Prosecution Insights
Last updated: August 16, 2026
Application No. 18/835,139

Visual Inspection Systems for Containers of Liquid Pharmaceutical Products

Non-Final OA §102§103
Filed
Aug 01, 2024
Priority
Feb 08, 2022 — provisional 63/307,931 +3 more
Examiner
PEREZ-GUZMAN, CARLOS GABRIEL
Art Unit
2877
Tech Center
2800 — Semiconductors & Electrical Systems
Assignee
Amgen Inc.
OA Round
1 (Non-Final)
82%
Grant Probability
Favorable
1-2
OA Rounds
3m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 82% — above average
82%
Career Allowance Rate
122 granted / 149 resolved
+13.9% vs TC avg
Strong +24% interview lift
Without
With
+24.3%
Interview Lift
resolved cases with interview
Typical timeline
2y 3m
Avg Prosecution
23 currently pending
Career history
167
Total Applications
across all art units

Statute-Specific Performance

§101
4.2%
-35.8% vs TC avg
§103
53.9%
+13.9% vs TC avg
§102
19.9%
-20.1% vs TC avg
§112
17.7%
-22.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 149 resolved cases

Office Action

§102 §103
DETAILED ACTION 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 13-15, 17-21, 25-26, 28-29 in the reply filed on 4/13/2026 is acknowledged. Claim Objections Claims 26 and 28 are objected to because of the following informalities: In claims 26 and 28 , lines 1-2 “by one or more processors” should be changed to —by the one or more processors—. Appropriate correction is required. 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 13-14 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Milne et al. (WO 2020247357 A1), hereafter Milne. Regarding Claim 13, Milne teaches an automated visual inspection system (Fig. 6, element 604, [0049-0050]), comprising: a profile view imager (Fig. 3 element 302a) having an optical axis that enters a container through a side wall of the container, [0031-0032] the container being at least partially translucent, (“a portion of the vessel being transparent or translucent to allow light to pass through the vessel walls and into the sample within the vessel”, [0031]), a ring light that is coaxially aligned with a central axis of the container, below the container, and oriented to emit light toward a bottom of the container, (“the visual inspection system 300 may include ring LED lights both above and below the sample (e.g., continuous LED ring lights that each have a ring diameter substantially greater than the diameter of the vessel, [0038]); and a holding means (Fig. 3 element 306) for supporting and/or securing the container, [0032]. Regarding claim 14, Milne teaches the system as in claim 13, further comprising: at least one of: (a) a container rotator (Fig. 3 element 306), [0032, 0049]), (b) one or more additional profile view imagers (Fig. 3 element 302b) oriented parallel with a respective optical axis to view at least a portion of a respective profile of the container, [0034] or (c) a bottom imager coaxially aligned with the central axis and oriented to view the bottom of the container. Regarding claim 18, Milne teaches the system as in claim 13, further comprising: a container rotator, (Fig. 3 element 306), [0032, 0049]). 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 15 is rejected under 35 U.S.C. 103 as being unpatentable over Milne et al. (WO 2020247357 A1), hereafter Milne. Regarding claim 15, Milne teaches the system as in claim 14, comprising the (b) one or more additional profile view imagers (Fig. 3 element 302b). Even though Milne teaches wherein the one or more additional profile view imagers consist of three profile view imagers, (Fig. 3 elements 302b, 302c and 302d, [0031, 0033]; Milne does not clearly teach wherein the one or more additional profile view imagers consist of four profile view imagers, However, Milne discloses the visual inspection system 300 may include additional components and may include one or more additional cameras at one or more angles of inclination/declination, and/or at different positions around the perimeter of the vessel, [0038] Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to duplicate one of the three additional profile view imager as the duplication “the additional profile view imagers consist of four profile view imagers “ as is a matter of obviousness since it at most replicates the profile view imagers taught by Milne et al. without altering the design, function, and/or mode of operation of the general teaching concept of Milne et al., for the purpose of obtaining one or more angles of inclination/declination, and/or at different positions around the perimeter of the vessel , ([0038], Milne), in order to increasing the spatial resolution of the device ([0075], Milne) and also since it has been held that mere duplication of parts/process has no patentable significance unless a new and unexpected result is produced. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). MPEP 2144.04. Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Milne et al. (WO 2020247357 A1), hereafter Milne in view of Furnas et al. (US 2004/0263618 A1, included in IDS on 08/01/2024), hereafter Furnas. Regarding claim 17, Milne teaches the system as in claim 13. Milne fail to teach a proximal polarizing film axially aligned with the optical axis, positioned at a second distance from the profile view imager, and oriented perpendicular to the optical axis, the second distance being less than a first distance between the container and the profile view imager; a liquid crystal device axially aligned with the optical axis, positioned at a third distance from the profile view imager, and oriented parallel to the proximal polarizing film, the third distance being greater than the second distance and less than the first distance; a distal polarizing film axially aligned with the optical axis, positioned at a fourth distance from the profile view imager, and oriented parallel to the proximal polarizing film and the liquid crystal device, the fourth distance being greater than the first distance; and a light source oriented to emit illumination toward the distal polarizing film. However, Furnas related to vessel inspection devices and thus from the same field of endeavor teaches: a proximal polarizing film (Fig. 1 element 24) axially aligned with the optical axis, positioned at a second distance from the profile view imager (Fig. 1 element 26), [0007], and oriented perpendicular to the optical axis, [0007], (as shown in Fig. 1), the second distance (annotated Fig. 1 below element X2) being less than a first distance (annotated Fig. 1 below element X1) between the container (Fig. 1 element 10) and the profile view imager (26), (as shown in annotated Fig. 1, below X2 < X1). a liquid crystal device (Fig. 1 elements 18 + 20 + 22) axially aligned with the optical axis, (as shown in Fig. 1), positioned at a third distance (annotated Fig. 1 below element X3) from the profile view imager (26), and oriented parallel to the proximal polarizing film (24), [0007], (as shown in Fig. 1), the third distance (x3) being greater than the second distance (x2) and less than the first distance (x1); (X1> X3 > X2, as shown in annotated Fig. 1 below). PNG media_image1.png 576 752 media_image1.png Greyscale distal polarizing film (Fig. 1 element 16) axially aligned with the optical axis, positioned at a fourth distance (x4) from the profile view imager (26), and oriented parallel to the proximal polarizing film (24) and the liquid crystal device (18 + 20 + 22), [0007], (as shown in Fig. 1), the fourth distance (x4) being greater than the first distance (x1), (X4 > X1, as shown I annotated Fig. below); and a light source (Fig. 1 element 14) oriented to emit illumination toward the distal polarizing film (16), (as shown in annotated Fig. 1, below (X2 < X1), (X3 >X2), (X4 > X1), (X1> X3 > X2)). Therefore, it would been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Milne by including a proximal polarizing film axially aligned with the optical axis, positioned at a second distance from the profile view imager, and oriented perpendicular to the optical axis, the second distance being less than a first distance between the container and the profile view imager; a liquid crystal device axially aligned with the optical axis, positioned at a third distance from the profile view imager, and oriented parallel to the proximal polarizing film, the third distance being greater than the second distance and less than the first distance; a distal polarizing film axially aligned with the optical axis, positioned at a fourth distance from the profile view imager, and oriented parallel to the proximal polarizing film and the liquid crystal device, the fourth distance being greater than the first distance; and a light source oriented to emit illumination toward the distal polarizing film (as taught by Furnas) for several advantages such as: allowing to determine stress as a defect in the container thus increase the device efficiency, ([0008], Furnas). Also detecting stress in a glass container during inspection allows manufacturers to ensure structural integrity, prevent premature breakage, and optimize production efficiency. Claims 19-21, 25-26 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Milne et al. (WO 2020247357 A1), hereafter Milne in view of in view of Shimizu et al. (US 5,719,679 A), hereafter Shimizu. Regarding claim 19, Milne teaches a method for imaging a container (Vessel) that is at least partially translucent and holds a liquid sample, (as shown in the method steps in Figs. 9-10), [0049-0050], the method comprising: illuminating the container with a ring light, the ring light being coaxially aligned with a central axis of the container, below the container, and oriented to emit light toward a bottom of the container (“the visual inspection system 300 may include ring LED lights both above and below the sample (e.g., continuous LED ring lights that each have a ring diameter substantially greater than the diameter of the vessel, [0038]);; capturing one or more profile view images with a profile view imager (Fig. 3 element 302a), [0032], the profile view imager having an optical axis that enters the container through a side wall of the container (“a portion of the vessel being transparent or translucent to allow light to pass through the vessel walls and into the sample within the vessel”, [0031]). Milne fail to teach capturing one or more bottom images with a bottom imager coaxially aligned with the central axis and oriented to view the bottom of the container. However, Shimizu related to inspecting containers apparatus and thus from the same field of endeavor teaches one or more bottom images with a bottom imager (Fig. 6 element 33) , [Col. 8, Lines 4-15] coaxially aligned with the central axis and oriented to view the bottom of the container (Fig. 6 element VL), ([Col. 4, lines 59-67]-[Col. 5, lines 1-4]). Therefore, it would been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Milne by including capturing one or more bottom images with a bottom imager coaxially aligned with the central axis and oriented to view the bottom of the container (as taught by Shimizu) for several advantages such as: providing a plurality of CCD cameras at optimum locations depending on respective deficiencies to be inspected and parallel processing images picked up by the CCD cameras allow to continuously inspected the whole vial from its head to its bottom thus increase the accuracy of the inspected data, ([Col. 1, lines 45-59], Shimizu). Regarding claim 20, Milne in the combination outlined above teaches the method of claim 19. Milne further teaches analyzing, by one or more processors (Fig. 6 element 610, [0050-0051]), the one or more profile view images of the container, [0053, 0068] or (b) the one or more bottom images of the container, to detect at least one defect associated with the container and/or contents of the container, (detecting particles and/or bubbles in the container, [0062]) Regarding claim 21, Milne in the combination outlined above teaches the method of claim 20. Milne further teaches wherein the at least one defect includes. (a) a particle or fiber within the container, (detecting particles and/or bubbles in the container, [0062]) or (b) a bruised container seal. Regarding claim 25, Milne in the combination outlined above teaches the method of claim 19. Milne further teaches analyzing, by one or more processors (Fig. 6 element 610, [0051, 0053]), (a) one or more profile view images of the container [0054, 0068] or (b) the one or more bottom images of the container, to classify at least one defect associated with the container and/or contents of the container, [0066, 0073]. Regarding claim 26, Milne in the combination outlined above teaches the method of claim 25. Milne further teaches analyzing, by one or more processors (Fig. 6 element 610, [0051, 0053]), the (a) one or more profile view images of the container [0054, 0068], wherein the at least one defect associated with the container and/or contents of the container is classified as one of: a particle within the container, a fiber within the container, or a bruised container seal, (“application 620 may determine sizes of those objects, and/or classes/types of those objects (e.g.,“particle” versus“bubble,” or possibly more refined categories such as “fiber,” etc.”, [0067]). Regarding claim 28, Milne in the combination outlined above teaches the method of claim 25. Milne further teaches comprising analyzing, by one or more processors (Fig. 6 element 610, [0051, 0053]), wherein the at least one defect associated with the container and/or contents of the container is classified as a particle within the container or a fiber within the container, (“application 620 may determine sizes of those objects, and/or classes/types of those objects (e.g.,“particle” versus“bubble,” or possibly more refined categories such as “fiber,” etc.”, [0067]). Milne fail to teach analyzing, by one or more processors the (b) the one or more bottom images of the container, Shimizu further teaches analyzing, by one or more processors (Fig. 2 element 21, [Col. 5, lines 56-65]) the (b) the one or more bottom images of the container, (Fig. 6 element VL), ([Col. 4, lines 59-67]-[Col. 5, lines 1-4]). Therefore, it would been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the modified device of Milne by including analyzing, by one or more processors the (b) the one or more bottom images of the container, (as taught by Shimizu) for several advantages such as: providing a plurality of CCD cameras at optimum locations depending on respective deficiencies to be inspected and parallel processing images picked up by the CCD cameras allow to continuously inspected the whole vial from its head to its bottom thus increase the accuracy of the inspected data, ([Col. 1, lines 45-59], Shimizu). Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Milne et al. (WO 2020247357 A1), hereafter Milne in view of in view of Shimizu et al. (US 5,719,679 A), hereafter Shimizu, in further view of Akkerman et al. (US 2008/0291438 A1), hereafter Akkerman. Regarding claim 29, Milne in the combination outlined above teaches the method of claim 19. Milne further teaches analyzing, by one or more processors (Fig. 6 element 610, [0051, 0053]), (a) the one or more profile view images of the container, [0054, 0068], or (b) the one or more bottom images of the container, to classify the container as either acceptable or a reject, [0002]. In the arguendo that Milne do not clearly teach classify the container as either acceptable or a reject, since paragraph ([0002], Milne) is part of the background section, Akkerman related to container’s inspection system and thus from the same field of endeavor teaches classify the container as either acceptable or a reject, (as shown in the steps of classification in Fig. 12, [0032, 0055]). Therefore, it would been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the modified device of Milne by including classify the container as either acceptable or a reject (as taught by Akkerman) for several advantages such as: permit to reduce false rejection since some possible flaws that are not real flaws, allowing to decreased the number of possible flaws without eliminating the real flaw, thus increase the device accuracy, ([0050], Akkerman). Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Milne et al. (US 2014/0177932 A1), discloses an automated visual inspection system (Fig. 1A element, [0119]), comprising: a profile view imager (Fig. 1A element 110 , [0119] and/or Fig. 6b element 1102, [0169]) having an optical axis that enters a container (Figs. 1A, 6a-b element 10, [0124]) through a side wall of the container, [0125], the container (10) being at least partially translucent, (“the walls of container 10 are sufficiently transparent at the illuminating wavelength to allow visualization of the liquid contained within”, [0121]); a ring light (Fig. 6B element 1120) that is coaxially aligned with a central axis of the container, (as shown in Fig. 6B), below the container, and oriented to emit light toward a bottom of the container, (“a container 10 illuminated by one or more rings of light-emitting diodes (LEDs) 1120 mounted above and below the container 10 as shown in FIG. 6B”, [0169]); and a holding means (Fig. 1B element 150) for supporting and/or securing the container (10), [0126]. (a) a container rotator (Fig. 1B element 150), [0126, 0135], (b) one or more additional profile view imagers (Fig. 1B element 1104) oriented parallel with a respective optical axis to view at least a portion of a respective profile of the container ,[0169]. Milne et al. (WO 2020131662 A1, discloses Visual inspection system 200 further includes an illumination system 208, an imager 212 (e.g., a charge-coupled device (CCD) camera) that is configured to acquire images and, in some embodiments, an optical system 214 that directs light to imager 212. As shown in Fig. 2 element 212 generate an image from below the container. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CARLOS G PEREZ-GUZMAN whose telephone number is (571)272-3904. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm ET. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tarifur Chowdhury can be reached at (571) 272-2287. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /CARLOS PEREZ-GUZMAN/ Examiner, Art Unit 2877 /TARIFUR R CHOWDHURY/ Supervisory Patent Examiner, Art Unit 2877
Read full office action

Prosecution Timeline

Aug 01, 2024
Application Filed
Apr 29, 2026
Non-Final Rejection mailed — §102, §103 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
82%
Grant Probability
99%
With Interview (+24.3%)
2y 3m (~3m remaining)
Median Time to Grant
Low
PTA Risk
Based on 149 resolved cases by this examiner. Grant probability derived from career allowance rate.

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