polarizer being selected from a group consisting of a Fresnel reflection polarizer, a birefringent polarizer, a thin film polarizer, and a wire-grid polarizer. However it is disclosed that the polarizer can be any suitable conventional polarizer (page 6, lines 22-23).
Kozo, in the same field of endeavor as Veillon of bottle inspection discloses the polarizer being selected from a group consisting of a Fresnel reflection polarizer, a birefringent polarizer, a thin film polarizer, and a wire-grid polarizer (52 and abstract). Further, the examiner takes official notice that these are well-known polarizers used in the art. Therefore, it would be obvious to one of ordinary skill in the art to have the polarizer of Veillon be selected from a group consisting of a Fresnel reflection polarizer, a birefringent polarizer, a thin film polarizer, and a wire-grid polarizer, as taught by Kozo and as is well-known in the art, in order to provide the polarization of the light using a suitable conventional polarizer.
In regards to claim 9, Veillon is silent to the light receiving unit being configured to measure a first linear polarized light beam and a second linear polarized light beam, wherein the first linear polarized light beam has a first plane of polarization and the second linear polarized light beam has a second plane of polarization, wherein the first and second planes intersect at an angle in a range of 10 to 170°.
Kozo, in the same field of endeavor as Veillon of bottle inspection discloses the light receiving unit being configured to measure a first linear polarized light beam and a second linear polarized light beam, wherein the first linear polarized light beam has a first plane of polarization and the second linear polarized light beam has a second plane of polarization, wherein the first and second planes intersect at an angle in a range of 10 to 170° (abstract, S and P polarization components). This allows the different polarization components to be detected simultaneously thus allowing for quicker measurement of the surface quality. Therefore, it would be obvious to one of ordinary skill in the art to include into Veillon that the light receiving unit is configured to measure a first linear polarized light beam and a second linear polarized light beam, wherein the first linear polarized light beam has a first plane of polarization and the second linear polarized light beam has a second plane of polarization, wherein the first and second planes intersect at an angle in a range of 10 to 170°, as taught by Kozo, in order to allow allows the different polarization components to be detected simultaneously thus allowing for quicker measurement of the surface quality.
In regards to claim 10, the light receiving unit acquires information of the detection beam other than the polarization information (Veillon page 9, lines 4-9).
In regards to claim 11, the light receiving unit measures an intensity and/or a wavelength of the detection beam (Veillon page 9, lines 4-9, red, green, blue is related to wavelength, and saturation or intensity is related to intensity).
In regards to claim 13, Veillon teaches a light receiving unit that is arranged such that light transmitted through the pharmaceutical cylindrical container defines the detection beam (as can be seen in fig. 1). In combination with the teaching of claim 1, it would be obvious to one of ordinary skill in the art to include both a first light receiving unit for measuring reflected light as discussed in claim 1, and a second light receiving unit for receiving transmitted light, as taught by Veillum, in order to allow the device to get both reflective and transmissive information of the container.
In regards to claim 16, Veillum in view of Kozo discloses the method for inspecting containers, as disclosed above. Veillum further discloses discarding, based on the polarization information, any pharmaceutical cylindrical container exhibiting an unacceptable defect on an outer surface (page 8, lines 30-34). Veillum is silent to disregarding the container if exhibits a defect having a size of 40 mm or more, and/or a wall penetrating defect having a size of .5 or more. However, this is a result effective variable, that would be dependent upon the acceptable tolerances of the containers defined by the user of the method. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) MPEP 2144.05(A,II). Therefore, it would be obvious to one of ordinary skill in the art to set acceptable tolerances of unusable containers and reject the containers if exhibits a defect having a size of 40 mm or more, and/or a wall penetrating defect having a size of .5 or more, as this would require only routine optimization of the method, and in order to remove unacceptable containers that do not meet acceptable tolerances before being used for pharmaceutical applications.
Claim(s) 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Veillon (WO 2017/134086) in view of Kozo et al. (JP-H0833816), previously cited, and further in view of Paulson, Jr (5,408,321), previously cited.
In regards to claims 5-6, the combination of Veillon and Kozo discloses the apparatus for inspecting a container, as discussed above. The combination is silent to a depolarizer selected from a group consisting of a Cornu depolarizer, a Lyot depolarizer, a wedge depolarizer, and a time-variable depolarizer, wherein the depolarizer is arranged between the light source and the pharmaceutical cylindrical container.
Paulson, in the same field of endeavor of measuring polarization of a material using light (column 1, lines 5-15), discloses creating the unpolarized light using a depolarizer (fig. 3, 46) selected from a group consisting of a Cornu depolarizer, a Lyot depolarizer, a wedge depolarizer, and a time-variable depolarizer (column 6, lines 25-40), wherein the depolarizer is arranged between the light source and the material (as can be seen in fig. 3, 46 is between 42 and S). This would be done in order to allow only polarized light from the sample to reach the detector, thus leading to more accurate measurements. Therefore, it would be obvious to one of ordinary skill in the art to include into the combination a depolarizer selected from a group consisting of a Cornu depolarizer, a Lyot depolarizer, a wedge depolarizer, and a time-variable depolarizer, wherein the depolarizer is arranged between the light source and the pharmaceutical cylindrical container, as generally disclosed by Paulson, in order to allow only polarized light from the sample to reach the detector, thus leading to more accurate measurements.
Claim(s) 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Veillon (WO 2017/134086) in view of Kozo et al. (JP-H0833816), previously cited, and further in view of Meeks (US 2004/0169850).
In regards to claims 7-8, the combination is discussed above. Veillon discloses further comprises a wave plate selected from a group consisting of a half-wave plate, a quarter-wave plate, full-wave plate, and sensitive-tint plate (fig. 1, 15; page 7, line 11). Veillon is silent to the waveplate being in the light emitting unit. However, the examiner takes official notice that it is well-known to place the waveplate in the light emitting unit, in order to control the polarization of the light before it hits the sample.
For example, Meeks, in the same field of endeavor of measuring polarization of a material, discloses the waveplate being in the light emitting unit and is done to control the polarization of the light reaching the sample (fig. 1, 303 and ⁋ 69). Therefore, it would be obvious to one of ordinary skill in the art to have the waveplate of the combination be placed in the light emitting unit, as taught by Meeks, in order to control the polarization of the light before it hits the sample.
Claim(s) 14 is rejected under 35 U.S.C. 103 as being unpatentable over Veillon (WO 2017/134086) in view of Kozo et al. (JP-H0833816), previously cited, and further in view of Ringlien (US 4,610,542), previously cited.
In regards to claim 14, the combination discloses the apparatus for inspecting containers, as disclosed above. The combination is silent to the light emitting unit and/or the light receiving unit are arranged such that α = β = arctan (n), wherein α is an angle between a centerline of the light source and a normal N of a lateral surface of the pharmaceutical cylindrical container, wherein β is an angle between a centerline of the camera and the normal N of the lateral surface, and wherein n is a refractive index of the glass or polymer of the pharmaceutical cylindrical container.
However, differences in the transmittance range of the angle of the light emitting unit and/or the light receiving unit will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such range is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) MPEP 2144.05(A,II). In this case, Ringlien establishes result-effectiveness by teaching inspection of glass container by illumination and receiving images of refractive defects of said container at acceptable angles of illumination. (See Abstract, Col 5 Lines 66-Col 6 Lines 1-29, Col 8 Lines 15-36; Fig. 1). Moreover, applicant has not established a criticality to the claimed range. Therefore, it would be obvious to one of ordinary skill in the art to arrange the light emitting unit and or light receiving unit at an angle that satisfies the claim in order to allow a highly sensitive illumination system for determining the presence of sharp refractive defects while suppressing the appearance of more gradual surface discontinuities that might be present in. (See Col 8 Lines 38-49 of Ringlien).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARA E GEISEL whose telephone number is (571)272-2416. The examiner can normally be reached Monday-Friday 10am-6pm.
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/KARA E. GEISEL/
Supervisory Patent Examiner
Art Unit 2877
Prosecution Insights