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 .
Priority
Receipt is acknowledged that application is a National Stage application of PCT PCT/EP2023/061692. Priority to EP22305668.0 with a priority date of 5/04/2022 is acknowledged under 35 USC 119(e) and 37 CFR 1.78.
Information Disclosure Statement
The IDS dated 10/28/2024 has been considered and placed in the application file.
Objection - Specification - Abstract
The abstract of the disclosure is objected to because the paragraph includes reference numbers throughout. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
1st 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 (i.e., changing from AIA to pre-AIA ) 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, 2, 3, 4, 6, 7, 8, 9, and 10 are rejected under 35 U.S.C. 103 as obvious over BREVETTI C.E.A.: "Brevetti Cea_K15 DR_Zero Contact, 100% Performance." 18 May 2021, https://www.youtube.com/watch?v=4LvuzjZ4lr4. (Brevetti CEA) in view of CA Patent Publication 2009 2714294 A1, (Cadieux et al.).
Claim 1
[AltContent: textbox ((Brevetti C.E.A., 4:17) shows the image of a flange of the tube of a syringe being taken by a device. The image includes the background comprising of black and white ad well as an apparent edge detection mechanism shown in the light blue lines.)]Regarding claim 1, Brevetti CEA teach a method for inspecting aspects of a medical device comprising: causing, with at least one processor, an image of a tube of a syringe to be captured via an image capture device, wherein the image comprises an
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image of a flange of the tube of the syringe superimposed on a background, wherein the background comprises a first color and a second color, wherein the first color of the background is white, and wherein the second color of the background is black; and performing an edge detection procedure on the image of the flange of the tube (Brevetti C.E.A., 4:17).
Brevetti CEA do not explicitly teach all of determining, with at least one processor, a measurement of a diameter of the flange of the tube based on the edge detection procedure performed on the image of the flange of the tube; and providing, with at least one processor, data associated with the measurement of the diameter of the flange of the tube.
[AltContent: textbox (Figure 1 shows the internal diameter of the syringe measured as Di.)]
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However, Cadieux et al. teach determining, with at least one processor, a measurement of a diameter of the flange of the tube based on the edge detection procedure performed on the image of the flange of the tube; ("The processor is configured to detect, in the captured image, a first internal wall of the syringe and a second internal wall of the syringe with an edge-detection algorithm, and to measure a distance between the first internal wall and the second internal wall to determine an internal diameter of the syringe," pg. 2, line 16) and providing, with at least one processor, data associated with the measurement of the diameter of the flange of the tube ("The captured images are provided to a processor 105, which evaluates the image to determine the internal diameter Di of syringe," pg. 3, line 32).
Therefore, taking the teachings of Brevetti CEA and Cadieux et al. as a whole, it would have been obvious to a person having ordinary skill in the art before the time of the effective filing date of the claimed invention of the instant application to modify the automatic syringe defect detection apparatus as taught by Brevetti CEA to use measuring the diameter of the flange of the tube as taught by Cadieux et al. The suggestion/motivation for doing so would have been that, “To achieve accurate flow rates and to determine the available and remaining volume of syringe, it is desirable to know the internal diameter of the syringe” as noted by the Cadieux et al. disclosure in page 1, line 11, which also motivates combination because the combination would predictably have a higher accuracy as there is a reasonable expectation that measuring the flange diameter will directly reveal defects; and/or because doing so merely combines prior art elements according to known methods to yield predictable results.
The rejection of method claim 1 above applies mutatis mutandis to the corresponding limitations of system claim 6 while noting that the rejection above cites to both device and method disclosures. Claim 6 is mapped below for clarity of the record and to specify any new limitations not included in claim 1.
Claim 2
[AltContent: textbox ((Brevetti C.E.A., 4:17) shows the flange edge detection mechanism shown in the light blue lines as the defined edge.)]
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Regarding claim 2, Brevetti CEA teach wherein performing the edge detection procedure on the image of the flange of the tube comprises: performing the edge detection procedure on the image of the flange of the tube to provide a defined edge of the flange of the tube (Brevetti C.E.A., 4:17).
Brevetti CEA do not explicitly teach all of wherein determining the measurement of the diameter of the flange of the tube comprises: determining the measurement of the diameter of the flange of the tube based on the defined edge of the flange of the tube.
However, Cadieux et al. teach wherein determining the measurement of the diameter of the flange of the tube comprises: determining the measurement of the diameter of the flange of the tube based on the defined edge of the flange of the tube ("To determine the internal diameter Di of barrel 153 of syringe 150, processor 105 may employ an edge detection algorithm. When a captured image of syringe 150 is provided to processor 105, the processor evaluates the image in a predetermined horizontal orientation to locate internal surfaces (e.g., opposite sides of a circular barrel) or "walls" of barrel 153, based upon detected sharp changes in the luminous intensity of the captured image along the horizontal orientation," pg. 4, line 12).
Brevetti CEA and Cadieux et al. are combined as per claim 1.
Claim 3
[AltContent: textbox ((Brevetti C.E.A., 4:15) shows the white and black surface colors of the device holding the syringe tubes.)]
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Regarding claim 3, Brevetti CEA teach positioning the tube within a structure, wherein a surface of the structure comprises the first color and the second color (Brevetti C.E.A., 4:15).
Claim 4
[AltContent: textbox ((Brevetti C.E.A., 2:37) shows the two components securing the syringe barrels between them.)]
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Regarding claim 4, Brevetti CEA teach wherein the structure comprises a first component and a second component, and wherein the structure is configured to hold the tube between the first component and the second component (Brevetti C.E.A., 2:37).
Claim 6
Regarding claim 6, Brevetti CEA teach a system for inspecting aspects of a medical device, comprising: a structure configured to a hold a tube for inspection; (Brevetti C.E.A., 3:44) and at
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least one processor programmed or configured to: cause an image of a tube of a syringe to be captured via an image capture device when [AltContent: textbox ((Brevetti C.E.A., 3:44) shows the structure configured to hold tubes for inspection.)]the tube is positioned in the structure, wherein the image comprises an image of a
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flange of the tube of the syringe superimposed on a background, wherein the background comprises a first color and a second color, wherein the first color of the [AltContent: textbox ((Brevetti C.E.A., 4:17) shows the image of a flange of the tube of a syringe being taken by a device. The image includes the background comprising of black and white ad well as an apparent edge detection mechanism shown in the light blue lines.)]background is white and wherein the second color of the background is black; and performing an edge detection procedure on the image of the flange of the tube (Brevetti C.E.A., 4:17).
Brevetti CEA do not explicitly teach all of determine a measurement of a diameter of the flange of the tube based on the edge detection procedure performed on the image of the flange of the tube; and provide data associated with the measurement of the diameter of the flange of the tube.
However, Cadieux et al. teach determine a measurement of a diameter of the flange of the tube based on the edge detection procedure performed on the image of the flange of the tube; ("The processor is configured to detect, in the captured image, a first internal wall of the syringe and a second internal wall of the syringe with an edge-detection algorithm, and to measure a distance between the first internal wall and the second internal wall to determine an internal diameter of the syringe," pg. 2, line 16) and provide data associated with the measurement of the diameter of the flange of the tube ("The captured images are provided to a processor 105, which evaluates the image to determine the internal diameter Di of syringe," pg. 3, line 32).
Brevetti CEA and Cadieux et al. are combined as per claim 1.
Claim 7
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Regarding claim 7, Brevetti CEA teach at least one light source, wherein the at least one light source is configured to illuminate the flange of the tube (Brevetti C.E.A., 3:44).
[AltContent: textbox ( (Brevetti C.E.A., 3:44) shows the light source illuminating the entirety of the flange and tube of the syringe.)]
Claim 8
[AltContent: textbox ((Brevetti C.E.A., 4:17) shows the flange edge detection mechanism shown in the light blue lines as the defined edge.)]
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Regarding claim 8, Brevetti CEA teach when performing the edge detection procedure on the image of the flange of the tube, the at least one processor is further programmed or configured to: perform the edge detection procedure on the image of the flange of the tube to provide a defined edge of the flange of the tube (Brevetti C.E.A., 4:17).
Brevetti CEA do not explicitly teach all of wherein, when determining the measurement of the diameter of the flange of the tube, the at least one processor is programmed or configured to: determine the measurement of the diameter of the flange of the tube based on the defined edge of the flange of the tube.
However, Cadieux et al. teach wherein, when determining the measurement of the diameter of the flange of the tube, the at least one processor is programmed or configured to: determine the measurement of the diameter of the flange of the tube based on the defined edge of the flange of the tube ("To determine the internal diameter Di of barrel 153 of syringe 150, processor 105 may employ an edge detection algorithm. When a captured image of syringe 150 is provided to processor 105, the processor evaluates the image in a predetermined horizontal orientation to locate internal surfaces (e.g., opposite sides of a circular barrel) or "walls" of barrel 153, based upon detected sharp changes in the luminous intensity of the captured image along the horizontal orientation," pg. 4, line 12).
Brevetti CEA and Cadieux et al. are combined as per claim 1.
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Claim 9
[AltContent: textbox ((Brevetti C.E.A., 4:15) shows the white and black surface colors of the device holding the syringe tubes.)]Regarding claim 9, Brevetti CEA teach a tube positioned within the structure, wherein a surface of the structure comprises the first color and the second color (Brevetti C.E.A., 4:15) .
Claim 10
[AltContent: textbox ((Brevetti C.E.A., 2:37) shows the two components securing the syringe barrels between them. )]
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Regarding claim 10, Brevetti CEA teach wherein the structure comprises a first component and a second component, and wherein the structure is configured to hold the tube between the first component and the second component (Brevetti C.E.A., 2:37).
2nd Claim Rejections - 35 USC § 103
Claims 5 and 11 are rejected under 35 U.S.C. 103 as obvious over BREVETTI C.E.A.: "Brevetti Cea_K15 DR_Zero Contact, 100% Performance." 18 May 2021, https://www.youtube.com/watch?v=4LvuzjZ4lr4. (Brevetti CEA) in view of CA Patent Publication 2009 2714294 A1, (Cadieux et al.) and CMP PHAR.MA. SRL.: "SA12J prefilled syringes inspection machine." 9 May 2016, https://www.youtube.com/watch?v=GlojLwZeX0o. (CMP PHARMA)
Claim 5
[AltContent: textbox ((Brevetti C.E.A., 3:44) shows the light source illuminating the entirety of the flange and tube of the syringe prior to the image capture.)]
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Regarding claim 5, Brevetti CEA teach causing light to illuminate the tube via at least one light source prior to causing the image of the tube to be captured via an image capture device, wherein the at least one light source comprises a spot light (Brevetti C.E.A., 3:44).
Brevetti CEA do not explicitly teach all of causing light to illuminate the tube via at least one light source prior to causing the image of the tube to be captured via an image capture device, wherein the at least one light source comprises a spot light and a ring light.
[AltContent: textbox ((CMP PHAR.MA. SRL, 1:04) shows the ring light illuminating the tube of the syringe prior to the image capture.)]
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However, CMP PHARMA teach causing light to illuminate the tube via at least one light source prior to causing the image of the tube to be captured via an image capture device, wherein the at least one light source comprises a spot light and a ring light (CMP PHAR.MA. SRL, 1:04).
Therefore, taking the teachings of Brevetti CEA, Cadieux et al., and CMP PHARMA as a whole, it would have been obvious to a person having ordinary skill in the art before the time of the effective filing date of the claimed invention of the instant application to modify automatic syringe defect detection apparatus as taught by Brevetti CEA and measuring the diameter of the flange of the tube as taught by Cadieux et al. to use a ring light as taught by CMP PHARMA because such a modification is based on the use of known techniques to improve similar devices in the same way. More specifically, the light included in the Brevetti CEA device is comparable to the ring light proposed by CMP PHARMA. Therefore, it is within the capabilities of one of ordinary skill in the art to modify the light included in the Brevetti CEA device to include a ring light with the predictable result of improving illumination for defect detection, thereby increasing the accuracy and reliability of the flange measurements.
Claim 11
[AltContent: textbox ((Brevetti C.E.A., 3:44) shows the light source illuminating the entirety of the flange and tube of the syringe prior to the image capture.)]
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Regarding claim 11, Brevetti CEA teach wherein the at least one processor is further programmed or configured to: cause light to illuminate the tube via at least one light source prior to causing the image of the tube to be captured via an image capture device, wherein the at least one light source comprises a spot light (Brevetti C.E.A., 3:44).
Brevetti CEA do not explicitly teach all of to cause light to illuminate the tube via at least one light source prior to causing the image of the tube to be captured via an image capture device, wherein the at least one light source comprises a spot light and a ring light.
[AltContent: textbox ((CMP PHAR.MA. SRL, 1:04) shows the ring light illuminating the tube of the syringe prior to the image capture.)]
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However, CMP PHARMA teach to cause light to illuminate the tube via at least one light source prior to causing the image of the tube to be captured via an image capture device, wherein the at least one light source comprises a spot light and a ring light (CMP PHAR.MA. SRL, 1:04).
Brevetti CEA, Cadieux et al., and CMP PHARMA are combined as per claim 5.
Reference Cited
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure.
US Patent Publication 2024 0054654 A1 to Jiang discloses foreign object automatic detection in pharmaceutical drug containers.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARSTEN F LANTZ whose telephone number is (571) 272-4564. The examiner can normally be reached Monday-Friday 8:00-4:00.
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/Karsten F. Lantz/Examiner, Art Unit 2664
Date: 6/30/2026
/JENNIFER MEHMOOD/Supervisory Patent Examiner, Art Unit 2664
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